Trial of CPX-351 in Newly Diagnosed Elderly AML Patients

NCT ID: NCT00788892

Last Updated: 2018-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2011-12-31

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.

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A: 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

Group Type: EXPERIMENTAL

CPX-351

Intervention Type: DRUG

Arm B: Cytarabine + 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

Group Type: ACTIVE_COMPARATOR

Cytarabine

Intervention Type: DRUG

Daunorubicin

Intervention Type: DRUG

Interventions

CPX-351

Intervention Type: DRUG

Cytarabine

Intervention Type: DRUG

Daunorubicin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

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)
• 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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jazz Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey E Lancet, MD

Role: PRINCIPAL_INVESTIGATOR

H. Lee Moffitt Cancer Center

Locations

Arizona Cancer Center

Tucson, Arizona, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

UC Davis Cancer Center

Sacramento, California, United States

University of California Medical Center

San Francisco, California, 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

Blood and Marrow Transplant Group of Georgia

Atlanta, Georgia, United States

Robert H.Lurie Comprehensive Cancer Center

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

St.Francis Hospital

Beech Grove, Indiana, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Northern New Jersey Cancer Associates

Hackensack, New Jersey, United States

North Shore University Hospital

Manhasset, New York, United States

Weil Cornell Medical Center

New York, New York, United States

New York Medical College, Division of Oncology

Valhalla, New York, United States

Blumenthal Cancer Center/Mecklenburg Medical Group

Charlotte, North Carolina, United States

Jewish Hospital

Cincinnati, Ohio, United States

Oregon Health and Science University

Portland, Oregon, United States

University of Pittsburg Cancer Center

Pittsburgh, Pennsylvania, United States

MD 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 Texas

San Antonio, Texas, United States

Froedlert Hospital/Medical College of Wisconsin

Milwaukee, Wisconsin, United States

BC Cancer Research Center

Vancouver, British Columbia, Canada

Queen Elisabeth II Health Sciences Center

Halifax, Nova Scotia, Canada

McGill University Department of Oncology

Montreal, Quebec, Canada

Countries

United States; Canada

References

Lancet JE, Cortes JE, Hogge DE, Tallman MS, Kovacsovics TJ, Damon LE, Komrokji R, Solomon SR, Kolitz JE, Cooper M, Yeager AM, Louie AC, Feldman EJ. Phase 2 trial of CPX-351, a fixed 5:1 molar ratio of cytarabine/daunorubicin, vs cytarabine/daunorubicin in older adults with untreated AML. Blood. 2014 May 22;123(21):3239-46. doi: 10.1182/blood-2013-12-540971. Epub 2014 Mar 31.

Reference Type: DERIVED

PMID: 24687088 (View on PubMed)

Other Identifiers

CLTR0308-204

Identifier Type: -

Identifier Source: org_study_id