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Trial of CPX-351 in Newly Diagnosed Elderly AML Patients

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ClinicalTrials.gov Identifier: NCT00788892
Recruitment Status : Completed
First Posted : November 11, 2008
Results First Posted : January 12, 2018
Last Update Posted : January 12, 2018
Sponsor:
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.


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.



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

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 ClinicalTrials.gov identifier (NCT number): NCT00788892


  Hide Study Locations
Locations
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724-5024
United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
UC Davis Cancer Center
Sacramento, California, United States, 95817
University of California Medical Center
San Francisco, California, United States, 94143
United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
United States, Florida
Shands Jacksonville Medical Center
Jacksonville, Florida, United States, 32209
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United States, Georgia
Blood and Marrow Transplant Group of Georgia
Atlanta, Georgia, United States, 30342
United States, Illinois
Robert H.Lurie Comprehensive Cancer Center
Chicago, Illinois, United States, 60611
Rush University Medical Center
Chicago, Illinois, United States, 60612-3861
United States, Indiana
St.Francis Hospital
Beech Grove, Indiana, United States, 46107
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Northern New Jersey Cancer Associates
Hackensack, New Jersey, United States, 07601
United States, New York
North Shore University Hospital
Manhasset, New York, United States, 11020
Weil Cornell Medical Center
New York, New York, United States, 10021
New York Medical College, Division of Oncology
Valhalla, New York, United States, 10595
United States, North Carolina
Blumenthal Cancer Center/Mecklenburg Medical Group
Charlotte, North Carolina, United States, 28204
United States, Ohio
Jewish Hospital
Cincinnati, Ohio, United States, 45236
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pittsburg Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Joe Arrington Cancer Center
Lubbock, Texas, United States, 79410
Texas Tech University Health Sciences Center
Lubbock, Texas, United States, 79415
Cancer Therapy and Research Center at the University of Texas
San Antonio, Texas, United States, 78229
United States, Wisconsin
Froedlert Hospital/Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Canada, British Columbia
BC Cancer Research Center
Vancouver, British Columbia, Canada, V5Z 1L3
Canada, Nova Scotia
Queen Elisabeth II Health Sciences Center
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Quebec
McGill University Department of Oncology
Montreal, Quebec, Canada, H2W 1S6
Sponsors and Collaborators
Jazz Pharmaceuticals
Investigators
Principal Investigator: Jeffrey E Lancet, MD H. Lee Moffitt Cancer Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov 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:
Acute
Myeloid
Leukemia
elderly
Newly
Diagnosed

Additional relevant MeSH terms:
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Daunorubicin
Antimetabolites, Antineoplastic
Antimetabolites
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