Trial of CPX-351 in Adult Patients With First Relapse Acute Myeloid Leukemia (AML)

Completed · Phase 2

Conditions studied: Acute Myeloid Leukemia

In brief

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.

Key facts

Study ID: NCT00822094
Run by: Jazz Pharmaceuticals
People needed: 126
Starts: 2009-02-01
Expected to finish: 2012-01-01
Last updated by the study team: 2017-11-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Ability to understand and voluntarily sign an informed consent form
Age ≥18 and ≤65 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:
Serum creatinine < 2.0 mg/dL
Serum total bilirubin < 2.0 mg/dL
Serum alanine aminotransferase or aspartate aminotransferase <3xULN 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.

You may not qualify if…

Patients with active second malignancies are excluded. Patients with second malignancies in remission may be eligible if there is no clinical evidence of active disease, documented by imaging, with tumor marker studies, etc., at screening. Patients maintained on long-term non-chemotherapy treatment, e.g., hormonal therapy, are eligible. In all cases, the second malignancy and its non-chemotherapy treatment must not interfere with the investigators ability to assess the safety or efficacy of the study treatment
Patients with 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 within 4 weeks of 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); active hepatitis C infection or known HIV infection
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

Where it is running

Arizona Cancer Center — Tucson, Arizona, United States
UCLA — Los Angeles, California, United States
Cedars Sinai Medical Center — Los Angeles, California, United States
UC Davis Cancer Center — Sacramento, California, United States
University of Colorado Cancer Center — Aurora, Colorado, United States
Northwestern University Robert H. Lurie Comprehensive Cancer Center — Chicago, Illinois, United States
Rush University Medical Center — Chicago, Illinois, United States
University of Chicago Medical Center Section of Hematology/Oncology — Chicago, Illinois, United States
St. Francis Cancer Center — Beech Grove, Indiana, United States
University of Louisville Brown Cancer Center — Louisville, Kentucky, United States
Maine General Medical Center Harold Alfond Center for Cancer Care — Waterville, Maine, United States
Johns Hopkins University — Baltimore, Maryland, United States
St. Louis University Medical Center — St Louis, Missouri, United States
The Cancer Center, Hackensack University Medical Center — Hackensack, New Jersey, United States
North Shore LIJ Center for Advanced Medicine Monter Cancer Center — Lake Success, New York, United States
Weil Cornell Medical Center — New York, New York, United States
New York Medical College — New York, New York, United States
Montefiore Medical Center — The Bronx, New York, United States
Blumenthal Cancer Center/Mecklenburg Medical Group — Charlotte, North Carolina, United States
Duke Comprehensive Cancer Center — Durham, North Carolina, United States
Jewish Hospital of Cincinatti — Cincinnati, Ohio, United States
Oregon Health and Science University — Portland, Oregon, United States
Oncology and Hematology at Lehigh Valley — Bethlehem, Pennsylvania, United States
Western Pennsylvania Hospital — Pittsburgh, Pennsylvania, United States
UTMB Comprehensive Cancer Center — Galveston, Texas, United States

Full record on ClinicalTrials.gov

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