A Study of Obinutuzumab (RO5072759) Plus Chemotherapy in Comparison With Rituximab Plus Chemotherapy Followed by Obinutuzumab or Rituximab Maintenance in Patients With Untreated Advanced Indolent Non-Hodgkin's Lymphoma (GALLIUM)
- Conditions
- Non-Hodgkin's Lymphoma
- Interventions
- Registration Number
- NCT01332968
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This open-label, randomized study will assess the efficacy and safety of obinutuzumab (RO5072759) in combination with chemotherapy compared to rituximab (MabThera/Rituxan) with chemotherapy followed by obinutuzumab or rituximab maintenance in participants with untreated advanced indolent non-Hodgkin's lymphoma. After the end of the induction period, participants achieving response (Complete response \[CR\] or partial response \[PR\]) will undergo a maintenance period continuing on the randomized antibody treatment alone every 2 months until disease progression for a total of 2 years. Anticipated time on study treatment is up to approximately 2.5 years. After maintenance or observation, participants will be followed for 5 years until progression. After progression, participants will be followed for new anti-lymphoma therapy and overall survival until the end of the study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1401
- Cluster of differentiation 20 (CD20)-positive indolent B-cell non-Hodgkin's lymphoma (follicular lymphoma or splenic, nodal or extranodal marginal zone lymphoma)
- Stage III or IV disease, or Stage II bulky disease (defined as tumor diameter greater than or equal to [>/=] 7 centimeters [cm])
- For participants with follicular lymphoma: requirement for treatment according to Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria
- For participants with symptomatic splenic, nodal, or non-gastric extranodal marginal zone lymphoma: disease that is de novo or has relapsed following local therapy (i.e. surgery or radiotherapy) and requires therapy as assessed by the investigator
- At least one bi-dimensionally measurable lesion (greater than [>] 2 cm in its largest dimension by computed tomography [CT] scan or magnetic resonance imaging [MRI])
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- Adequate hematologic function
- Central nervous system lymphoma, leptomeningeal lymphoma, or histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
- Grade 3b follicular lymphoma, small lymphocytic lymphoma or Waldenström's macroglobulinaemia
- Ann Arbor Stage I disease
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
- Known hypersensitivity to any of the study drugs or sensitivity to murine products, or history of sensitivity to mannitol
- For participants with follicular lymphoma: prior treatment for non-Hodgkin's lymphoma with chemotherapy, immunotherapy, or radiotherapy
- For participants with non-follicular lymphoma: prior treatment with chemotherapy or immunotherapy
- Regular treatment with corticosteroids during the 4 weeks prior to the start of Cycle 1
- Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
- For participants who will be receiving cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP): left ventricular ejection fraction (LVEF) less than (<) 50% by multiple-gated acquisition (MUGA) scan or echocardiogram
- History of prior other malignancy with the exception of curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix at any time prior to study
- Known active infection, or major episode of infection within 4 week prior to the start of Cycle 1
- Vaccination with a live vaccine within 28 days prior to randomization
- Recent major surgery (within 4 weeks prior to start of Cycle 1), other than for diagnosis
- Abnormal laboratory values as defined by protocol for creatinine, creatinine clearance, aspartate transaminase (AST) or alanine transaminase (ALT), total bilirubin, international normalized ration (INR), partial thromboplastin time (PTT) or activated partial thromboplastin time (aPPT), unless these abnormalities are due to underlying lymphoma
- Positive test results for human immunodeficiency virus (HIV), human T-lymphotropic virus 1 (HTLV1), hepatitis C or chronic hepatitis B
- Pregnant or lactating women
- Life expectancy <12 months
- Participation in another clinical trial with drug intervention within 28 days prior to start of Cycle 1 and during study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rituximab+Chemotherapy Cyclophosphamide Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. Rituximab+Chemotherapy Doxorubicin Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. Rituximab+Chemotherapy Vincristine Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. Rituximab+Chemotherapy Prednisone Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. Rituximab+Chemotherapy Bendamustine Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. Obinutuzumab+Chemotherapy Obinutuzumab Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. Rituximab+Chemotherapy Rituximab Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. Obinutuzumab+Chemotherapy Cyclophosphamide Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. Obinutuzumab+Chemotherapy Doxorubicin Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. Obinutuzumab+Chemotherapy Vincristine Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. Obinutuzumab+Chemotherapy Prednisone Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study. Obinutuzumab+Chemotherapy Bendamustine Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
- Primary Outcome Measures
Name Time Method Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed Baseline up to data cut-off (up to approximately 4 years and 7 months) Progression-free survival in participants with follicular lymphoma was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or \>/=50% increase in any node \> 1 centimeter (cm) or \>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \> 1.5 cm or \>/= 50% increase in any previously involved node with a diameter \</= 1 cm such that it is now \>1.5 cm. Tumor measurements were obtained by computed tomography (CT) or magnetic resonance imaging (MRI).
- Secondary Outcome Measures
Name Time Method Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed Baseline up to final analysis (up to 10 years) Progression-free survival in participants with follicular lymphoma was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or \>/=50% increase in any node \> 1 centimeter (cm) or \>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \> 1.5 cm or \>/= 50% increase in any previously involved node with a diameter \</= 1 cm such that it is now \>1.5 cm. Tumor measurements were obtained by computed tomography (CT) or magnetic resonance imaging (MRI).
Progression-Free Survival in the Overall Study Population, Investigator-Assessed Baseline up to data cut-off (up to approximately 5 years and 2 months) Progression-free survival in the overall study population was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or \>/=50% increase in any node \> 1 centimeter (cm) or \>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \> 1.5 cm or \>/= 50% increase in any previously involved node with a diameter \</= 1 cm such that it is now \>1.5 cm. Tumor measurements were obtained by CT/MRI.
Progression-Free Survival (Follicular Lymphoma Population), IRC-Assessed Baseline up to data cut-off (up to approximately 5 years and 2 months) Progression-free survival in the participants with follicular lymphoma was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of IRC assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or \>/=50% increase in any node \> 1 centimeter (cm) or \>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \> 1.5 cm or \>/= 50% increase in any previously involved node with a diameter \</= 1 cm such that it is now \>1.5 cm. Tumor measurements were obtained by CT/MRI. In the first 170 patients with follicular lymphoma, an FDG-PET was mandatory where a PET scanner was available.
Progression-Free Survival (Overall Study Population), Assessed by Independent Review Committee (IRC) Baseline up to data cut-off (up to approximately 5 years and 2 months) Progression-free survival in the overall study population was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of IRC assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or \>/=50% increase in any node \> 1 centimeter (cm) or \>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \> 1.5 cm or \>/= 50% increase in any previously involved node with a diameter \</= 1 cm such that it is now \>1.5 cm. Tumor measurements were obtained by CT/MRI.
Overall Response (Follicular Lymphoma Population), Investigator-Assessed Baseline up to end of induction period (up to approximately 7 months) Overall response in the follicular lymphoma population was defined as percentage of participants with PR or complete response CR determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with and without PET. CR was defined as disappearance of all target lesions; PR was defined as \>=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by \>/= 50%. Overall Response (OR) = CR + PR.
Overall Response (Overall Study Population), Investigator-Assessed Baseline up to end of induction period (up to approximately 7 months) Overall response in the overall study population was defined as percentage of participants with partial response (PR) or complete response (CR) determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without positron emission tomography (PET). CR was defined as disappearance of all target lesions; PR was defined as \>=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by \>/= 50%; Overall Response (OR) = CR + PR.
Complete Response (Follicular Lymphoma Population), Investigator-Assessed Baseline up to end of induction period (up to approximately 7 months) Percentage of participants with complete response in the follicular lymphoma population was determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions.
Complete Response (Overall Study Population), Investigator-Assessed Baseline up to end of induction period (up to approximately 7 months) Percentage of participants with complete response in the overall study population was determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions.
Overall Response (Follicular Lymphoma Population), IRC-Assessed Baseline up to end of induction period (up to approximately 7 months) Overall response in the follicular lymphoma population was defined as percentage of participants with PR or complete response CR determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions; PR was defined as \>=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by \>/= 50%. Overall Response (OR) = CR + PR.
Overall Response (Overall Study Population), IRC-Assessed Baseline up to end of induction period (up to approximately 7 months) Overall response in the overall study population was defined as percentage of participants with PR or CR determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions; PR was defined as \>=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by \>/= 50%; Overall Response (OR) = CR + PR.
Complete Response (Follicular Lymphoma Population), IRC-Assessed Baseline up to end of induction period (up to approximately 7 months) Percentage of participants with complete response in the follicular lymphoma population was determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions.
Complete Response (Overall Study Population), IRC-Assessed Baseline up to end of induction period (up to approximately 7 months)] Percentage of participants with complete response in the overall study population was determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions.
Overall Survival (Follicular Lymphoma Population) Baseline up to 10 years Overall survival in the follicular lymphoma population was defined as the time from the date of randomization to the date of death from any cause. Reported is the percentage of participants with event.
Overall Survival (Overall Study Population) Baseline up to data cut-off (up to approximately 5 years and 2 months) Overall survival in the overall study population was defined as the time from the date of randomization to the date of death from any cause. Reported is the percentage of participants with event.
Event-Free Survival (Follicular Lymphoma Population) Baseline up to 10 years Event-free survival in the follicular lymphoma population was defined as the time from the date of randomization to the date to disease progression/relapse, death from any cause, or initiation of a new anti-lymphoma treatment (NALT) on the basis of investigator assessment assessments with the use of Revised Response Criteria for Malignant Lymphoma. Disease progression/relapse was defined as at least 50% increase in nodal lesions or \>/=50% increase in any node \> 1 centimeter (cm) or \>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \> 1.5 cm or \>/= 50% increase in any previously involved node with a diameter \</= 1 cm such that it is now \>1.5 cm. Tumor measurements were obtained by CT/MRI. Reported is the percentage of participants with an event.
Event-Free Survival (Overall Study Population) Baseline up to data cut-off (up to approximately 5 years and 2 months) Event-free survival in the overall study population was defined as the time from the date of randomization to the date to disease progression/relapse, death from any cause, or initiation of a new anti-lymphoma treatment (NALT) on the basis of investigator assessment assessments with the use of Revised Response Criteria for Malignant Lymphoma. Disease progression/relapse was defined as at least 50% increase in nodal lesions or \>/=50% increase in any node \> 1 centimeter (cm) or \>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \> 1.5 cm or \>/= 50% increase in any previously involved node with a diameter \</= 1 cm such that it is now \>1.5 cm. Tumor measurements were obtained by CT/MRI. Reported is the percentage of participants with event.
Disease-Free Survival (Follicular Lymphoma Population) From first occurrence of documented CR to data cut-off (up to approximately 5 years and 2 months) Disease-free survival in the follicular lymphoma population was defined as the time from the date of the first occurrence of a documented CR to the date of disease progression/ relapse, or death from any cause for the subgroup of participants with a response of CR at any time prior to NALT on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma (RRCML). Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. Progression/relapse was defined as at least 50% increase in nodal lesions or \>/=50% increase in any node \> 1 centimeter (cm) or \>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \> 1.5 cm or \>/= 50% increase in any previously involved node with a diameter \</= 1 cm such that it is now \>1.5 cm. Reported is the percentage of participants with event.
Disease-Free Survival (Overall Study Population) From first occurrence of documented CR to data cut-off (up to approximately 5 years and 2 months) Disease-free survival in the overall study population was defined as the time from the date of the first occurrence of a documented CR to the date of disease progression/ relapse, or death from any cause for the subgroup of participants with a response of CR at any time prior to NALT on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. Progression/relapse was defined as at least 50% increase in nodal lesions or \>/=50% increase in any node \> 1 centimeter (cm) or \>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \> 1.5 cm or \>/= 50% increase in any previously involved node with a diameter \</= 1 cm such that it is now \>1.5 cm. Reported is the percentage of participants with event.
Duration of Response (DOR) (Follicular Lymphoma Population), Investigator-Assessed From first occurrence of documented CR or PR to data cut-off (up to approximately 5 years and 2 months) DOR was defined as the time from first occurrence of a documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR any time prior to NALT based on RRCML. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. PR was defined as \>/=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by \>/= 50%. Progression/relapse was defined as at least 50% increase in nodal lesions or \>/=50% increase in any node \> 1 centimeter (cm) or \>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \> 1.5 cm or \>/= 50% increase in any previously involved node with a diameter \</= 1 cm such that it is now \>1.5 cm.
Duration of Response (DOR) (Overall Study Population), Investigator-Assessed From first occurrence of documented CR or PR to data cut-off (up to approximately 4 years and 7 months) DOR was defined as the time from first occurrence of a documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR any time prior to NALT based on RRCML. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. PR was defined as \>/=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by \>/= 50%. Progression/relapse was defined as at least 50% increase in nodal lesions or \>/=50% increase in any node \> 1 centimeter (cm) or \>/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion \> 1.5 cm or \>/= 50% increase in any previously involved node with a diameter \</= 1 cm such that it is now \>1.5 cm.
Time to Next Anti-Lymphoma Treatment (Follicular Lymphoma Population) Baseline up to 10 years Time to next anti-lymphoma treatment was defined as the time from the date of randomization to the start date of the next anti-lymphoma treatment or death from any cause. Reported is the percentage of participants with event.
Time to Next Anti-Lymphoma Treatment (Overall Study Population) Baseline up to data cut-off (up to approximately 5 years and 2 months) Time to next anti-lymphoma treatment was defined as the time from the date of randomization to the start date of the next anti-lymphoma treatment or death from any cause. Reported is the percentage of participants with event.
Percentage of Participants With Adverse Events Baseline up to 10 years An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population) Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months) FACT-G consists of the following 4 FACT-Lym sub-questionnaires: Physical Well-being (range: 0-28), Social/Family Well-being (range: 0-28), Emotional Well-being (range: 0-24) and Functional Well-being (range: 0-28). Higher scores indicate better outcomes. A positive change from baseline indicates improvement. Maint = Maintenance period.
Change From Baseline in FACT-Lym Total Outcome Index (TOI) Score (Follicular Lymphoma Population) Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months) The FACT-Lym TOI Score for the follicular lymphoma population was derived from the following 3 individual FACT-Lym questionnaire subscale scores: Physical Well-being (range: 0-28), Functional Well-being (range: 0-28) and Lymphoma (range: 0-60). The FACT-Lym TOI Score is the sum of the 3 individual subscales (range 0-116). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement.
Change From Baseline in FACT-Lym Individual Subscale Lymphoma Score (Follicular Population) Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months) The FACT-Lym Individual Subscale Lymphoma Score for the follicular lymphoma population was derived from the Lymphoma subscale questionnaire (range: 0-60). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement.
Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score (Follicular Population) Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months) The FACT-Lym Total Score for the follicular lymphoma population was derived from the following 5 individual FACT-Lym questionnaire subscale scores: Physical Well-being (range: 0-28), Social/Family Well-being (range: 0-28), Emotional Well-being (range: 0-24),Functional Well-being (range: 0-28) and Lymphoma (range: 0-60). The FACT-Lym Total Score is the sum of all 5 individual subscales (range 0-168). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement.
Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Induction Phase Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 months after Day 1 of last induction cycle, Follow-up: every year up to data cut-off (up to 5 years and 2 months) The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1. Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Completion (Compl) includes completion visit and early termination visit. Maintenance/Observation is indicated as Maint/Obs.
Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Maintenance/Observation Phase Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 months after Day 1 of last induction cycle, Follow-up: every year up to data cut-off (up to 5 years and 2 months) The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1 Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Maintenance/Observation is indicated as Maint/Obs. Completion includes completion visit and early termination visit.
Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Follow Up Phase Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 after Day 1 of last induction cycle, Follow-up: every year for up to data cut-off (up to 5 years and 2 months) The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1. Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Maintenance/Observation is indicated as Maint/Obs in data categories. Completion includes completion visit and early termination visit.
Trial Locations
- Locations (183)
North York General Hospital
🇨🇦Toronto, Ontario, Canada
St Vincent'S Hospital; Haematology
🇦🇺Fitzroy, Victoria, Australia
Humber River Hospital
🇨🇦Toronto, Ontario, Canada
UZ Gent
🇧🇪Gent, Belgium
Clinique Victor Hugo
🇫🇷LeMans, France
Ottawa General Hospital
🇨🇦Ottawa, Ontario, Canada
Beilinson Medical Center; Haematology
🇮🇱Petach Tikva, Israel
Semmelweis University, First Dept of Medicine
🇭🇺Budapest, Hungary
Klinikum rechts der Isar der TU München; III. Medizinischen Klinik (Hämatologie/Onkologie)
🇩🇪München, Germany
Krankenhaus Barmherziger Brüder; Klinik für Internistische Onkologie / Hämatologie
🇩🇪Regensburg, Germany
Gemeinschaftspraxis Dr. med. Holger Klaproth
🇩🇪Neunkirchen/Saar, Germany
Chaim Sheba Medical Center; Hematology BMT & CBB
🇮🇱Ramat-Gan, Israel
Pius-Hospital; Klinik fuer Haematologie und Onkologie
🇩🇪Oldenburg, Germany
Prosper-Hospital, Medizinische Klinik I
🇩🇪Recklinghausen, Germany
Hopital De La Conception; Hematologie Clinique
🇫🇷Marseille, France
University of Debrecen Medical and Health Science Center, Institute of Internal Medicine, Hematology
🇭🇺Debrecen, Hungary
Az. Osp. S. Camillo Forlanini; Uo Ematologia E Trapianti Di Midollo Osseo
🇮🇹Roma, Lazio, Italy
Klinik Johann Wolfgang von Goethe Uni; Medizinische Klinik II
🇩🇪Frankfurt, Germany
Aomori Prefectural Central Hospital; Hematology
🇯🇵Aomori, Japan
UKSH, Campus Kiel; Klinik für Innere Medizin II, Hämatologie und Internistische Onkologie
🇩🇪Kiel, Germany
Bristol Haematology and Oncology Centre
🇬🇧Bristol, United Kingdom
Petz Aladar Megyei Korhaz; Hematologia
🇭🇺Gyor, Hungary
ASST PAPA GIOVANNI XXIII; Ematologia
🇮🇹Bergamo, Lombardia, Italy
Mannheimer Onkologie Praxis Dres. Jürgen Brust Dieter Schuster
🇩🇪Mannheim, Germany
Nagoya City University Hospital; Hematology and Oncology
🇯🇵Aichi, Japan
Brüderkrankenhaus St. Josef
🇩🇪Paderborn, Germany
Rambam Medical Center; Heamatology & Bone Marrow Transplantation
🇮🇱Haifa, Israel
The Jikei University Daisan Hospital; Department of Clinical Oncology and Hematology
🇯🇵Tokyo, Japan
Niigata Cancer Center Hospital; Internal Medicine
🇯🇵Niigata, Japan
Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, United Kingdom
Otto von Guericke Uni Magdeburg Uniklinik; Hämatologie/Onkologie
🇩🇪Magdeburg, Germany
University of Szeged, II Dept of Internal Medicine
🇭🇺Szeged, Hungary
FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF
🇷🇺Moscow, Russian Federation
Hospital Universitario la Paz; Servicio de Hematologia
🇪🇸Madrid, Spain
Kobe City Medical Center General Hospital; Hematology
🇯🇵Hyogo, Japan
Regional Clinical Hospital N.A. Semashko; Hematology
🇷🇺Nizhny Novgorod, Russian Federation
Klinikum Mannheim III. Medizinische Klinik
🇩🇪Mannheim, Germany
Aberdeen Royal Infirmary; Haematology - Ward 16
🇬🇧Aberdeen, United Kingdom
Krankenhaus der Barmherzigen Brüder Trier; Innere Medizin I, Hämatologie / Internistische Onkologie
🇩🇪Trier, Germany
Universtitätsklinikum Ulm; Klinik für Innere Medizin III
🇩🇪Ulm, Germany
National Hospital Organization Kyushu Cancer Center; Hematology
🇯🇵Fukuoka, Japan
Corporacio Sanitaria Parc Tauli; Servicio de Hematologia
🇪🇸Sabadell, Barcelona, Spain
National Institute of Oncology, A Dept of Internal Medicine
🇭🇺Budapest, Hungary
Aichi Cancer Center Hospital; Hematology and Cell Therapy
🇯🇵Aichi, Japan
Jichi Medical University Hospital; Hematology
🇯🇵Tochigi, Japan
The Cancer Institute Hospital of JFCR; Hematology Oncology
🇯🇵Tokyo, Japan
Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker
🇩🇪Würzburg, Germany
Chiba Cancer Center;Hematology and Oncology
🇯🇵Chiba, Japan
National Cancer Center Hospital East;Hematology
🇯🇵Chiba, Japan
Hospital de Basurto; Servicio de Hematologia
🇪🇸Bilbao, Vizcaya, Spain
Queen Elizabeth Hospital; Centre for Clinical Haematology
🇬🇧Birmingham, United Kingdom
Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia
🇪🇸Badalona, Barcelona, Spain
National Taiwan Universtiy Hospital; Division of Hematology
🇨🇳Taipei, Taiwan
Gunma University Hospital;Hematology
🇯🇵Gunma, Japan
Hiroshima University Hospital; Hematology
🇯🇵Hiroshima, Japan
Republican Clinical Hospital n.a. Baranov; Haematology
🇷🇺Petrozavodsk, Russian Federation
Hyogo Cancer Center; Department of hematology
🇯🇵Hyogo, Japan
Tohoku University Hospital; Hematology and Immunology
🇯🇵Miyagi, Japan
Velindre NHS Trust; Haematology Department
🇬🇧Cardiff, United Kingdom
Singleton Hospital; Pharmacy
🇬🇧Swansea, United Kingdom
Fiona Stanley Hospital
🇦🇺Murdoch, Western Australia, Australia
Cancer Hospital Chinese Academy of Medical Sciences.
🇨🇳Beijing, China
the First Hospital of Jilin University
🇨🇳Changchun, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou City, China
Sun Yet-sen University Cancer Center
🇨🇳Guangzhou, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, China
Jiangsu Cancer Hospital
🇨🇳Nanjing City, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai City, China
Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center
🇨🇳Wuhan, China
General Hospital of Chinese PLA; Department of Hematology
🇨🇳Beijing, China
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
🇮🇹Milano, Lombardia, Italy
Azienda Ospedaliera Universitaria di Modena
🇮🇹Modena, Emilia-Romagna, Italy
Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia
🇮🇹Rozzano, Lombardia, Italy
Ospedale V. Cervello; U.O. Ematologia E Trapianti
🇮🇹Palermo, Sicilia, Italy
Uni Degli Studi; Dip.Med.Clinica E Sperim. Ematologia
🇮🇹Padova, Veneto, Italy
Sahlgrenska Universitetssjukhuset; Sektionen för hematologi och koagulation
🇸🇪Göteborg, Sweden
MT Cancer Inst Fndtn; MT Can Spec
🇺🇸Missoula, Montana, United States
A.O. Univ.Ospedali Riuniti Umerto I -G.M.Lancisi G.Salesi; U.O. Clinica Di Ematologia
🇮🇹Torrette DI Ancona, Marche, Italy
Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
🇨🇳Taipei City, Taiwan
Kumamoto University Hospital; Hematology Rheumatology and Clinical Immunology
🇯🇵Kumamoto, Japan
Toranomon Hospital; Hematology
🇯🇵Tokyo, Japan
Shinshu University Hospital; Hematology
🇯🇵Nagano, Japan
Matsushita Memorial Hospital; hematology
🇯🇵Osaka, Japan
Royal Bournemouth General Hospital; Haematology
🇬🇧Bournemouth, United Kingdom
St Bartholomew's Hospital
🇬🇧London, United Kingdom
Kent & Canterbury Hospital; Clinical Haematology
🇬🇧Canterbury, United Kingdom
Christie Hospital; Breast Cancer Research Office
🇬🇧Manchester, United Kingdom
St. George'S Hospital; Haematology
🇬🇧London, United Kingdom
Hammersmith Hospital; Haematology
🇬🇧London, United Kingdom
Nottingham City Hospital; Dept of Haematology
🇬🇧Nottingham, United Kingdom
Norfolk & Norwich Hospital; Dept of Haematology
🇬🇧Norwich, United Kingdom
Churchill Hospital; Oxford Cancer and Haematology Centre
🇬🇧Oxford, United Kingdom
Queen Alexandra Hospital; Haematology and Oncology Centre
🇬🇧Portsmouth, United Kingdom
Toronto East General Hospital; Haematology/Oncology
🇨🇦Toronto, Ontario, Canada
Helios Dr. Horst Schmidt Kliniken; Klinik Innere MED III: Hämatologie, Onkologie, Palliativmedizin
🇩🇪Wiesbaden, Germany
Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika
🇨🇿Brno, Czechia
Princess Alexandra Hospital; Department of Haematology
🇬🇧Harlow, United Kingdom
Castle Hill Hospital; The Queens Centre for Oncology and Haematology
🇬🇧Cottingham, United Kingdom
Western General Hospital; Department of Haematology
🇬🇧Edinburgh, United Kingdom
James Paget Hospital; Haematology Department
🇬🇧Great Yarmouth, United Kingdom
Southampton General Hospital; Medical Oncology
🇬🇧Southampton, United Kingdom
Royal Cornwall Hospital; Haematology Clinic
🇬🇧Truro, United Kingdom
Kootenai Cancer Center
🇺🇸Post Falls, Idaho, United States
The Regents of the University of California; Office of Research
🇺🇸Irvine, California, United States
Illinois Cancer Care, P.C. - Galesburg
🇺🇸Galesburg, Illinois, United States
Siouxland Hematology/Oncology
🇺🇸Sioux City, Iowa, United States
University of Kansas; Medical Center & Medical pavilion
🇺🇸Westwood, Kansas, United States
Mercy Medical Research Institute
🇺🇸Springfield, Missouri, United States
San Juan Oncology Associates
🇺🇸Farmington, New Mexico, United States
Concord Repatriation General Hospital; Haematology
🇦🇺Sydney, New South Wales, Australia
Westmead Hospital; Haematology
🇦🇺Sydney, New South Wales, Australia
Northwest Medical Specialties
🇺🇸Tacoma, Washington, United States
Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology
🇦🇺Woolloongabba, Queensland, Australia
Peter MacCallum Cancer Centre; Department of Haematology
🇦🇺Melbourne, Victoria, Australia
Austin and Repatriation Medical Centre; Cancer Services
🇦🇺Melbourne, Victoria, Australia
Monash Medical Centre; Haematology
🇦🇺Melbourne, Victoria, Australia
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
UZ Leuven Gasthuisberg
🇧🇪Leuven, Belgium
Tom Baker Cancer Centre-Calgary
🇨🇦Calgary, Alberta, Canada
Dr. Georges L. Dumont University Hospital Centre
🇨🇦Moncton, New Brunswick, Canada
Hopital Charles Lemoyne; Centre Integre de Lutte Contre Le Cancer de La Monteregie
🇨🇦Greenfield Park, Quebec, Canada
Beijing Cancer Hospital
🇨🇳Beijing, China
Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)
🇨🇳Shanghai, China
Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK
🇨🇿Praha 2, Czechia
Hotel Dieu; Medecine D
🇫🇷Angers, France
Helsinki University Central Hospital; Dept of Oncology
🇫🇮Helsinki, Finland
Fn Hr. Kralove; IV. Interni Hematologicka Klinika
🇨🇿Hradec Kralove, Czechia
Hopital Augustin Morvan; Hematologie
🇫🇷Brest, France
Chu Estaing; Hematologie Clinique Adultes
🇫🇷Clermont Ferrand, France
Hopital Saint Jean; Hematologie
🇫🇷Perpignan, France
Onkologischer Schwerpunkt am Oskar-Helene-Heim; Dres. Herrenberger, Keitel-Wittig u. Kirsch
🇩🇪Berlin, Germany
BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie
🇩🇪Dresden, Germany
Hopital Saint Eloi; Hematologie Oncologie Medicale
🇫🇷Montpellier, France
Städtisches Klinikum Dessau
🇩🇪Dessau-Roßlau, Germany
Klinikum Chemnitz gGmbH Krankenhaus Küchwald Klinik f.Innere Medizin III
🇩🇪Chemnitz, Germany
Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung
🇩🇪Essen, Germany
Gemeinschaftspraxis Dr. med. J. Mohm und Dr. med. G. Prange-Krex; Fachaerzte fuer Innere Medizin
🇩🇪Dresden, Germany
HELIOS Klinikum Erfurt I.Medizinische Klinik
🇩🇪Erfurt, Germany
St.-Antonius-Hospital gGmbH; Klinik für Hämatologie und Onkologie
🇩🇪Eschweiler, Germany
Universitätsklinikum Freiburg; Klinik für Innere Medizin I; Hämatologie/Onkologie
🇩🇪Freiburg, Germany
Uni Göttingen, Georg-August-Universität; Klinik für Hämatologie und Medizinische Onkologie
🇩🇪Göttingen, Germany
Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik
🇩🇪Greifswald, Germany
Kath. Krankenhaus Hagen gem. GmbH, St.-Josefs-Hospital; Klinik für Hämatologie und Onkologie
🇩🇪Hagen, Germany
Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V
🇩🇪Heidelberg, Germany
Onkologische Schwerpunktpraxis Dres. Bernd Gaede, Hans-Ulrich Ehlers, Ulrike Rodewig u.w.
🇩🇪Hannover, Germany
Universitätsklinikum Jena; Klinik für Innere Medizin II
🇩🇪Jena, Germany
Dres.Andreas Karcher und Stefan Fuxius
🇩🇪Heidelberg, Germany
Universitaetsklinikum des Saarlandes; medizinische Klinik und Poliklinik; Innere Medizin I
🇩🇪Homburg/Saar, Germany
Institut für Versorgungsforschung in der Onkologie GbR Koblenz
🇩🇪Koblenz, Germany
Klinik der Uni zu Köln; Klinik für Innere Medizin
🇩🇪Köln, Germany
Tagesklinik Landshut; Hämatologie/Onkologie
🇩🇪Landshut, Germany
Klinikum St.Georg gGmbH Klinik für Internistische Onkologie und Hämotologie
🇩🇪Leipzig, Germany
Onkologische Gemeinschaftspraxis
🇩🇪Magdeburg, Germany
Klinikum der Stadt Ludwigshafen; Medizinische Klinik A
🇩🇪Ludwigshafen, Germany
Gemeinschaftspraxis für Hämatologie und Onkologie
🇩🇪Lebach, Germany
St. Frankziskus Krankenhaus, Med. Klinik I; Klinik für Hämatologie,Onkologie u. Gastroenterologie
🇩🇪Mönchengladbach, Germany
Uni. der Johannes Gutenberg-Universitaet Mainz; III. Medizinische Klinik und Poliklinik
🇩🇪Mainz, Germany
Kliniken Ostalb, Stauferklinikum Schwäbisch-Gmünd; Zentrum für Innere Medizin
🇩🇪Mutlangen, Germany
Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III
🇩🇪München, Germany
Universität Tübingen; Med. Klinik; Innere Medizin I
🇩🇪Tübingen, Germany
Praxis für Hämatologie & Onkologie
🇩🇪Saarbruecken, Germany
Hospital Univ. 12 de Octubre; Servicio de Hematologia
🇪🇸Madrid, Spain
Shikoku Cancer Center; Hematology and Oncology
🇯🇵Ehime, Japan
Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora
🇮🇹Milano, Lombardia, Italy
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital; Hematology & Oncology
🇯🇵Aichi, Japan
Tokai University Hospital; Hematology
🇯🇵Kanagawa, Japan
University Hospital, Kyoto Prefectural University of Medicine; Hematology
🇯🇵Kyoto, Japan
National Cancer Center Hospital; Hematology
🇯🇵Tokyo, Japan
Fundacion Hospital de Alcorcon; Servicio de Hematologia
🇪🇸Alcorcon, Madrid, Spain
Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology
🇨🇳Taoyuan, Taiwan
Addenbrookes Hospital; Haematology
🇬🇧Cambridge, United Kingdom
St James Uni Hospital; Icrf Cancer Medicine Research Unit
🇬🇧Leeds, United Kingdom
King'S College Hospital; Haematology
🇬🇧London, United Kingdom
Leicester Royal Infirmary; Dept of Haematology
🇬🇧Leicester, United Kingdom
University College Hospital; Macmillan Cancer Centre
🇬🇧London, United Kingdom
Royal Marsden Hospital; Dept of Medical Oncology
🇬🇧Sutton, United Kingdom
Great Western;Department of Haematology
🇬🇧Swindon, United Kingdom
Highlands Oncology Group
🇺🇸Springdale, Arkansas, United States
Cancer Center of Kansas
🇺🇸Wichita, Kansas, United States
AZ Groeninge
🇧🇪Kortrijk, Belgium
Providence St. Vincent Medical Center
🇺🇸Portland, Oregon, United States
Jiangsu Province Hospital
🇨🇳Nanjing, China
Peking University First Hospital
🇨🇳Beijing City, China