Trial of CPX-351 in Adult Patients With First Relapse Acute Myeloid Leukemia (AML)
NCT ID: NCT00822094
Last Updated: 2017-11-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
126 participants
INTERVENTIONAL
2009-02-28
2012-01-31
Brief Summary
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The study compares the investigational product CPX-351 vs the standard intensive salvage treatment for first relapse AML patients.
Detailed Description
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Patients are stratified to balance the likelihood of obtaining a CR and the duration of CR between the two arms.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CPX-351 (Arm A)
First induction: 100 units/m2 on Days 1, 3, and 5 by 90-minute IV infusion Second induction: 100 units/m2 on Days 1 and 3 by 90-minute IV infusion Consolidation(s): 100 units/m2 on Days 1 and 3 by 90-minute IV infusion
CPX-351
Salvage Therapy (Arm B)
First induction: Investigator's choice salvage therapy administered according to local practice Second induction: Investigator's choice salvage therapy administered according to local practice Consolidation(s): Investigator's choice consolidation therapy administered according to local practice
Intensive Salvage Therapy
Interventions
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CPX-351
Intensive Salvage Therapy
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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The Leukemia and Lymphoma Society
OTHER
Jazz Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Jonathan Kolitz, MD
Role: PRINCIPAL_INVESTIGATOR
North Shore University Hospital
Locations
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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
M.D. Anderson Cancer Center
Houston, Texas, United States
Joe Arrington Cancer Center
Lubbock, Texas, United States
Texas Tech University Health Sciences Center
Lubbock, Texas, United States
Cancer Therapy and Research Center at The University of TX Health Science Center
San Antonio, Texas, United States
Intermountain LDS Hospital
Salt Lake City, Utah, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Vancouver General Hospital/ British Columbia Cancer Agency
Vancouver, British Columbia, Canada
Cancer Care Manitoba
Winnipeg, Manitoba, Canada
Service des Maladies du Sang CHU de Lille, Hopital Claude Huriez
Lille, , France
Service des Maladies du Sang Hopital Haut-Leveque
Pessac, , France
Service d'Hématologie CHU Toulouse-Hôpital Purpan
Toulouse, , France
Service d'Hématologie et Médecine Interne CHU de Nancy-Hôpital de Brabois
Vandœuvre-lès-Nancy, , France
Klinika Hematologii i Transplantologii
Gdansk, , Poland
Wojewódzki Szpital Specjalistyczny im. M. Kopernika
Lodz, , Poland
Oddział Hematologii
Opole, , Poland
Instytut Hematologii i Transfuzjologii
Warsaw, , Poland
Akademia Medyczna we Wroclawlu
Wroclaw, , Poland
Countries
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Other Identifiers
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CLTR0308-205
Identifier Type: -
Identifier Source: org_study_id