A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma.
- Conditions
- Follicular LymphomaMarginal Zone Lymphoma
- Interventions
- Registration Number
- NCT04680052
- Lead Sponsor
- Incyte Corporation
- Brief Summary
This is a Phase 3 double-blind, placebo-controlled, randomized study designed to investigate whether tafasitamab and lenalidomide as an add-on to rituximab provides improved clinical benefit compared with lenalidomide as an add-on to rituximab in patients with R/R FL Grade 1 to 3a or R/R MZL.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 654
- Histologically confirmed Grade 1, 2, or 3a FL or nodal MZL, splenic MZL, or extra nodal MZL
- Willingness to avoid pregnancy or fathering children
- In the opinion of the investigator, be able and willing to receive adequate mandatory prophylaxis and/or therapy for thromboembolic events (eg, aspirin 70-325 mg daily or low-molecular-weight heparin)
- Previously treated with at least 1 prior systemic anti-CD20 immunotherapy or chemo-immunotherapy
- Documented relapsed, refractory, or PD after treatment with systemic therapy
- ECOG performance status of 0 to 2
- Women who are pregnant or breastfeeding.
- Any histology other than FL and MZL or clinical evidence of transformed lymphoma
- Prior non-hematologic malignancy
- Congestive heart failure
- HCV positivity, chronic HBV infection or history of HIV infection
- Active systemic infection
- CNS lymphoma involvement
- Any systemic anti-lymphoma and/or investigational therapy within 28 days prior to the start of Cycle 1
- Prior use of lenalidomide in combination with rituximab
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A : tafasitamab + rituximab + lenalidomide lenalidomide Adult patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) Grade 1 to 3a or R/R Marginal Zone Lymphoma (MZL) Arm B : placebo+rituximab+lenalidomide lenalidomide Adult patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) Grade 1 to 3a or R/R Marginal Zone Lymphoma (MZL) Arm B : placebo+rituximab+lenalidomide placebo Adult patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) Grade 1 to 3a or R/R Marginal Zone Lymphoma (MZL) Arm A : tafasitamab + rituximab + lenalidomide rituximab Adult patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) Grade 1 to 3a or R/R Marginal Zone Lymphoma (MZL) Arm A : tafasitamab + rituximab + lenalidomide tafasitamab Adult patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) Grade 1 to 3a or R/R Marginal Zone Lymphoma (MZL) Arm B : placebo+rituximab+lenalidomide rituximab Adult patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) Grade 1 to 3a or R/R Marginal Zone Lymphoma (MZL)
- Primary Outcome Measures
Name Time Method FL Population: Progression-free Survival (PFS) by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented Disease Progression (PD), or Death From Any Cause, Whichever Occurred First up to approximately 34 months PD, positron emission tomography (PET): score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new fluorodeoxyglucose (FDG)-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, computed tomography (CT): abnormal individual node/lesion with longest diameter (LDi ) \>1.5 centimeters (cm) and increase by ≥50% from the product of the perpendicular diameters (PPD) nadir and increase in LDi or shortest diameter (SDi) from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma.
FL Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First up to 2 years PD, PET: score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new FDG-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, CT: abnormal individual node/lesion with LDi \>1.5 cm and increase by ≥50% from the PPD nadir and increase in LDi or SDi from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start.
- Secondary Outcome Measures
Name Time Method Overall Population: Health State EQ-5D-5L Scores at Baseline and End of Treatment up to approximately 34 months The EQ-5D-5L contains a participant-reported score regarding health state measured on a visual analog scale (scores range from 0 \[worst imaginable health state\] to 100 \[best imaginable health state\]), and 5 questions on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The 5 questions have 5 response levels: 1, no problems; 2, slight problems; 3, moderate problems; 4, severe problems; and 5, unable to/extreme problems.
Overall Population: PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First up to approximately 34 months PD, PET: score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new FDG-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, CT: abnormal individual node/lesion with LDi \>1.5 cm and increase by ≥50% from the PPD nadir and increase in LDi or SDi from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma.
Overall Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First up to 2 years PD, PET: score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new FDG-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, CT: abnormal individual node/lesion with LDi \>1.5 cm and increase by ≥50% from the PPD nadir and increase in LDi or SDi from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start.
FDG-avid FL Population: Positron Emission Tomography-Complete Response (PET-CR) Rate by Investigator Assessment, Using the Lugano 2014 Criteria up to approximately 34 months CR was defined as a complete metabolic response at any time after the start of treatment. Per PET, CR criteria: (1) score of 1, 2, or 3 with or without a residual mass on a 5-point scale for lymph nodes and extralymphatic sites; (2) No evidence of FDG-avid disease in bone marrow; and (3) no new lesions. PET 5-point scale: 1 = no uptake above background; 2 = uptake ≤ mediastinum; 3 = uptake \> mediastinum but ≤ liver; 4 = uptake moderately \> liver; 5 = uptake markedly higher than liver and/or new lesions; X = new areas of uptake unlikely to be related to lymphoma.
FL Population: Overall Survival up to approximately 34 months Overall survival was defined as the time from randomization until death from any cause.
FL Population: Kaplan-Meier Estimates of Overall Survival up to 2 years Overall survival was defined as the time from randomization until death from any cause. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start.
FDG-avid Overall Population: PET-CR Rate by Investigator Assessment, Using the Lugano 2014 Criteria up to approximately 34 months CR was defined as a complete metabolic response at any time after the start of treatment. Per PET, CR criteria: (1) score of 1, 2, or 3 with or without a residual mass on a 5-point scale for lymph nodes and extralymphatic sites; (2) No evidence of FDG-avid disease in bone marrow; and (3) no new lesions. PET 5-point scale: 1 = no uptake above background; 2 = uptake ≤ mediastinum; 3 = uptake \> mediastinum but ≤ liver; 4 = uptake moderately \> liver; 5 = uptake markedly higher than liver and/or new lesions; X = new areas of uptake unlikely to be related to lymphoma. The Overall FDG-avid Set included all randomized participants with a PET scan at Baseline with a resulting Deauville score of 4 or 5.
FL Population: Minimal Residual Disease (MRD)-Negativity Rate (at Threshold of 10^-5) at End of Treatment up to approximately 34 months The MRD-negativity rate was defined as the percentage of participants who achieved a negative MRD result in peripheral blood at the End of Treatment. The threshold used for the analysis was 10\^-5 cells. MRD status was only analyzed with a threshold of ≤10\^-5 cells for MRD negativity.
Overall Population: MRD-negativity Rate (at Threshold of 10-5) at End of Treatment up to approximately 34 months The MRD-negativity rate was defined as the percentage of participants who achieved a negative MRD result in peripheral blood at the End of Treatment. The threshold used for the analysis was 10\^-5 cells. MRD status was only analyzed with a threshold of ≤10\^-5 cells for MRD negativity. The Overall MRD Blood-Evaluable Set included all participants in the Full Analysis Set who received at least 1 dose of study treatment with identifiable clonality in blood samples at Cycle 1 Day 1.
FL Population: Overall Response Rate (Percentage of Participants Who Achieved a CR/PR Per the Lugano Classification at Any Time During the Study But Before the First PD and Before/at the Start of a New Antilymphoma Treatment) by Investigator Assessment up to approximately 34 months PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.
Overall Population: Overall Response Rate (Percentage of Participants Who Achieved a CR/PR Per Lugano Classification at Any Time During the Study But Before the First PD and Before/at the Start of a New Antilymphoma Treatment) by Investigator Assessment up to approximately 34 months PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.
FL Population: Duration of Response (DOR; the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment up to approximately 34 months PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.
FL Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment up to 2 years PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.
Overall Population: DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment up to approximately 34 months PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.
Overall Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment up to 2 years PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.
Overall Population: Overall Survival up to approximately 34 months Overall survival was defined as the time from randomization until death from any cause.
Overall Population: Kaplan-Meier Estimates of Overall Survival up to 2 years Overall survival was defined as the time from randomization until death from any cause. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start.
FL Population: PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First up to approximately 34 months PD, PET: score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new FDG-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, CT: abnormal individual node/lesion with LDi \>1.5 cm and increase by ≥50% from the PPD nadir and increase in LDi or SDi from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma.
FL Population: Kaplan-Meier Estimates of PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First up to 2 years PD, PET: score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new FDG-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, CT: abnormal individual node/lesion with LDi \>1.5 cm and increase by ≥50% from the PPD nadir and increase in LDi or SDi from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start.
Overall Population: PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First up to approximately 34 months PD, PET: score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new FDG-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, CT: abnormal individual node/lesion with LDi \>1.5 cm and increase by ≥50% from the PPD nadir and increase in LDi or SDi from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma.
Overall Population: Kaplan-Meier Estimates of PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First up to 2 years PD, PET: score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new FDG-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, CT: abnormal individual node/lesion with LDi \>1.5 cm and increase by ≥50% from the PPD nadir and increase in LDi or SDi from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start.
FL Population: Overall Response Rate (Percentage of Participants Who Achieved a CR/PR Per the Lugano Classification at Any Time During the Study But Before the First PD and Before/at the Start of a New Antilymphoma Treatment) by IRC Review up to approximately 34 months PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.
Overall Population: Overall Response Rate (Percentage of Participants Who Achieved a CR/PR Per Lugano Classification at Any Time During the Study But Before the First PD and Before/at the Start of a New Antilymphoma Treatment) by IRC Review up to approximately 34 months PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.
FL Population: DOR the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review up to approximately 34 months PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.
FL Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review up to 2 years PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.
Overall Population: DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review up to approximately 34 months PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.
Overall Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review up to 2 years PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.
FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment up to approximately 34 months The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-30 (EORTC QLQ-C30) version 3 is a 30-item scale composed of both multi-item scales and single-item measures. These include 5 functional scales (physical functioning, role, cognitive functioning, emotional functioning, and social functioning), 3 symptom scales (fatigue, pain, and nausea/vomiting), a global health status scale, and 6 single items (constipation, diarrhea, sleep, dyspnea, appetite, financial). All scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Therefore, a high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status/QoL represents a high QoL. A high score for a symptom scale/item represents a high level of symptomatology/problems. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment up to approximately 34 months The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-30 (EORTC QLQ-C30) version 3 is a 30-item scale composed of both multi-item scales and single-item measures. These include 5 functional scales (physical functioning, role, cognitive functioning, emotional functioning, and social functioning), 3 symptom scales (fatigue, pain, and nausea/vomiting), a global health status scale, and 6 single items (constipation, diarrhea, sleep, dyspnea, appetite, financial). All scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Therefore, a high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status/QoL represents a high QoL. A high score for a symptom scale/item represents a high level of symptomatology/problems. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
FL Population: Health State EQ-5D-5L Scores at Baseline and End of Treatment up to approximately 34 months The EQ-5D-5L contains a participant-reported score regarding health state measured on a visual analog scale (scores range from 0 \[worst imaginable health state\] to 100 \[best imaginable health state\]), and 5 questions on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The 5 questions have 5 response levels: 1, no problems; 2, slight problems; 3, moderate problems; 4, severe problems; and 5, unable to/extreme problems.
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment up to approximately 34 months The EQ-5D-5L contains a participant-reported score regarding health state measured on a visual analog scale (scores range from 0 \[worst imaginable health state\] to 100 \[best imaginable health state\]), and 5 questions on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The 5 questions have 5 response levels: 1, no problems; 2, slight problems; 3, moderate problems; 4, severe problems; and 5, unable to/extreme problems.
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment up to approximately 34 months The EQ-5D-5L contains a participant-reported score regarding health state measured on a visual analog scale (scores range from 0 \[worst imaginable health state\] to 100 \[best imaginable health state\]), and 5 questions on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The 5 questions have 5 response levels: 1, no problems; 2, slight problems; 3, moderate problems; 4, severe problems; and 5, unable to/extreme problems.
FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment up to approximately 34 months The FACT-Lymphoma (v4) is composed of 42 items with a 5-point Likert-type scale and 5 subscales. Physical well-being (PWB) subscale: 7 items measured on 0- to 4-point scale; total score = 0-28. Social/family well-being (SWB) subscale: 7 items measured on 0- to 4-point scale; total score = 0-28. Emotional well-being (EWB) subscale: 6 items measured on 0- to 4-point scale; total score = 0-24. Functional well-being (FWB) subscale: 7 items measured on 0- to 4-point scale; total score = 0-28. Lymphoma (LymS) subscale includes 15 items; total score = 0-60. Three total scores can be derived by adding the subscales: FACT-Lymphoma Trial Outcome Index (TOI): (PWB score) + (FWB score) + (LymS score); total score = 0-116. FACT-G total score: (PWB score) + (SWB score) + (EWB score) + (FWB score); total score = 0-108. FACT-Lymphoma total score: (PWB score) + (SWB score) + (EWB score) + (FWB score) + (LymS score); total score = 0-168. The higher the score, the better the quality of life.
Overall Population: FACT-Lym Scores at Baseline and End of Treatment up to approximately 34 months The FACT-Lymphoma (v4) is composed of 42 items with a 5-point Likert-type scale and 5 subscales. Physical well-being (PWB) subscale: 7 items measured on 0- to 4-point scale; total score = 0-28. Social/family well-being (SWB) subscale: 7 items measured on 0- to 4-point scale; total score = 0-28. Emotional well-being (EWB) subscale: 6 items measured on 0- to 4-point scale; total score = 0-24. Functional well-being (FWB) subscale: 7 items measured on 0- to 4-point scale; total score = 0-28. Lymphoma (LymS) subscale includes 15 items; total score = 0-60. Three total scores can be derived by adding the subscales: FACT-Lymphoma Trial Outcome Index (TOI): (PWB score) + (FWB score) + (LymS score); total score = 0-116. FACT-G total score: (PWB score) + (SWB score) + (EWB score) + (FWB score); total score = 0-108. FACT-Lymphoma total score: (PWB score) + (SWB score) + (EWB score) + (FWB score) + (LymS score); total score = 0-168. The higher the score, the better the quality of life.
Trial Locations
- Locations (259)
John Muir Health Clinical Research Center
🇺🇸Concord, California, United States
Metro-Minnesota Community Oncology Reserch Consortium (Mmcorc)
🇺🇸Saint Louis Park, Minnesota, United States
Hattiesburg Clinic Hematology
🇺🇸Hattiesburg, Mississippi, United States
Md Anderson Cancer Center
🇺🇸Houston, Texas, United States
Straub Medical Center
🇺🇸Honolulu, Hawaii, United States
Aarhus University Hospital
🇩🇰Aarhus, Denmark
Sjaellands Universitetshospital Naestved
🇩🇰Roskilde, Denmark
Integris Cancer Institute
🇺🇸Oklahoma City, Oklahoma, United States
Barbara Ann Karmanos Cancer Hospital
🇺🇸Detroit, Michigan, United States
University Hospitals Birmingham Nhs Foundation Trust
🇬🇧Birmingham, United Kingdom
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Utah Cancer Specialists
🇺🇸Salt Lake City, Utah, United States
Marin Cancer Care
🇺🇸Greenbrae, California, United States
Sharp Memorial Hospital
🇺🇸San Diego, California, United States
The Oncology Institute of Hope and Innovation
🇺🇸Pasadena, California, United States
Cancer Specialists of North Florida
🇺🇸Jacksonville, Florida, United States
Brcr Medical Center, Inc
🇺🇸Plantation, Florida, United States
Asclepes Research Centers
🇺🇸Weeki Wachee, Florida, United States
University of Maryland-Greenebaum Cancer Center
🇺🇸Baltimore, Maryland, United States
Levine Cancer Institute
🇺🇸Charlotte, North Carolina, United States
Nyu Clinical Cancer Center
🇺🇸New York, New York, United States
Prisma Health Upstate
🇺🇸Greenville, South Carolina, United States
Texas Oncology-Baylor Charles A. Sammons
🇺🇸Dallas, Texas, United States
The Center For Cancer and Blood Disorders
🇺🇸Fort Worth, Texas, United States
Lyndon B Johnson General Hospital
🇺🇸Houston, Texas, United States
Renovatio Clinical
🇺🇸Spring, Texas, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Vista Oncology Inc Ps
🇺🇸Olympia, Washington, United States
Northwest Medical Specialties Pllc
🇺🇸Tacoma, Washington, United States
Gold Coast Hospital
🇦🇺Southport, Queensland, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Northern Hospital
🇦🇺Melbourne, Victoria, Australia
Eastern Health
🇦🇺Box Hill, Australia
Perth Blood Institute
🇦🇺West Perth, Western Australia, Australia
Royal Hobart Hospital
🇦🇺Hobart, Australia
Landeskrankenhaus Universitatsklinikum Graz
🇦🇹Graz, Austria
Innsbruck University Hospital
🇦🇹Innsbruck, Austria
Kepler Universitat Klinikum
🇦🇹Linz, Austria
A.Z. St.-Jan-Dienst Hematologie
🇧🇪Brugge, Belgium
Cliniques Universitaires Ucl Saint-Luc
🇧🇪Brussels, Belgium
Universitair Ziekenhuis Antwerpen, Dienst Hematologie
🇧🇪Edegem, Belgium
AZ Delta
🇧🇪Roeselare, Belgium
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Chu de Quebec - Universite Laval (Chul)
🇨🇦Québec, Quebec, Canada
University
🇨🇿Brno, Czechia
University Hospital Hradec Kralove
🇨🇿Hradec Kralove, Czechia
University Hospital Ostrava
🇨🇿Ostrava, Czechia
Vseobecna Fakultni Nemocnice
🇨🇿Prague, Czechia
University Hospital Kralovkse Vinohrady
🇨🇿Praha, Czechia
Aalborg University Hospital
🇩🇰Aalborg, Denmark
University Hospital Motol
🇨🇿Praha, Czechia
Odense University Hospital
🇩🇰Odense, Denmark
Kuopio University Hospital
🇫🇮Kuopio, Finland
Oulu University Hospital
🇫🇮Oulu, Finland
Tampere University Hospital
🇫🇮Tampere, Finland
Chu Amiens Picardie - Hopital Sud
🇫🇷Amiens, France
Turku University Hospital
🇫🇮Turku, Finland
Chu Angers Hotel Dieu Nord
🇫🇷Angers, France
Groupe Bordeaux Nord Aquitaine Gbna Polycliniques - Polyclinique Bordeaux Nord Aquitaine Pbna
🇫🇷Bordeaux, France
Centre Hospitalier de Versailles - Hopital Andre Mignot
🇫🇷Le Chesnay, France
Centre Hospitalier Universitaire Chu Dijon Bourgogne - Hopital Francois Mitterrand
🇫🇷Dijon, France
CHU Nantes
🇫🇷Nantes, France
A.P.H. Paris Hopital Cochin
🇫🇷Paris, France
Hospital Saint-Louis Service Oncologie Medicale
🇫🇷Paris, France
Hôpital Pitié Salpêtrière
🇫🇷Paris, France
Centre Hospitalier de Pontoise
🇫🇷Pontoise, France
Chru Hopitaux de Tours Hospital Bretonneau
🇫🇷Tours, France
Centre Hospitalier Annecy-Genevois
🇫🇷Pringy, France
Klinikum St. Marien Amberg
🇩🇪Amberg, Germany
Universitaetsmedizin Greifswald
🇩🇪Greifswald, Germany
University Clinic Giessen Und Marburg Ukgm
🇩🇪GIEßEN, Germany
Klinik Fur Innere Medizin Hamatologie and Onkologie
🇩🇪Berlin, Germany
Universitatsklinikum Essen
🇩🇪Essen, Germany
Universitatsklinikum Munster
🇩🇪Muenster, Germany
Statistics and Data Corporation (Sdc)
🇩🇪Landshut, Germany
Medizinische Fakultaet Mannheim Der Universitaet Heidelberg
🇩🇪Mannheim, Germany
Onkologische Schwerpunktpraxis
🇩🇪Oldenburg, Germany
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
🇩🇪Mainz, Germany
Universitaetsklinikum Wuerzburg
🇩🇪Würzburg, Germany
University Hospital of West Attica - Attikon
🇬🇷Athens, Greece
National Institute of Oncology
🇭🇺Budapest, Hungary
Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika
🇭🇺Debrecen, Hungary
Markhot Ferenc Korhaz
🇭🇺Eger, Hungary
Shamir Medical Center Formerly Assaf Harofeh Medical Center
🇮🇱Beer Yaaqov, Israel
Ha Emek Medical Center
🇮🇱Afula, Israel
Soroka
🇮🇱Bear Sheva, Israel
Wolfson
🇮🇱Holon, Israel
"Laiko" General Hospital of Athens, Hematology of the First Propaedeutic Internal Medicine Clinic
🇮🇱Jerusalem, Israel
Meir Medical Center
🇮🇱Kfar Saba, Israel
Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari
🇮🇹Bari, Italy
Fondazione Del Piemonte Per L Oncologia Ircc Candiolo
🇮🇹Candiolo, Italy
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
🇮🇹Brescia, Italy
Presidio Ospedaliero Vito Fazzi
🇮🇹Lecce, Italy
Divisione Clinicizzata Di Ematologia
🇮🇹Catania, Italy
Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano
🇮🇹Milano, Italy
Istituto Nazionale Tumori Irccs Fondazione Pascale
🇮🇹Naples, Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
🇮🇹Milano, Italy
Universita Di Napoli Federico Ii
🇮🇹Napoli, Italy
Azienda Ospedaliero Universitaria Maggiore Della Carita Di Novara
🇮🇹Novara, Italy
Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano
🇮🇹Orbassano, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
🇮🇹Palermo, Italy
Ausl Di Placenza Ospedale Guglielmo Da Saliceto
🇮🇹Piacenza, Italy
Uo Ematologia Univ - Aoup Santa Chiara Pisa
🇮🇹Pisa, Italy
Ospedale Santa Maria Delle Croci
🇮🇹Ravenna, Italy
Arcispedale Santa Maria Nuova
🇮🇹Reggio Emilia, Italy
Ausl Della Romagna
🇮🇹Rimini, Italy
Universita Degli Studi Di Roma La Sapienza - Umberto I Policlinico Di Roma - Centro Di Ematologia
🇮🇹Roma, Italy
Ospedale Sant. Eugenio
🇮🇹Rome, Italy
Irccs Azienda Ospedaliera Universitaria San Martino
🇮🇹San Martino, Italy
Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza
🇮🇹Torino, Italy
Asugi Ospedale Maggiore
🇮🇹Trieste, Italy
National Cancer Center Hospital East
🇯🇵Kashiwa-shi, Japan
Hospital of the University of Occupation and Environmental Health
🇯🇵Kitakyushu-shi, Japan
Japanese Red Cross Nagoya Daini Hospital
🇯🇵Nagoya-shi, Japan
Kobe City Medical Center General Hospital
🇯🇵Kobe-shi, Japan
Mie University Hospital
🇯🇵Tsu-shi, Japan
Osaka University Hospital
🇯🇵Suita-shi, Japan
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Dong-A University Hospital
🇰🇷Busan, Korea, Republic of
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
Daegu Catholic University Medical Center
🇰🇷Daegu, Korea, Republic of
Gacheon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Severance Hospital Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Jeonbuk National University Hospital
🇰🇷Jeonju, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea Yeoido St.Mary'S Hospital
🇰🇷Seoul, Korea, Republic of
Amsterdam University Medical Centre
🇳🇱Amsterdam, Netherlands
Hospital Rijnstate
🇳🇱Arnhem, Netherlands
Medisch Spectrum Twente
🇳🇱Enschede, Netherlands
Innlandet Hospital Trust
🇳🇴Brumunddal, Norway
Universitetssykehuset I Trondheim - St. Olavs Hospital
🇳🇴Trondheim, Norway
Pratia McM Krakow
🇵🇱Krakow, Poland
Pratia Poznan
🇵🇱Katowice, Poland
Sp Zoz Szpital Uniwersytecki
🇵🇱Krakow, Poland
Institute of Hematology and Transfusion Medicine
🇵🇱Warszawa, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1
🇵🇱Lublin, Poland
Maria Sklodowska-Curie National Research Institute of Oncology
🇵🇱Warszawa, Poland
Rostov State Medical University
🇷🇺Rostov-on-don, Russian Federation
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego
🇵🇱Wroclaw, Poland
Ico Hospital Germans Trias I Pujol
🇪🇸Badalona, Spain
Hospital General Unviersitario de Alicante
🇪🇸Alicante, Spain
Complejo Hospitalario Universitario A Coruna
🇪🇸A Coruña, Spain
Hospital Del Mar
🇪🇸Barcelona, Spain
Hospital General Universitario Vall D Hebron
🇪🇸Barcelona, Spain
Hospital de La Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
Hospital Universitario de Burgos
🇪🇸Burgos, Spain
Hospital Universitario de Cabuenes
🇪🇸Gijon, Spain
Institut Catala Doncologia Ico - Hospital Duran I Reynals Location
🇪🇸Hospitalet de Llobregat, Spain
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Spain
Hospital Universitario Ramon Y Cajal
🇪🇸Madrid, Spain
Fundacion Jimenez Diaz University Hospital
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitario Quironsalud Madrid
🇪🇸Madrid, Spain
Hospital Son Llatzer
🇪🇸Palma de Mallorca, Spain
Hospital Puerta de Hierro
🇪🇸Majadahonda, Spain
Hospital Clinico Universitario de Salamanca
🇪🇸Salamanca, Spain
Hospital Universitario Virgen de La Victoria
🇪🇸Malaga, Spain
Consorci Hospitalari Parc Tauli de Sabadell
🇪🇸Sabadell, Spain
Hospital Universitario Virgen de La Arrixaca
🇪🇸Murcia, Spain
Hospital Universitario Marques de Valdecilla
🇪🇸Santander, Spain
Hospital Universitari I Politecnic La Fe
🇪🇸Valencia, Spain
Hospital Universitario Doctor Peset
🇪🇸Valencia, Spain
Hospital Universitario Virgen del Rocio Sevilla
🇪🇸Sevilla, Spain
Hospital Universitari Mutua Terrassa
🇪🇸Terrassa, Spain
Hospital Universitario de Alava
🇪🇸Vitoria-gasteiz, Spain
Karolinska University Hospital Solna
🇸🇪Solna, Sweden
Goetalandsregionen - Uddevalla Sjukhus Us
🇸🇪Uddevalla, Sweden
Uppsala Universitet - Akademiska Sjukhuset
🇸🇪Uppsala, Sweden
University Hospital of Basel Department of Oncology
🇨🇭Basel, Switzerland
Oncological Institute of Southern Switzerland
🇨🇭Bellinzona, Switzerland
Inselspital - Universitaetsspital Bern
🇨🇭Bern, Switzerland
Kantonsspital St. Gallen
🇨🇭St. Gallen, Switzerland
Kantonsspital Winterthur
🇨🇭Winterthur, Switzerland
Universitatsspital Zurich
🇨🇭Zurich, Switzerland
E-Da Hospital
🇨🇳Kaohsiung City, Taiwan
Far Eastern Memorial Hospital
🇨🇳New Taipei City, Taiwan
China Medical University Hospital
🇨🇳Taichung, Taiwan
National Cheng Kung University (Ncku) Hospital
🇨🇳Tainan, Taiwan
Hematology and Medical Oncology Too Foundation Sun Yat Sen Cancer Center
🇨🇳Taipei City, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Tri Service General Hospital
🇨🇳Taipei, Taiwan
Institutional Review Board Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Hacettepe Universitesi Tip Fakultesi Hastanesi
🇹🇷Ankara, Turkey
Ankara University Medical Faculty
🇹🇷Ankara, Turkey
Acibadem Maslak Hospital
🇹🇷Istanbul, Turkey
National Cancer Institute of Ministry of Health
🇺🇦Kyiv, Ukraine
Communal Non-Profit Enterprise Regional Center of Oncology
🇺🇦Kharkiv, Ukraine
Leicester Royal Infirmary
🇬🇧Leicester, United Kingdom
The Royal Marsden Nhs Foundation Trust - Chelsea
🇬🇧London, United Kingdom
Bristol Haematology and Oncology Centre
🇬🇧Bristol, United Kingdom
The Royal Marsden Nhs Foundation Trust - Sutton
🇬🇧Sutton, United Kingdom
The Christie Nhs Foundation Trust Uk
🇬🇧Manchester, United Kingdom
James Cook University Hospital
🇬🇧Middlesbrough, United Kingdom
The Royal Wolverhampton Nhs Trust
🇬🇧Wolverhampton, United Kingdom
St George Hospital
🇦🇺Kogarah, New South Wales, Australia
Liverpool Hospital
🇦🇺Sydney, New South Wales, Australia
Wollongong Hospital - Illawarra Regional Hospital
🇦🇺Wollongong, New South Wales, Australia
University of Washington-Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
University of Virginia Medical Center
🇺🇸Charlottesville, Virginia, United States
Cancer Center For Blood Disorders
🇺🇸Bethesda, Maryland, United States
Northwest Georgia Oncology Centers,P.C
🇺🇸Marietta, Georgia, United States
Prairie Lakes Health Care System, Inc.
🇺🇸Watertown, South Dakota, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Universitarsfrauenklinik Ulm
🇩🇪ULM, Germany
General Hospital of Athens Laiko
🇬🇷Athens, Greece
251 Air Force General Hospital
🇬🇷Athens, Greece
Hadassah
🇮🇱Jerusalem, Israel
Sheba Medical Center
🇮🇱Tel Hashomer, Israel
Fondazione Irccs Policlinico San Matteo
🇮🇹Pavia, Italy
Pusan National University Yangsan Hospital
🇰🇷Busan-si, Korea, Republic of
Chungnam National University
🇰🇷Daejeon, Korea, Republic of
Uniwersytet Medyczny W Lodzi - Klinika Hematologii
🇵🇱Lodz, Poland
Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Petz Aladar County Teaching Hospital
🇭🇺Győr, Hungary
Szabolcs-Szatmar-Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz
🇭🇺Nyíregyháza, Hungary
Iuhw Narita Hospital
🇯🇵Narita City, Japan
*Krankenhaus*
🇦🇹Wien, Austria
Zna Stuivenberg
🇧🇪Antwerpen, Belgium
Universitair Ziekenhuis (Uz) Leuven
🇧🇪Leuven, Belgium
Chu Ucl Namur University Hospital Mont-Godinne
🇧🇪Yvoir, Belgium
Hospital Maisonneuve Rosemont
🇨🇦Montréal, Quebec, Canada
University General Hospital of Patras
🇬🇷Patras, Greece
Middlesex Hospital Cancer Center
🇺🇸Middletown, Connecticut, United States
University of Szeged
🇭🇺Szeged, Hungary
Rabin Medical Center - Beilinson Hospital
🇮🇱Petah Tikva, Israel
Szpital Spec Brzozowiepoland
🇵🇱Brzozow, Poland
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Yamagata University Hospital
🇯🇵Yamagata-shi, Japan
Institut Jules Bordet
🇧🇪Brussels, Belgium
Ghent University Hospital
🇧🇪Gent, Belgium
Centre Hospitalier Universitaire de Liege - Sart Tilman
🇧🇪Liège, Belgium
Beaumont Hospital
🇮🇪Dublin, Ireland
National Hospital Organization Kyushu Cancer Center
🇯🇵Fukuoka-shi, Japan
Chugoku Center Hospital
🇯🇵Fukuyama-shi, Japan
Kagoshima University Hospital
🇯🇵Kagoshima-shi, Japan
Saitama Medical University Hospital
🇯🇵Saitama, Japan
Juntendo University Hospital
🇯🇵Tokyo, Japan
British Columbia Cancer Agency
🇨🇦Vancouver, British Columbia, Canada
Semmelweis Egyetem
🇭🇺Budapest, Hungary
McGill University Jewish General Hospital
🇨🇦Montréal, Quebec, Canada
Shaare Zedek Mc
🇮🇱Jerusalem, Israel
Western Health
🇦🇺St. Albans, Victoria, Australia
University Hospital Galway
🇮🇪Galway, Ireland
Gifu Municipal Hospital
🇯🇵Gifu-shi, Japan
Kindai University Hospital
🇯🇵Osakasayama-shi, Japan
Medisch Centrum Leeuwarden
🇳🇱Leeuwarden, Netherlands
Specjalistyczny Szpital Onkologiczny
🇵🇱Tomaszow Mazowiecki, Poland
Pavlov First Saint Petersburg State Medical University
🇷🇺St.petersburg, Russian Federation
Norton Cancer Institute
🇺🇸Louisville, Kentucky, United States
Smilow Cancer Hospital
🇺🇸New Haven, Connecticut, United States
Tulane University
🇺🇸New Orleans, Louisiana, United States
Charleston Hematology Oncology Associates
🇺🇸Charleston, South Carolina, United States
HMC
🇳🇱Leidschendam, Netherlands
Des Moines Oncology Research Association
🇺🇸Des Moines, Iowa, United States
Baptist Health Lexington
🇺🇸Lexington, Kentucky, United States
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Flinders Medical Centre
🇦🇺Bedford Park, South Australia, Australia
Queen Elizabeth Ii Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada