EUCTR2009-010951-28-FRActive, not recruitingNot Applicable
Phase IIB, multicenter, randomized, open-label trial of CPX-351 (Cytarabine:Daunorubicin) liposome injection versus intensive salvage therapy in adult patients = 60 years old with AML in first relapse following an initial CR > 1 month duration
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Celator Pharmaceuticals, Inc
- Enrollment
- 120
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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 < 2.0 mg/dL
- •o Serum total bilirubin < 2.0 mg/dL
- •o Serum alanine aminotransferase or aspartate aminotransferase < 3X ULN. Note: If elevated liver enzymes are related to disease; contact medical monitor to discuss.
- •Cardiac ejection fraction 50% by echocardiography or MUGA scan
- •All men and women must agree to practice effective contraception during the study period and for 3 months afterward if not otherwise documented to be infertile.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •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)
- •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
Investigators
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