Trial of CPX-351 in Adult Patients With First Relapse Acute Myeloid Leukemia (AML)
|ClinicalTrials.gov Identifier: NCT00822094|
Recruitment Status : Completed
First Posted : January 14, 2009
Results First Posted : September 29, 2017
Last Update Posted : November 24, 2017
The study investigates if CPX-351 will be a) more effective than the standard intensive salvage AML treatment and b) more tolerable than the standard intensive salvage treatment regimens.
The study compares the investigational product CPX-351 vs the standard intensive salvage treatment for first relapse AML patients.
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Drug: CPX-351 Drug: Intensive Salvage Therapy||Phase 2|
This study is a randomized, open-label, parallel-arm, fixed-dose, standard therapy controlled Phase IIB trial. Study enrollment duration is expected to be approximately 12-18 months. On entry, patients are randomized to receive either CPX-351 or intensive first salvage treatment.
Patients are stratified to balance the likelihood of obtaining a CR and the duration of CR between the two arms.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase IIB, Multicenter, Randomized, Open-Label Trial Of CPX-351 (Cytarabine : Daunorubicin) Liposome Injection Versus Intensive Salvage Therapy In Adult Patients ≤ 65 Years Old With AML In First Relapse Following An Initial CR > 1 Month Duration|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||January 2012|
Experimental: CPX-351 (Arm A)
First induction: 100 units/m2 on Days 1, 3, and 5 by 90-minute IV infusion Second induction: 100 units/m2 on Days 1 and 3 by 90-minute IV infusion Consolidation(s): 100 units/m2 on Days 1 and 3 by 90-minute IV infusion
Active Comparator: Salvage Therapy (Arm B)
First induction: Investigator's choice salvage therapy administered according to local practice Second induction: Investigator's choice salvage therapy administered according to local practice Consolidation(s): Investigator's choice consolidation therapy administered according to local practice
|Drug: Intensive Salvage Therapy|
- Proportion of Subjects Surviving at 1 Year [ Time Frame: Up to 1 year from randomization ]The proportion of subjects surviving at 1 year was evaluated separately for each arm by the number of subjects alive at 1 year divided by the total number of subjects.
- Complete Remission Rate [ Time Frame: Following 1st induction, following 2nd induction if applicable ]
- Event Free Survival [ Time Frame: Up to 1 year from randomization ]Progression EFS median
- Remission Duration [ Time Frame: Following achievement of CR and up to 1 year from randomization ]Remission duration was measured from the time the criteria for CR were first met until the first date that disease relapse was objectively documented or until subject death.
- Rate of Aplasia [ Time Frame: Up to 1 year from randomization ]Patients with Aplasia During Study
- Rate of Stem Cell Transplant [ Time Frame: Up to 1 year from randomization ]Number of patients transferred for stem cell transplant
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00822094
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|Principal Investigator:||Jonathan Kolitz, MD||North Shore University Hospital|