A Study of Idasanutlin With Cytarabine Versus Cytarabine Plus Placebo in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML)
- Conditions
- Leukemia, Myeloid, Acute
- Interventions
- Registration Number
- NCT02545283
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This is a multicenter, double-blind, randomized, placebo-controlled study designed to compare overall survival in participants with relapsed or refractory AML treated with idasanutlin in combination with cytarabine versus participants treated with placebo and cytarabine. Participants will receive induction treatment with idasanutlin/placebo and cytarabine (Cycle 1). Responding participants may continue to receive a maximum of further two cycles of consolidation (Cycle 2 and Cycle 3). Complete remission (CR), CR with incomplete platelet count recovery (CRp), overall remission rate (ORR), event-free survival (EFS) and percentage of participants with an allogeneic hematopoietic stem cell transplant (HSCT) will also be compared between treatment arms. This study will include participants with and without TP53 wild type (TP53 WT) mutations.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 447
- Documented/confirmed first/second refractory/relapsed AML using World Health Organization classification, except acute promyelocytic leukemia
- No more than 2 prior induction regimens (excluding prior HSCT) in their first line treatment and one must have included cytarabine with an anthracycline (or anthracenedione)
- Eastern Cooperative Oncology Group performance status of 0 to 2
- Adequate hepatic and renal function
- White blood cell (WBC) count at randomization less than or equal to (</=) 50000 cells per cubic millimeter (/mm^3)
- First relapsed participants aged less than (<) 60 years with first CR duration greater than (>) 1 year
- Participants with prior documented antecedent hematological disorder (AHD)
- AML secondary to any prior chemotherapy unrelated to leukemia
- Participants who are either refractory to or relapsed within 90 days of receiving a regimen containing a cumulative dose of greater than or equal to (>/=) 18 g/m^2 of cytarabine
- Participants who have received allogeneic HSCT within 90 days prior to randomization
- Participants who have received immunosuppressive therapy for graft versus host disease or for engraftment syndrome after autologous stem cell transplantation within 2 weeks prior to randomization
- Prior treatment with an Murine Double Minute 2 (MDM2) antagonist
- Participants receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy within 30 days from first receipt of study drug
- Participants with a history of other malignancy within 5 years prior to screening except for malignancy that has been in remission without treatment for at least 2 years prior to randomization
- Participants who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
- Participants with extramedullary AML with no evidence of systemic involvement
- Pregnant or breastfeeding participants
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo plus Cytarabine Placebo Participants will receive induction therapy idasanutlin matching placebo and cytarabine for 5 days followed by 23 days of rest in Cycle 1 (treatment cycle length=28 days). Responding participants may continue with consolidation therapy for a maximum of 2 additional cycles including idasanutlin matching placebo and cytarabine for 5 days followed by 23 days of rest in each cycle (treatment cycle length=28 days). After each cycle, for participants achieving CRp or CRi, up to 28 additional days are allowed for blood count recovery, if needed. Idasanutlin plus Cytarabine Cytarabine Participants will receive induction therapy idasanutlin and cytarabine for 5 Days followed by 23 days of rest in Cycle 1 (treatment cycle length=28 days). Responding participants may continue with consolidation therapy for a maximum of 2 additional cycles including idasanutlin and cytarabine for 5 days followed by 23 days of rest in each cycle (treatment cycle length=28 days). After each cycle, for participants achieving CRp or complete remission with incomplete blood count recovery (CRi), up to 28 additional days are allowed for blood count recovery, if needed. Placebo plus Cytarabine Cytarabine Participants will receive induction therapy idasanutlin matching placebo and cytarabine for 5 days followed by 23 days of rest in Cycle 1 (treatment cycle length=28 days). Responding participants may continue with consolidation therapy for a maximum of 2 additional cycles including idasanutlin matching placebo and cytarabine for 5 days followed by 23 days of rest in each cycle (treatment cycle length=28 days). After each cycle, for participants achieving CRp or CRi, up to 28 additional days are allowed for blood count recovery, if needed. Idasanutlin plus Cytarabine Idasanutlin Participants will receive induction therapy idasanutlin and cytarabine for 5 Days followed by 23 days of rest in Cycle 1 (treatment cycle length=28 days). Responding participants may continue with consolidation therapy for a maximum of 2 additional cycles including idasanutlin and cytarabine for 5 days followed by 23 days of rest in each cycle (treatment cycle length=28 days). After each cycle, for participants achieving CRp or complete remission with incomplete blood count recovery (CRi), up to 28 additional days are allowed for blood count recovery, if needed.
- Primary Outcome Measures
Name Time Method Overall Survival in TP53 WT Population From randomization to death from any cause (up to approximately 4.5 years) P53 tumor protein Wild Type (TP53 WT) population's Overall Survival was compared in participants with relapsed or refractory (R/R) acute myeloid leukemia (AML) who had been randomized to idasanutlin in combination with cytarabine versus those who had been randomized to cytarabine and placebo.
The study was terminated because of futility, therefore did not reach the planned end of the study.
- Secondary Outcome Measures
Name Time Method Percentage of Participants in Complete Response (CR) at the End of Induction According to Hematologic Malignancy Response Assessment (HMRA) in TP53 WT Population At the end of induction (up to Day 56) Rate of complete response at the end of induction in the TP53 WT population was compared in participants who had been randomized to idasanutlin in combination with cytarabine versus those who had been randomized to cytarabine and placebo.
The design followed a hierarchical statistical testing framework.Event-Free Survival (EFS) According to HMRA in TP53 WT Population From randomization up to treatment failure, relapse, or death from any cause (up to approximately 4.5 years) Event Free Survival (EFS) is defined as the time from the date of randomization to whichever occurs first: treatment failure (failure to achieve CR, set as day of final response assessment), relapse from CR, or death from any cause. The study was terminated because of futility, therefore did not reach the planned end of the study.
The design followed a hierarchical statistical testing framework.Percentage of Participants With Overall Remission (CR, CRp, and CRi) at the End of Induction According to HMRA in TP53 WT Population At the end of induction (up to Day 56) Rate of overall remission (complete remission, complete remission with incomplete hematologic recovery, complete remission with incomplete platelet count recovery) at the end of induction in the TP53 WT population was compared in participants who had been randomized to idasanutlin in combination with cytarabine versus those who had been randomized to cytarabine and placebo.
The design followed a hierarchical statistical testing framework.Duration of Remission Following CR (DOR) in TP53 WT Population From achieving CR until relapse or death from any cause (up to approximately 4.5 years) DOR is defined for patients achieving complete remission and is the time from clinical remission until relapse or death from any cause, whichever occurs first. For patients with none of these events before time of analysis, DOR is censored at the date of the patient's last response assessment.
The Median upper limits were set to 999 because they were not reached and therefore it was Not Evaluable (NE) and the field is numeric only. The study was terminated because of futility, therefore did not reach the planned end of the study.Percentage of Participants Undergoing HSCT Following Complete Response (CR), in TP53 WT Population Baseline up to approximately 4.5 years Rate of complete response at the end of induction in mutation-defined subgroups (positive for mutation of FLT3, IDH1 and IDH2, respectively) of the TP53 WT population was compared in participants who had been randomized to idasanutlin in combination with cytarabine versus those who had been randomized to cytarabine and placebo. The study was terminated because of futility, therefore did not reach the planned end of the study.
Percentage of Participants With Complete Response (CR) in Clinically Actionable Mutation-Defined Subpopulation (FLT3, IDH1 and IDH2) in TP53 WT Population At the end of induction (up to Day 56) Rate of complete response at the end of induction in mutation-defined subgroups (positive for mutation of FLT3, IDH1 and IDH2, respectively) of the TP53 WT population was compared in participants who had been randomized to idasanutlin in combination with cytarabine versus those who had been randomized to cytarabine and placebo.
Overall Survival in Clinically Actionable Mutation-Defined Subpopulation (FLT3, IDH1 and IDH2) in TP53 WT Population From randomization to death from any cause (up to approximately 4.5 years) Overall survival in mutation-defined subgroups (positive for mutation of FLT3, IDH1 and IDH2 respectively) of the TP53 WT population was compared in participants who had been randomized to idasanutlin in combination with cytarabine versus those who had been randomized to cytarabine and placebo. The Median upper limits were set to 999 because they were not reached and therefore it was Not Evaluable (NE) and the field is numeric only. The study was terminated because of futility, therefore did not reach the planned end of the study.
Number of Participants Who Experienced at Least One Adverse Event by Severity, According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.03 (NCI-CTCAE v4.03) Baseline up to approximately 4.5 years Participants who experienced at least one Adverse Event by severity, According to National Cancer Institute common terminology criteria for Adverse Events, version 4.03 (NCI-CTCAE v4.03) have been reported. The study was terminated because of futility, therefore did not reach the planned end of the study.
Number of Participants With Adverse Events Leading to Discontinuation Baseline up to approximately 4.5 years Participants with Adverse Events leading to discontinuation of the study have been reported. The study was terminated because of futility, therefore did not reach the planned end of the study.
Number of Participants With Adverse Events Leading to Death up to Day 30 Up to Day 30 The number of participants with AE resulted by death within 30 days from dosing is reported
Number of Participants With Adverse Events Leading to Death up to Day 60 Up to Day 60 The number of participants with AE resulted by death within 60 days from dosing is reported
Number of Participants With Clinical Laboratory Abnormalities in Biochemistry Tests at the Greatest Severity, According to NCI-CTCAE v4.03 Up to Approximately 4.5 Years Laboratory parameters for blood biochemistry will be measured and compared with a standard reference range. Values outside the standard reference range are considered abnormalities. A laboratory test result will be reported as an adverse event if it meets any of the following criteria: is accompanied by clinical symptoms; results in a change in study treatment or a medical intervention; or is clinically significant in the investigator's judgment.
For each patient, baseline is the last observation prior to initiation of study drug. For each laboratory test, patients with at least 1 post-baseline assessment are included in the analysis. For each cell, the denominator is the number of patients with baseline NCI-CTCAE Grade 0-2 in the specified direction of abnormality, or Grade 1-4 in the opposite direction of abnormality.Number of Participants With Clinical Laboratory Abnormalities in Hematology Tests at the Greatest Severity, According to NCI-CTCAE v4.03 Up to Approximately 4.5 Years Laboratory parameters for hematology will be measured and compared with a standard reference range. Values outside the standard reference range are considered abnormalities. A laboratory test result will be reported as an adverse event if it meets any of the following criteria: is accompanied by clinical symptoms; results in a change in study treatment or a medical intervention; or is clinically significant in the investigator's judgment.
For each patient, baseline is the last observation prior to initiation of study drug. For each laboratory test, patients with at least 1 post-baseline assessment are included in the analysis. For each cell, the denominator is the number of patients with baseline NCI-CTCAE Grade 0-2 in the specified direction of abnormality, or Grade 1-4 in the opposite direction of abnormality.Change From Baseline in Body Temperature Over Time Baseline; Cycles 1-3, Days 8, 15, 22, 28 (1 cycle is 28 days); and, if incomplete blood count recovery, Days 29-42 and Days 43-56, Cycles 2 -3 Days 1, 8, 15, 22, 28 and 29-56 (max delay between cycles is 56 days) Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
The study was terminated because of futility, therefore did not reach the planned end of study.Change From Baseline in Systolic Blood Pressure Over Time Baseline; Cycles 1-3, Days 8, 15, 22, 28 (1 cycle is 28 days); and, if incomplete blood count recovery, Days 29-42 and Days 43-56, Cycles 2 -3 Days 1, 8, 15, 22, 28 and 29-56 (max delay between cycles is 56 days) Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
The study was terminated because of futility, therefore did not reach the planned end of study.Change From Baseline in Diastolic Blood Pressure Over Time Baseline; Cycles 1-3, Days 8, 15, 22, 28 (1 cycle is 28 days); and, if incomplete blood count recovery, Days 29-42 and Days 43-56, Cycles 2 -3 Days 1, 8, 15, 22, 28 and 29-56 (max delay between cycles is 56 days) Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
The study was terminated because of futility, therefore did not reach the planned end of study.Change From Baseline in Pulse Rate Over Time Baseline; Cycles 1-3, Days 8, 15, 22, 28 (1 cycle is 28 days); and, if incomplete blood count recovery, Days 29-42 and Days 43-56, Cycles 2 -3 Days 1, 8, 15, 22, 28 and 29-56 (max delay between cycles is 56 days) Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
The study was terminated because of futility, therefore did not reach the planned end of study.Change From Baseline in Respiratory Rate Over Time Up to Approximately 4.5 Years Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
The study was terminated because of futility, therefore did not reach the planned end of study.Change From Baseline in Heart Rate, as Measured by Electrocardiogram Baseline; Cycles 1-3 Day 1 (2 hrs pre-dose, post-Cytarabine and 6 hrs post-Idasanutlin/Placebo ); Cycle 1-3 Day 2; Cycle 1 Day 5 (within 2 hrs Idanasanutlin/Placebo, post-Cytarabine and 6 hrs post-Idasanutlin/Placebo), Study Drug Completion Single 12-lead ECGs was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
The study was terminated because of futility, therefore did not reach the planned end of study.Apparent Clearance (CL/F) of Idasanutlin Cycle 1: Predose (0 hour [Hr]), end of 1-3 Hr cytarabine infusion, 6 Hr postdose on Days 1, 5; Predose (0 Hr) on Day 2; at Days 8, 10; Cycle 2, 3: predose (0 Hr) on Days 2, 5 (predose/postdose: relative to idasanutlin morning dose; cycle length= 28 days) Apparent Clearance (CL/F) of Idasanutlin was planned as part of the PK analyses. The Independent Data Monitoring Committee recommended stopping the study for futility based on a lack of OS benefit due to Hazard Ratio (HR) being greater than 1. The benefit-risk profile of idasanutlin combined with 1g/m2 cytarabine in fit R/R AML was not positive, as the observed marginal benefit does not outweigh the risks of idasanutlin in the relapsed or refractory AML population.
Therefore the study was prematurely terminated by the sponsor's decision and the result data did not derive.The benefit-risk profile of idasanutlin combined with 1g/m2 cytarabine in fit R/R AML was not positive, as the observed marginal benefit does not outweigh the risks of idasanutlin in the relapsed or refractory AML population. The planned CL/F did not derive for the result data and was not reported.Apparent Volume of Distribution (Vd/F) of Idasanutlin Cycle 1: Predose (0 Hr), end of 1-3 Hr cytarabine infusion, 6 Hr postdose on Days 1, 5; Predose (0 Hr) on Day 2; at Days 8, 10; Cycle 2, 3: predose (0 Hr) on Days 2, 5 (predose/postdose: relative to idasanutlin morning dose; cycle length= 28 days) Apparent Volume of Distribution (Vd/F) of Idasanutlin was planned as part of the PK analyses. The Independent Data Monitoring Committee recommended stopping the study for futility based on a lack of OS benefit due to Hazard Ratio (HR) being greater than 1. The benefit-risk profile of idasanutlin combined with 1g/m2 cytarabine in fit R/R AML was not positive, as the observed marginal benefit does not outweigh the risks of idasanutlin in the relapsed or refractory AML population.
Therefore the study was prematurely terminated by the sponsor's decision and the result data did not derive.Maximum Concentration Observed (Cmax) of Idasanutlin Cycle 1: Predose (0 Hr), end of 1-3 Hr cytarabine infusion, 6 Hr postdose on Days 1, 5; Predose (0 Hr) on Day 2; at Days 8, 10; Cycle 2, 3: predose (0 Hr) on Days 2, 5 (predose/postdose: relative to idasanutlin morning dose; cycle length= 28 days) Maximum Concentration Observed (Cmax) of Idasanutlin was planned as part of the PK analyses. The Independent Data Monitoring Committee recommended stopping the study for futility based on a lack of OS benefit due to Hazard Ratio (HR) being greater than 1. The benefit-risk profile of idasanutlin combined with 1g/m2 cytarabine in fit R/R AML was not positive, as the observed marginal benefit does not outweigh the risks of idasanutlin in the relapsed or refractory AML population.
Therefore the study was prematurely terminated by the sponsor's decision and the result data did not derive.Steady-State Concentration (Ctrough) of Idasanutlin Cycle 1: Predose (0 Hr), end of 1-3 Hr cytarabine infusion, 6 Hr postdose on Days 1, 5; Predose (0 Hr) on Day 2; at Days 8, 10; Cycle 2, 3: predose (0 Hr) on Days 2, 5 (predose/postdose: relative to idasanutlin morning dose; cycle length= 28 days) Steady-State Concentration (Ctrough) of Idasanutlin was planned as part of the PK analyses. The Independent Data Monitoring Committee recommended stopping the study for futility based on a lack of OS benefit due to Hazard Ratio (HR) being greater than 1. The benefit-risk profile of idasanutlin combined with 1g/m2 cytarabine in fit R/R AML was not positive, as the observed marginal benefit does not outweigh the risks of idasanutlin in the relapsed or refractory AML population.
Therefore the study was prematurely terminated by the sponsor's decision and the result data did not derive.Area Under the Concentration-Time Curve (AUC) During One Dosing Interval (AUCtau) of Idasanutlin Cycle 1: Predose (0 Hr), end of 1-3 Hr cytarabine infusion, 6 Hr postdose on Days 1, 5; Predose (0 Hr) on Day 2; at Days 8, 10; Cycle 2, 3: predose (0 Hr) on Days 2, 5 (predose/postdose: relative to idasanutlin morning dose; cycle length= 28 days) Area Under the Concentration-Time Curve (AUC) During One Dosing Interval (AUCtau) of Idasanutlin was planned as part of the PK analyses. The Independent Data Monitoring Committee recommended stopping the study for futility based on a lack of OS benefit due to Hazard Ratio (HR) being greater than 1. The benefit-risk profile of idasanutlin combined with 1g/m2 cytarabine in fit R/R AML was not positive, as the observed marginal benefit does not outweigh the risks of idasanutlin in the relapsed or refractory AML population.
Therefore the study was prematurely terminated by the sponsor's decision and the result data did not derive.Change From Baseline in Electrocardiogram Parameters: PQ, PR, RR, QRS, QT and QTcF Intervals Baseline, Days 1, 2, and 5 of Cycle 1, Days 1, 2 of Cycles 2 and 3 (1 cycle is 28 days), Treatment Discontinuation Visit (28 days after last dose of study drug) Single 12-lead ECGs was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
The study was terminated because of futility, therefore did not reach the planned end of study.Total Duration of Study Treatment Up to 3 cycles (1 cycle is 28 days) Participants were planned to be treated up to 3 Cycles.
Number of Treatment Cycles Started Up to 3 cycles (1 cycle is 28 days) Participants who started the study treatment cycles are reported.
Cumulative Dose of Idasanutlin and Cytarabine Up to 3 cycles (1 cycle is 28 days) The cumulative doses of idasanutlin and cytaradine are reported.
AUC From Time Zero to 24 Hours Post Dose (AUC0-24) of Idasanutlin Cycle 1: Predose (0 Hr), end of 1-3 Hr cytarabine infusion, 6 Hr postdose on Days 1, 5; Predose (0 Hr) on Day 2; at Days 8, 10; Cycle 2, 3: predose (0 Hr) on Days 2, 5 (predose/postdose: relative to idasanutlin morning dose; cycle length= 28 days) AUC from Time Zero to 24 Hours Post Dose (AUC0-24) of Idasanutlin was planned as part of the PK analyses. The Independent Data Monitoring Committee recommended stopping the study for futility based on a lack of OS benefit due to Hazard Ratio (HR) being greater than 1. The benefit-risk profile of idasanutlin combined with 1g/m2 cytarabine in fit R/R AML was not positive, as the observed marginal benefit does not outweigh the risks of idasanutlin in the relapsed or refractory AML population.
Therefore the study was prematurely terminated by the sponsor's decision and the result data did not derive.Half-Life (t 1/2) of Idasanutlin Cycle 1: Predose (0 Hr), end of 1-3 Hr cytarabine infusion, 6 Hr postdose on Days 1, 5; Predose (0 Hr) on Day 2; at Days 8, 10; Cycle 2, 3: predose (0 Hr) on Days 2, 5 (predose/postdose: relative to idasanutlin morning dose; cycle length= 28 days) Half-Life (t 1/2) of Idasanutlin was planned as part of the PK analyses. The Independent Data Monitoring Committee recommended stopping the study for futility based on a lack of OS benefit due to Hazard Ratio (HR) being greater than 1. The benefit-risk profile of idasanutlin combined with 1g/m2 cytarabine in fit R/R AML was not positive, as the observed marginal benefit does not outweigh the risks of idasanutlin in the relapsed or refractory AML population.
Therefore the study was prematurely terminated by the sponsor's decision and the result data did not derive.Total Clearance (CL) of Cytarabine Cycle 1: Within 2 Hr pre-cytarabine dose, end of 1-3 Hr cytarabine infusion, 6 Hr post idasanutlin morning dose on Days 1, 5; Within 2 Hr pre-cytarabine dose on Day 2; Cycle 2, 3: Within 2 Hr pre-cytarabine dose on Day 2 (Cycle length= 28 days) The Total Clearance (CL) of Cytarabine was planned as part of the PK analyses. The Independent Data Monitoring Committee recommended stopping the study for futility based on a lack of OS benefit due to Hazard Ratio (HR) being greater than 1. The benefit-risk profile of idasanutlin combined with 1g/m2 cytarabine in fit R/R AML was not positive, as the observed marginal benefit does not outweigh the risks of idasanutlin in the relapsed or refractory AML population.
Therefore the study was prematurely terminated by the sponsor's decision and the result data did not derive.Volume of Distribution (Vd) of Cytarabine Cycle 1: Within 2 Hr pre-cytarabine dose, end of 1-3 Hr cytarabine infusion, 6 Hr post idasanutlin morning dose on Days 1, 5; Within 2 Hr pre-cytarabine dose on Day 2; Cycle 2, 3: Within 2 Hr pre-cytarabine dose on Day 2 (Cycle length= 28 days) The Volume of Distribution (Vd) of Cytarabine was planned as part of the PK analyses. The Independent Data Monitoring Committee recommended stopping the study for futility based on a lack of OS benefit due to Hazard Ratio (HR) being greater than 1. The benefit-risk profile of idasanutlin combined with 1g/m2 cytarabine in fit R/R AML was not positive, as the observed marginal benefit does not outweigh the risks of idasanutlin in the relapsed or refractory AML population.
Therefore the study was prematurely terminated by the sponsor's decision and the result data did not derive.Change From Baseline in European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score Cycle 1 Day 1 (Baseline), Days 8, 15, 28 of Cycle 1, Days 1, 8, 15, 28 of Cycles 2, 3, 28 days after last dose (last dose on Cycle 3 Day 5), thereafter every 3 months until relapse (maximum up to 3.5 years) The compliance rate (defined as the number of patients who completed as least 1 question on the measure) at baseline was 56% and 61% for the Idasanutlin arm and the placebo arm, respectively. This compliance rate remained the same post-baseline in both arms. Due to the low compliance rates in both arms during the entire treatment period, the planned analyses were not performed.
Change From Baseline in EuroQol 5 Dimension 5-Level (EQ-5D-5L) Questionnaire Score Cycle 1 Day 1 (Baseline), Days 8, 15, 28 of Cycle 1, Days 1, 8, 15, 28 of Cycles 2, 3, 28 days after last dose (last dose on Cycle 3 Day 5), thereafter every 3 months until relapse (maximum up to 3.5 years) The compliance rate (defined as the number of patients who completed as least 1 question on the measure) at baseline was 56% and 61% for the Idasanutlin arm and the placebo arm, respectively. Compliance remained the same post-baseline in both arms Due to the low compliance rates in both arms during the entire treatment period, the planned analyses were not performed.
Trial Locations
- Locations (82)
Hopital Claude Huriez; Hematologie
🇫🇷Lille, France
Institut J Paoli I Calmettes; Onco Hematologie 2
🇫🇷Marseille, France
Hopital Saint Louis; Oncologie Medicale
🇫🇷Paris, France
HOPITAL SAINT ANTOINE;Hematologie Clinique
🇫🇷Paris, France
IUCT Oncopole; Hematologie
🇫🇷Toulouse, France
A.O. Universitaria San Luigi Gonzaga di Orbassano; Ambulatorio per le Malattie Rare del Polmone
🇮🇹Orbassano (TO), Piemonte, Italy
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Chonnam National University Hwasun Hospital
🇰🇷Jeollanam-do, Korea, Republic of
St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta
🇷🇺Saint-Petersburg, Russian Federation
Az. Osp. S. Orsola Malpighi; Istituto Di Oncologia Seragnoli
🇮🇹Bologna, Emilia-Romagna, Italy
Universitätsspital Basel; Hämatologie
🇨🇭Basel, Switzerland
Hopital De Haut Leveque; Hematologie Clinique
🇫🇷Pessac, France
Centre Hospitalier Lyon Sud; Hematolgie
🇫🇷Pierre Benite, France
Hopitaux De Brabois; Hematologie Medecine Interne
🇫🇷Vandoeuvre Les Nancy, France
Canberra Hospital; Haematology Department
🇦🇺Canberra, Australian Capital Territory, Australia
Lkh-Univ. Klinikum Graz; Klin. Abt. Für Hämatologie
🇦🇹Graz, Austria
Centre Hospitalier Uni Ire; Service Des Maladies Du Sang
🇫🇷Angers Cedex 9, France
Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik und Poliklinik I
🇩🇪Dresden, Germany
Geelong Hospital; Andrew Love Cancer Centre
🇦🇺Geelong, Victoria, Australia
Alfred Hospital; Clinical Haematology and Bone Marrow Transplantation
🇦🇺Melbourne, Victoria, Australia
Uniklinik RWTH Aachen; Klinik IV; Klinik Hämatologie, Onkologie, Hämostaseologie und Stamm.
🇩🇪Aachen, Germany
Medizinische Hochschule Hannover; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie
🇩🇪Hannover, Germany
Klinik der Uni zu Köln; I. Med. Klinik
🇩🇪Köln, Germany
IRCCS AOU S.Martino; Clinica Ematologica
🇮🇹Genova, Liguria, Italy
A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia
🇮🇹Torino, Piemonte, Italy
Complejo Hospitalario Arnulfo Arias Madrid; Servicio de Hematología
🇵🇦Panama City, Panama
"Hematological Scientific Center
🇷🇺Moscow, Russian Federation
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST); Onco-Ematologia
🇮🇹Meldola, Emilia-Romagna, Italy
Ospedale Santa Chiara; Unita Operativa Di Ematologia
🇮🇹Pisa, Toscana, Italy
Auckland city hospital; Auckland Regional Cancer Centre and Blood Service
🇳🇿Auckland, New Zealand
FGBU "Federal Medical and Research Center named after V.A.Almazov" Russian Ministry of Health
🇷🇺Sankt-Petersburg, Russian Federation
Abramson Cancer Center; Univ of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
M.D. Anderson Cancer Center; Department of Hematology
🇺🇸Houston, Texas, United States
Concord Repatriation General Hospital; Haematology
🇦🇺Sydney, New South Wales, Australia
Rabin Medical Center-Beilinson Campus;Hematology-Oncology
🇮🇱Petach Tikva, Israel
Uni. der Johannes Gutenberg-Universitaet Mainz; III. Medizinische Klinik und Poliklinik
🇩🇪Mainz, Germany
Universitätsklinikum Marburg Zentrum f. Innere Medizin
🇩🇪Marburg, Germany
Shaare Zedek Medical Center; Hematology Dept.
🇮🇱Jerusalem, Israel
Hadassah Ein Karem Hospital; Haematology
🇮🇱Jerusalem, Israel
Ichilov Sourasky Medical Center; Heamatology
🇮🇱Tel Aviv, Israel
Ospedale Cardarelli; Divisione Di Ematologia
🇮🇹Napoli, Campania, Italy
A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Ematologica
🇮🇹Udine, Friuli-Venezia Giulia, Italy
Az. Osp. S. Maria Delle Croci; U.O. Di Ematologia
🇮🇹Ravenna, Emilia-Romagna, Italy
Az. Osp. Uni Ria Policlinico Tor Vergata; Unita Di Ematologia
🇮🇹Roma, Lazio, Italy
Ospedale San Raffaele, IRCCS
🇮🇹Milano, Lombardia, Italy
Academisch Medisch Centrum; Hematologie
🇳🇱Amsterdam, Netherlands
Haukeland Universitetssjukehus; Klinisk forskningspost
🇳🇴Bergen, Norway
Hospital Univ. 12 de Octubre; Servicio de Hematologia
🇪🇸Madrid, Spain
Birmingham Heartlands Hospital
🇬🇧Birmingham, United Kingdom
Universitätsspital Zürich Medizin Hämatologie; Klinik für Hämatologie
🇨🇭Zürich, Switzerland
Hospital Universitario la Fe; Servicio de Hematologia
🇪🇸Valencia, Spain
Christie Hospital NHS Trust
🇬🇧Manchester, United Kingdom
Royal Marsden NHS Foundation Trust
🇬🇧Sutton, United Kingdom
Northwell Health
🇺🇸Great Neck, New York, United States
New York Medical College
🇺🇸Hawthorne, New York, United States
Royal Adelaide Hospital; Haematology Clinical Trials
🇦🇺Adelaide, South Australia, Australia
AZ Delta (Campus Rumbeke)
🇧🇪Roeselare, Belgium
CH Jolimont - Lobbes (Jolimont)
🇧🇪Haine-Saint-Paul, Belgium
Juravinski Cancer Clinic; Clinical Trials Department
🇨🇦Hamilton, Ontario, Canada
Tampere University Hospital; Hematology
🇫🇮Tampere, Finland
Hopital Hotel Dieu Et Hme;Hopital De Jour
🇫🇷Nantes, France
Universitätsklinikum Bonn; Med. Klinik und Poliklinik III; Hämatologie, Onkologie und Rheumatologie
🇩🇪Bonn, Germany
Klinikum Braunschweig; Medizinische Klinik III; Klinik für Hämatologie und Onkologie
🇩🇪Braunschweig, Germany
Klinikum Chemnitz gGmbH Krankenhaus Küchwald Klinik f.Innere Medizin III
🇩🇪Chemnitz, Germany
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
🇮🇹Milano, Lombardia, Italy
Az. Osp. Di Careggi; Divisione Di Ematologia
🇮🇹Firenze, Toscana, Italy
ASST PAPA GIOVANNI XXIII; Ematologia
🇮🇹Bergamo, Lombardia, Italy
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul St Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Academisch Ziekenhuis Maastricht
🇳🇱Maastricht, Netherlands
Oslo Universitetssykehus HF, Rikshospitalet
🇳🇴Oslo, Norway
St Bartholomew's Hospital
🇬🇧London, United Kingdom
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
University Hospital of Wales
🇬🇧Cardiff, United Kingdom
Hospital de la Santa Creu i Sant Pau; Servicio de Hematologia
🇪🇸Barcelona, Spain
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
🇪🇸Barcelona, Spain
Ichan School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
CHU Sart-Tilman
🇧🇪Liège, Belgium
Helsinki University Central Hospital; Hematology
🇫🇮Helsinki, Finland
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States