Trial · NCT02088541
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks) | Overall survival was defined as the time (in days) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. |
| Secondary | Percentage of Participants With Overall Survival of at Least 3 Months (OS3.0) | From randomization (Day 1) up to 3 months | Overall survival was defined as the time (in days) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method. |
| Secondary | Percentage of Participants With Complete Remission Rate (CRR) for Those Who Achieved Complete Remission (CR) | Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks) | CRR was analyzed using International Working Group (IWG) 2003 criteria, as the difference in the proportions of participants with IWG results of CR. CR per IWG 2003 criteria was defined as morphologic presence of \< 5 percentage (%) myeloblasts in bone marrow, the absence of circulating blasts, hematologic recovery (as evidenced by a peripheral blood absolute neutrophil count (ANC) \> 1000 cells/microliter (microL) and platelet count \> 100,000/microL, with no need for red blood cell (RBC) transfusions), and the absence of extramedullary disease. |
| Secondary | Median Disease-Free Survival (DFS) for Participants Who Achieved Complete Remission (CR) | Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks) | DFS for CRR based on IWG criteria, was calculated from the first date of response of CR to the date of progression or recurrence, or date of death if progression or recurrence did not occur. Participants who discontinued prior to disease progression or recurrence or did not progress as of the time of the analysis were censored at the time of last radiologic assessment. CR per IWG 2003 criteria was defined as morphologic presence of \< 5 % myeloblasts in bone marrow, the absence of circulating blasts, hematologic recovery (as evidenced by a peripheral blood ANC \> 1000 cells/microL and platelet count \> 100,000/microL, with no need for RBC transfusions), and the absence of extramedullary disease. |
| Secondary | Percentage of Participants With Modified Complete Remission Rate (mCRR) for Those Who Achieved Complete Remission (CR) or Complete Remission With Incomplete Hematologic Recovery (Cri) | Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks) | mCRR was defined as the point estimate of the percentage of participants who had CR, CRi, or CRp. Responses defined as per IWG 2003 response criteria: Morphologic CR:\< 5% myeloblasts in bone marrow, the absence of circulating blasts, hematologic recovery (as evidenced by a peripheral blood ANC \> 1000 cells/microL and platelet count \> 100,000/microL, with no need for RBC transfusions), and the absence of extramedullary disease. Morphologic CRp: All criteria for CR except for residual neutropenia (\<1x10\^9/L) or thrombocytopenia (\<100 x10\^9/L), Cri (\< 5% bone marrow blasts with residual neutropenia \[ANC \< 1000 cells/microL\] or thrombocytopenia \[platelets \< 100,000/microL\]), normal maturation of all cellular components in the bone marrow, no extramedullary disease and transfusion independent. |
| Secondary | Median Disease-Free Survival (DFS) for Participants Who Achieved Complete Remission or CR With Incomplete Hematologic Recovery (CRi) or Complete Remission With Incomplete Platelet Recovery (CRp) | Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks) | DFS based on IWG criteria was defined as the duration from start of the complete response achieved until disease progression or death from any cause. Responses defined by IWG 2003 Response Criteria: Morphologic CR: \< 5% myeloblasts in bone marrow, the absence of circulating blasts, hematologic recovery (as evidenced by a peripheral blood ANC \> 1000 cells/microL and platelet count \> 100,000/microL, with no need for RBC transfusions), and the absence of extramedullary disease. Morphologic CRp: All criteria for CR except for residual neutropenia (\<1x10\^9/L) or thrombocytopenia (\<100 x10\^9/L), Cri (\< 5% bone marrow blasts with residual neutropenia \[ANC \< 1000 cells/microL\] or thrombocytopenia \[platelets \< 100,000/microL\]), normal maturation of all cellular components in the bone marrow, no extramedullary disease and transfusion independent. |
| Secondary | Percentage of Participants With Overall Response Rate (ORR) | Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks) | Overall response rate was defined as the point estimate of the percentage of participants who achieved CR (disappearance of all target and non-target lesions), partial response (PR) (\>=30 % decrease in sum of longest diameters of target lesions taking as reference baseline sum longest diameters associated to non-progressive disease response for non-target lesions). CRi; \< 5% BM blasts with residual neutropenia \[ANC \< 1000 cells/microL\] or thrombocytopenia \[platelets \< 100,000/microL\]. CRp; All criteria for CR except for residual neutropenia (\<1x10\^9/L) or thrombocytopenia (\<100 x10\^9/L) and morphologic leukemia-free state (MLFS); morphologic BM blast clearance to \<5% in a marrow sample in which \<=200 cells enumerated or cellularity is ≥10%, in absence of blasts with Auer rods, no hematologic recovery required. |
| Secondary | Duration of Response (DOR) | Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (up to a maximum of approximately 104 weeks) | DOR was calculated from date of response of CR, CRi, CRp, MLFS, or PR to date of progression or recurrence based on IWG criteria. CR: \<5% myeloblasts in bone marrow,absence of circulating blasts, hematologic recovery (peripheral blood ANC \>1000 cells/microL, platelet count \> 100,000/microL, no need for RBC transfusions), absence of extramedullary disease. PR: No circulating blasts, neutrophil count \> =1.0 x10\^9/L, platelet count \>= 100 x10\^9/L, \>= 50 % reduction in bone marrow blast to 6% to 25%, or blasts less than or equal to (\<=) 5% if Auer rods are present. CRp: All criteria for CR except for residual neutropenia (\<1x10\^9/L) or thrombocytopenia (\<100 x10\^9/L), CRi; \< 5% bone marrow blasts with residual neutropenia \[ANC \< 1000 cells/microL\] or thrombocytopenia \[platelets \< 100,000/microL\]. MLFS: morphologic bone marrow blast clearance to \< 5% in marrow sample, \<= 200 cells enumerated/cellularity is ≥ 10%, in absence of blasts with Auer rods, no hematologic recovery required. |
| Secondary | Percentage of Participants With Disease Control Rate (DCR) | Up to 4 weeks from the date of randomization to the date of progression or recurrence based on IWG criteria | DCR:Point estimate of % of participants with CR,CRi,CRp,MLFS,PR, or SD for \<=4 weeks.CR:\<5% myeloblasts in bone marrow (BM),absence of circulating blasts,hematologic recovery(peripheral blood ANC \>1000 cells/microL and platelet count \>100,000/microL, no need of RBC transfusions),absence of extramedullary disease. PR:No circulating blasts,Neutrophil count \>=1.0 x10\^9/L, Platelet count \>= 100\*10\^9/L, \>=50% reduction in BM blast to 6% to 25%, or blasts \<=5% if Auer rods are present.CRp:All criteria for CR except for residual neutropenia (\<1\*10\^9/L) or thrombocytopenia(\<100 x10\^9/L),CRi;\< 5% BM blasts with residual neutropenia \[ANC \< 1000 cells/microL\] or thrombocytopenia \[platelets \< 100,000/microL\]. MLFS:morphologic BM blast clearance to \<5% in a marrow sample in which \<=200 cells enumerated or cellularity is ≥10%,in absence of blasts with Auer rods,no hematologic recovery required,SD:failure to achieve a response but not meeting criteria for disease progression over period of \>4 weeks. |
| Secondary | Duration of Disease Control Rate | Up to 4 weeks from the date of randomization to the date of progression or recurrence based on IWG criteria | Duration of DCR calculated for all participants with DCR. CR: \< 5% myeloblasts in BM, absence of circulating blasts, hematologic recovery (peripheral blood ANC \>1000 cells/microL and platelet count \> 100,000/microL, no need for RBC transfusions), absence of extra medullary disease. PR: No circulating blasts, Neutrophil count \>=1.0 x 10\^9/L, Platelet count \>= 100 x 10\^9/L, \>= 50 % reduction in BM blast to 6% to 25%, or blasts \<= 5% if Auer rods are present. CRp: All criteria for CR except for residual neutropenia (\<1 x 10\^9/L) or thrombocytopenia (\<100 x 10\^9/L), CRi; \< 5% BM blasts with residual neutropenia \[ANC \< 1000 cells/microL\] or thrombocytopenia \[platelets \< 100,000/microL\]. MLFS; morphologic BM blast clearance to \< 5% in a marrow sample in which \<=200 cells enumerated/cellularity is \>= 10%, in absence of blasts with Auer rods, no hematologic recovery required and SD; failure to achieve a response but not meeting criteria for disease progression over period of \> 4 weeks. |
| Secondary | Change From Baseline in Quality of Life (QoL) and Patient-Reported Outcomes (Functional Assessment of Cancer Therapy -Leukemia [FACT-Leu] | Baseline, Day 1 of each treatment cycle (a maximum of 20 cycles: 28 days per cycle) up to 30 days after last dose of study drug (final visit) | QoL was assessed by the FACT-Leu. FACT-Leu combines the General version of the Functional Assessment of Cancer Therapy (FACT-G) with a leukemia-specific sub-scale (17 items). The sub-scales for the FACT-G are Physical Well-Being (7 items), Social/Family Well-Being (7 items), Emotional Well-Being (6 items), and Functional Well-Being (7 items). The trial outcomes index (TOI; total of 31 items) was the primary measurement of interest, comprising the Physical and Functional sub-scales plus the leukemia - specific sub-scale. Each item was rated on a 5-point Likert scale. Range from 0 = (Not at all) to 4 = (Very much); therefore, the TOI had a score ranging from 0 to 124. Higher scores indicated improvement in well being. The QoL assessment was performed at baseline (prior to first dose of study treatment), Day 1 of each cycle on or after the second, and at the final visit. |
| Secondary | Change From Baseline in European Quality of Life-5 Dimension (EQ-5D) Health Questionnaire Visual Analogue Scale (VAS) | Baseline, Day 1 of each treatment cycle (a maximum of 20 cycles: 28 days per cycle) up to 30 days after last dose of study drug (final visit) | EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ VAS. EQ-5D-5-VAS records participant's self-rated health on a vertical VAS that allows them to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable), higher scores indicating a better health state. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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