An Efficacy and Safety Study Of Pracinostat In Combination With Azacitidine In Adults With Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT03151408|
Recruitment Status : Terminated (The IDMC recommended to stop the study prematurely due to a lack of efficacy.)
First Posted : May 12, 2017
Results First Posted : March 10, 2022
Last Update Posted : March 10, 2022
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Drug: Pracinostat Drug: Placebos Drug: Azacitidine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||406 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase III, Double-Blind, Placebo-Controlled, Multicenter, Randomized Study Of Pracinostat In Combination With Azacitidine In Patients ≥18 Years With Newly Diagnosed Acute Myeloid Leukemia Unfit For Standard Induction Chemotherapy|
|Actual Study Start Date :||June 23, 2017|
|Actual Primary Completion Date :||August 20, 2020|
|Actual Study Completion Date :||August 20, 2020|
Experimental: Pracinostat plus AZA
60 mg capsule orally, once a day, 3 times a week for 3 weeks, followed by 1 week of rest of each 28-day cycle. As a background therapy azacitidine (AZA) will be administered at a dose of 75 mg/m2 by SC or IV injection daily for 7 days of each 28-day cycle.
60 mg capsule
Other Name: SB939
SC or IV injection
Other Name: AZA
Placebo Comparator: Placebo plus AZA
1 capsule orally, once a day, 3 times a week for 3 weeks, followed by 1 week of rest of each 28-day cycle. As a background therapy azacitidine (AZA) will be administered at a dose of 75 mg/m2 by SC or IV injection daily for 7 days of each 28-day cycle.
SC or IV injection
Other Name: AZA
- Overall Survival [ Time Frame: 826 days ]OS measures the time from randomization to death due to any cause.
- Morphologic Complete Remission (CR) Rate [ Time Frame: 744 days ]
The CR rate is the proportion of patients who achieve a morphologic CR according to the response criteria
- <5% blasts in a bone marrow aspirate sample with spicules
- There should be no blasts with Auer rods
- No EMD
- Absolute Neutrophil Count (ANC) ≥1,000/μL
- Platelet count of ≥100,000/μL
- Patient must be independent of transfusions (for at least 1week before each assessment)
- Complete Remission Without Minimal Residual Disease (CRmrd) Rate [ Time Frame: 826 days ]
proportion of patients who achieve a CR without minimal residual disease by multicolor flow cytometry according to the following criteria
- Morphologic CR
- Minimal Residual Disease (MRD) by MFC negative
- Cytogenetic Complete Remission (CRc) Rate [ Time Frame: 826 days ]
The CRc rate is the proportion of patients who achieve a reversion to a normal karyotype at CR within the study period. This endpoint applies only to patients with abnormal cytogenetic at enrollment according to the following criterion
Morphologic CR plus reversion to a normal karyotype (defined as no clonal abnormalities detected in a minimum of 20 mitotic cells)
- Transfusion Independence (TI) [ Time Frame: 826 days ]Transfusion independence rate is defined as the proportion of patients who show eight weeks or over without red blood cell (RBC-TI) and/or platelet (PLT-TI) transfusion during study period
- Composite Complete Remission (cCR) Rate [ Time Frame: 744 days ]Composite complete remission (cCR) rate is the proportion of patients who achieve either a disease response of CR, CRi or MLFS (i.e., cCR = CR + CRi + MLFS) within the study period, according to the response criteria
- Duration of Composite Complete Remission [ Time Frame: 744 days ]Duration of cCR response is the time from first cCR until documented relapse (the definition of relapse from CR will be applied) or death. Duration of cCR is only defined for patients who achieve a cCR
- Change in Quality of Life From Baseline (EORTC QLQ-C30 - European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30) [ Time Frame: from baseline up to 660 days ]QLQ-C30 is made of multi-item scales and single-item measures (functional and symptom scales, a global health status/QoL scale and single items). Item range is the difference between possible max and min response to individual items of the scale; most items take values from 1 to 4 (range=3). Global health status takes values from 1 to 7 (range = 6). For statistical analysis purpose, single-item and scale values were all standardized (according to linear transformation described in Scoring Manual) to obtain scores ranging 0-100. An high scale score represents an higher response level. Thus an high score for a functional scale represents an high/healthy level of functioning, an high score for the global health status/QoL represents a high QoL, an high score for a symptom scale/item represents an high level of symptomatology/problems.
- Relapse Free Survival [ Time Frame: 744 days ]the time from the date of achievement of CR or CRi until the date of relapse or death from any cause
- Progressive Free Survival Rate (PFS) [ Time Frame: 800 days ]PFS is defined as the time from the date of randomization until the date of relapse (progression), or death from any cause, whichever occurs first.
- Duration of Morphologic CR [ Time Frame: 744 days ]Duration of morphologic CR is defined as the time from the date of achievement of CR until the date of relapse (progression).
- Time to CR [ Time Frame: 616 days ]Time to CR is defined as the time from the date of randomization until the date of CR in the absence of interceding therapies. The analysis set was the ITT set.
- Morphologic CR Within 6 Cycles Rate [ Time Frame: within 6 cycles ]Morphologic CR within 6 cycles rate is defined as the proportion of patients who achieved CR in the absence of interceding therapies within 6 treatment cycles (i.e., during treatment phase up to Day 1 of Cycle 7 included). Analysis was performed in the ITT set.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03151408
|Study Chair:||Guillermo Garcia-Manero, MD||MD Anderson|