Trial of CPX-351 in Adult Patients With First Relapse Acute Myeloid Leukemia (AML)
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.
|Acute Myeloid Leukemia||Drug: CPX-351 Drug: Intensive Salvage Therapy||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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|
- Percentage Overall Survival at 1 year [ Time Frame: Up to 1 year from randomization ]
- Complete Remission Rate [ Time Frame: Following 1st induction, following 2nd induction if applicable ]
- Event Free Survival [ Time Frame: Up to 1 year from randomization ]
- Complete Remission Duration [ Time Frame: Following achievement of CR and up to 1 year from randomization ]
- Rate of Aplasia [ Time Frame: Up to 1 year from randomization ]
- Rate of Stem Cell Transplant [ Time Frame: Up to 1 year from randomization ]
- Early induction mortality at day 30 and at day 60 from start of 1st induction [ Time Frame: day 30 and day 60 from 1st induction ]
- Late mortality [ Time Frame: following Day 90 from 1st induction ]
- Cardiac toxicity by monitoring of left ventricular ejection fraction changes [ Time Frame: Up to 1 year from randomization ]
|Study Start Date:||February 2009|
|Study Completion Date:||January 2012|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
100u/m2 will be administered on study days 1, 3 and 5 as a 90 minute infusion
Active Comparator: B
Investigators choice of an Intensive Salvage Therapy for remission induction (non-palliative) purposes (for example: "HiDAC" (high dose ara-d, anthracycline), "MEC" (mitoxantrone, etoposide, cytarabine), "7 + 3" (cytarabine, daunorubucin))
Drug: Intensive Salvage Therapy
Investigators choice of an Intensive Salvage Therapy as used for remission induction
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00822094
Show 42 Study Locations
|Principal Investigator:||Jonathan Kolitz, MD||North Shore University Hospital|