Phase III Study of CPX-351 Versus 7+3 in Patients 60-75 Years Old With Untreated High Risk (Secondary) Acute Myeloid Leukemia (301)
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|ClinicalTrials.gov Identifier: NCT01696084|
Recruitment Status : Unknown
Verified January 2018 by Jazz Pharmaceuticals.
Recruitment status was: Active, not recruiting
First Posted : September 28, 2012
Results First Posted : October 2, 2017
Last Update Posted : February 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|High Risk Acute Myeloid Leukemia||Drug: CPX-351 Drug: 7+3 (cytarabine and daunorubicin)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||309 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase III, Multicenter, Randomized, Trial of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection Versus Cytarabine and Daunorubicin in Patients 60-75 Years of Age With Untreated High Risk (Secondary) AML|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||March 2016|
|Estimated Study Completion Date :||November 2019|
Experimental: Arm A (CPX-351)
Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.
First induction: 100 units/m2 by 90-minute IV infusion on Days 1, 3, 5. Second induction: 100 units/m2 by 90-minute IV infusion on Days 1 and 3. Consolidation therapy: 65 units/m2 by 90-minute IV infusion on Days 1 and 3.
Active Comparator: Arm B (7+3)
Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.
Drug: 7+3 (cytarabine and daunorubicin)
First induction: 7+3 was administered as: cytarabine at a dose of 100 mg/m2/day on Days 1 through 7 by continuous infusion, and daunorubicin at a dose of 60 mg/m2/day on Days 1, 2, and 3.
Second induction: 5+2 was administered as: cytarabine at a dose of 100 mg/m2/day on Days 1 through 5 by continuous infusion and daunorubicin at a dose of 60 mg/m2/day on Days 1 and 2.
Consolidation therapy: 5+2 was administered as: cytarabine at a dose of 100 mg/m2/day on Days 1 through 5 by continuous infusion, and daunorubicin at a dose of 60 mg/m2/day on Days 1 and 2.
Other Name: cytarabine and daunorubicin
- Overall Survival [ Time Frame: From the date of randomization to death from any cause ]Overall survival was measured from the date of randomization to death from any cause, subjects not known to have died by the last follow-up were censored on the date they were last known to be alive.
- Proportion of Subjects With a Response [ Time Frame: Post Induction ]Complete Remission (CR)
- Event-free Survival [ Time Frame: From the date of randomization to the date that persistent disease was documented or the date of relapse after CR or death, whichever came first ]All randomized subjects were assessed for event-free survival (EFS). EFS was defined as the time from study randomization to the date of induction treatment failure (persistent disease), relapse from CR or CRi or death from any cause, whichever came first. Subjects alive and not known to have any of these events were censored on thee date they were last examined on study.
- Remission Duration [ Time Frame: From the date of achievement of a remission until the date of relapse or death from any cause ]Only subjects achieving CR or CRi were assessed for remission duration.
- Rate of Achieving Morphologic Leukemia-free State [ Time Frame: Day 14 ]All randomized subjects with at least 1 evaluable postrandomization bone marrow assessment performed on or after Day 14 after the last induction were assessed for MLFS.
- Proportion of Subjects Receiving a Stem Cell Transplant [ Time Frame: Post Induction ]The number and percentage of subjects transferred for HSCT after induction treatment was recorded.
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): NCT01696084