Trial of CPX-351 in Newly Diagnosed Elderly AML Patients
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|ClinicalTrials.gov Identifier: NCT00788892|
Recruitment Status : Completed
First Posted : November 11, 2008
Results First Posted : January 12, 2018
Last Update Posted : January 12, 2018
The study investigates if CPX-351 will be a) more effective than the standard AML treatment and b) more tolerable than the standard AML treatment regimens.
The study compares the investigational product CPX-351 vs the standard treatment for AML in this patients age group.
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Drug: CPX-351 Drug: Cytarabine Drug: Daunorubicin||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 standard induction treatment with cytarabine and daunorubicin("7 and 3" regimen).
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 Cytarabine and Daunorubicin in Patients With Untreated AML 60-75 Years of Age.|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||December 2011|
Experimental: Arm A: CPX-351
First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3
Active Comparator: Arm B: Cytarabine + Daunorubicin
First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice
|Drug: Cytarabine Drug: Daunorubicin|
- Number of Participants With Complete Remission [ Time Frame: Within 6 weeks of the last induction treatment ]Response was defined according to International Working Group Criteria (Cheson, et al. 2003) which requires peripheral blood neutrophils of >1000/µL and peripheral blood platelets of >100,000/µL in the absence of bone marrow blasts.
- Remission Duration/Time to Remission [ Time Frame: Following achievement of CR over the study period ]
Remission Duration was assessed from the time measurement criteria for CR were met until the first date that disease relapse was objectively documented or the subject died.
Time to remission was measured from the date of randomization to the time measurement criteria for CR were first met.
- Event Free Survival [ Time Frame: Up to 1 year from randomization ]Event-free survival begins from randomization to the date persistent disease is documented or date of relapse after CR, or death, whichever comes first.
- Overall Survival Rate at 1 Year [ Time Frame: 1 year ]Survival defined as the time from randomization to death.
- Rate of Stem Cell Transplant [ Time Frame: Up to 1 year ]The rate of patients who underwent stem cell transplant.
- Aplasia Rate [ Time Frame: Day 14 (1st Induction) ]Bone marrow aplasia was defined as <20% cellularity and 5% blasts in the bone marrow aspiration evaluation.
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): NCT00788892
Show 28 Study Locations
|Principal Investigator:||Jeffrey E Lancet, MD||H. Lee Moffitt Cancer Center|