Trial of CPX-351 in Newly Diagnosed Elderly AML Patients
- Conditions
- Acute Myeloid Leukemia
- Interventions
- Registration Number
- NCT00788892
- Lead Sponsor
- Jazz Pharmaceuticals
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 126
- Age ≥60 and <76 years at the time of diagnosis of AML
- Pathological confirmation of AML
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Able to adhere to the study visit schedule and other protocol requirements
- Laboratory values fulfilling the following:
Serum creatinine < 2.0 mg/dL Serum total bilirubin < 2.0 mg/dL Serum alanine aminotransferase or aspartate aminotransferase < 150 IU/liter Note: If elevated liver enzymes are related to disease; contact medical monitor to discuss.
- Cardiac ejection fraction > 50% by echocardiography or MUGA scan
- Patients with locally advanced or metastatic solid tumors ≤5 years from initial diagnosis are excluded. (Patients with locally advanced or metastatic solid tumors >5 years from initial diagnosis, for whom the investigator has no clinical suspicion of active disease for >2 years before randomization are eligible)
- Prior treatment for AML; only hydroxyurea is permitted (see below)
- Acute promyelocytic leukemia [t(15;17)] or favorable cytogenetics, including t(8;21) or inv16 if known at the time of randomization
- Patients with a prior anthracycline exposure of greater than 368 mg/m2 daunorubicin (or equivalent)
- Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent obtaining informed consent
- Administration of any antineoplastic therapy within 4 weeks of the first CPX-351 dose; in the event of rapidly proliferative disease use of hydroxyurea is permitted until 24 hours before the start of study treatment
- Clinical evidence of active CNS leukemia
- Patients with history of and/or current evidence of myocardial impairment (e.g. cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, and congestive heart failure) resulting in heart failure by New York Heart Association Class III or IV staging
- Active and uncontrolled infection. Patients with an infection receiving treatment with antibiotics may be entered into the study if they are afebrile and hemodynamically stable for 72 hrs.
- Current evidence of invasive fungal infection (blood or tissue culture); HIV or active hepatitis C infection
- Hypersensitivity to cytarabine, daunorubicin or liposomal products
- History of Wilson's disease or other copper-related disorder
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: CPX-351 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 Arm B: Cytarabine + Daunorubicin 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 Arm B: Cytarabine + Daunorubicin Cytarabine 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
- Primary Outcome Measures
Name Time Method Number of Participants With Complete Remission 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.
- Secondary Outcome Measures
Name Time Method Remission Duration/Time to Remission 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 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 1 year Survival defined as the time from randomization to death.
Rate of Stem Cell Transplant Up to 1 year The rate of patients who underwent stem cell transplant.
Aplasia Rate Day 14 (1st Induction) Bone marrow aplasia was defined as \<20% cellularity and 5% blasts in the bone marrow aspiration evaluation.
Trial Locations
- Locations (28)
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
BC Cancer Research Center
🇨🇦Vancouver, British Columbia, Canada
McGill University Department of Oncology
🇨🇦Montreal, Quebec, Canada
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
St.Francis Hospital
🇺🇸Beech Grove, Indiana, United States
University of California Medical Center
🇺🇸San Francisco, California, United States
UC Davis Cancer Center
🇺🇸Sacramento, California, United States
Northern New Jersey Cancer Associates
🇺🇸Hackensack, New Jersey, United States
Texas Tech University Health Sciences Center
🇺🇸Lubbock, Texas, United States
Queen Elisabeth II Health Sciences Center
🇨🇦Halifax, Nova Scotia, Canada
Robert H.Lurie Comprehensive Cancer Center
🇺🇸Chicago, Illinois, United States
University of Colorado Cancer Center
🇺🇸Aurora, Colorado, United States
Shands Jacksonville Medical Center
🇺🇸Jacksonville, Florida, United States
H Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
Weil Cornell Medical Center
🇺🇸New York, New York, United States
Blood and Marrow Transplant Group of Georgia
🇺🇸Atlanta, Georgia, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Blumenthal Cancer Center/Mecklenburg Medical Group
🇺🇸Charlotte, North Carolina, United States
Jewish Hospital
🇺🇸Cincinnati, Ohio, United States
New York Medical College, Division of Oncology
🇺🇸Valhalla, New York, United States
Froedlert Hospital/Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
University of Pittsburg Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States
Joe Arrington Cancer Center
🇺🇸Lubbock, Texas, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Cancer Therapy and Research Center at the University of Texas
🇺🇸San Antonio, Texas, United States