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Trial of CPX-351 in Newly Diagnosed Elderly AML Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00788892
Recruitment Status : Completed
First Posted : November 11, 2008
Results First Posted : January 12, 2018
Last Update Posted : January 12, 2018
Information provided by (Responsible Party):
Jazz Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: CPX-351 Drug: Cytarabine Drug: Daunorubicin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IIB, Multicenter, Randomized, Open Label Trial of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection Versus Cytarabine and Daunorubicin in Patients With Untreated AML 60-75 Years of Age.
Study Start Date : October 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : December 2011

Arm Intervention/treatment
Experimental: 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
Drug: CPX-351
Active Comparator: 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
Drug: Cytarabine
Drug: Daunorubicin

Primary Outcome Measures :
  1. Number of Participants With Complete Remission [ Time Frame: Within 6 weeks of the last induction treatment ]
    Response was defined according to International Working Group Criteria (Cheson, et al. 2003) which requires peripheral blood neutrophils of >1000/µL and peripheral blood platelets of >100,000/µL in the absence of bone marrow blasts.

Secondary Outcome Measures :
  1. Remission Duration/Time to Remission [ Time Frame: Following achievement of CR over the study period ]

    Remission Duration was assessed from the time measurement criteria for CR were met until the first date that disease relapse was objectively documented or the subject died.

    Time to remission was measured from the date of randomization to the time measurement criteria for CR were first met.

  2. Event Free Survival [ Time Frame: Up to 1 year from randomization ]
    Event-free survival begins from randomization to the date persistent disease is documented or date of relapse after CR, or death, whichever comes first.

  3. Overall Survival Rate at 1 Year [ Time Frame: 1 year ]
    Survival defined as the time from randomization to death.

  4. Rate of Stem Cell Transplant [ Time Frame: Up to 1 year ]
    The rate of patients who underwent stem cell transplant.

  5. Aplasia Rate [ Time Frame: Day 14 (1st Induction) ]
    Bone marrow aplasia was defined as <20% cellularity and 5% blasts in the bone marrow aspiration evaluation.

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00788892

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Sponsors and Collaborators
Jazz Pharmaceuticals
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Principal Investigator: Jeffrey E Lancet, MD H. Lee Moffitt Cancer Center

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jazz Pharmaceuticals Identifier: NCT00788892     History of Changes
Other Study ID Numbers: CLTR0308-204
First Posted: November 11, 2008    Key Record Dates
Results First Posted: January 12, 2018
Last Update Posted: January 12, 2018
Last Verified: October 2017
Keywords provided by Jazz Pharmaceuticals:
Additional relevant MeSH terms:
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Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors