Acute myeloid leukemia recurrent (Acute Myeloid Leukemia in First Relapse Following an Initial CR >1 Month Duration). MedDRA version: 12.0 Level: LLT Classification code 10060558 Term: Acute myeloid leukemia recurrent
Conditions
Interventions
Product Name: CPX-351
Product Code: CPX-351
Pharmaceutical Form: Liposomal dispersion for infusion
INN or Proposed INN: CYTARABINE
CAS Number: 147-94-4
Concentration unit: mg/ml milligram(s)/millilitr
Sponsors
Celator Pharmaceuticals, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Ability to understand and voluntarily sign an informed consent form • Age 18- 60 years at the time of relapse • Pathological confirmation of relapsed AML after initial CR of >1 month duration • 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: o Serum creatinine =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • 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) • Acute promyelocytic leukemia [t(15;17)] • Total lifetime anthracycline exposure exceeding the equivalent of 368 mg/m2 of daunorubicin (or equivalent) prior to start of study therapy • Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent obtaining informed consent • Administration of any antineoplastic therapy intended to treat first relapse. 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 New York Heart Association Class III or IV staging • Active and uncontrolled infection. Patients with a bacterial 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) or active hepatitis C infection (evidenced by rising LFT abnormalities). •Patients with known HIV infection are excluded (testing for HIV infection is not required). • Hypersensitivity to cytarabine, daunorubicin or liposomal products • History of Wilson’s disease or other copper-related disorder • Patients with a history of severe toxicity related to receiving conventional dose cytarabine in first line treatment (approximately 100mg/m2/d for <7 days) are excluded. Patients who experienced unacceptable toxicities while receiving high dose cytarabine (approximately 3000mg/m2 for 6 doses) will not be treated again with the same regimen, but could be randomized to treatment with conventional dose cytarabine regimens where the risk of major toxicity is less. • Woman who are pregnant or breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate the efficacy of CPX-351 at 100units/m2 when compared to intensive salvage therapy in patients with AML in first relapse. Efficacy will be measured by by proportion of patients surviving at 1 year.;Secondary Objective: • To estimate event-free survival (EFS), CR rate and CR duration, relative to control • To estimate the rate of aplasia after a single induction and after 2 inductions • To estimate the rate of transfers to stem cell transplants • To confirm the safety of CPX-351 as induction therapy and to gather additional safety information when CPX-351 is used as consolidation therapy;Primary end point(s): The primary endpoint is the proportion of patients’ surviving at 1 year. Patients will be stratified according to the European Prognostic Index (favorable v. intermediate v. unfavorable). 120 patients will be enrolled in the study with 80 patients randomized to the CPX-351 arm and 40 patients randomized to the control arm. Assuming the number of deaths at 1 year is binomially distributed, this design with 120 patients randomized in a 2:1 ratio has 83% power (with a one sided alpha= 0.1) to detect an absolute increase of 21% in survival rate at 1 year. | — |
Countries
France
Outcome results
None listed