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Trial of CPX-351 in Newly Diagnosed Elderly AML Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celator Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00788892
First received: November 10, 2008
Last updated: May 16, 2012
Last verified: May 2012

November 10, 2008
May 16, 2012
October 2008
June 2010   (final data collection date for primary outcome measure)
Complete Remission Rate [ Time Frame: Following 1st induction, following 2nd induction if applicable ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00788892 on ClinicalTrials.gov Archive Site
  • Response Duration [ Time Frame: Following achievement of CR and up to 2 years from randomization ] [ Designated as safety issue: No ]
  • Event Free Survival [ Time Frame: Up to 2 years from randomization ] [ Designated as safety issue: No ]
  • Survival at 2 years [ Time Frame: Up to 2 years from randomization ] [ Designated as safety issue: No ]
  • rate of stem cell transplant [ Time Frame: Up to 2 years from randomization ] [ Designated as safety issue: No ]
  • Early induction mortality at day 30 and at day 60 from start of 1st induction [ Time Frame: day 30 and day 60 from 1st induction ] [ Designated as safety issue: Yes ]
  • Late mortality [ Time Frame: following Day 90 from 1st induction ] [ Designated as safety issue: Yes ]
  • Response Duration [ Time Frame: Following achievement of CR and up to 1 year from randomization ] [ Designated as safety issue: No ]
  • Event Free Survival [ Time Frame: Up to 1 year from randomization ] [ Designated as safety issue: No ]
  • Survival at 1 year [ Time Frame: Up to 1 year from randomization ] [ Designated as safety issue: No ]
  • rate of stem cell transplant [ Time Frame: Up to 1 year from randomization ] [ Designated as safety issue: No ]
  • Early induction mortality at day 30 and at day 60 from start of 1st induction [ Time Frame: day 30 and day 60 from 1st induction ] [ Designated as safety issue: Yes ]
  • Late mortality [ Time Frame: following Day 90 from 1st induction ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Trial of CPX-351 in Newly Diagnosed Elderly AML Patients
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.

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Myeloid Leukemia
  • Drug: CPX-351
    CPX-351 at 100u/m2 will be administered on study days 1, 3 and 5 as a 90 minute infusion
  • Drug: Cytarabine + Daunorubicin - 7 and 3
    Cytarabine at a dose of 100mg/m2/day for 7 days plus daunorubicin at dose of 60mg/m2 for 3 days
  • Experimental: Arm A- CPX-351
    Intervention: Drug: CPX-351
  • Active Comparator: Arm B- 7 and 3 regimen
    Intervention: Drug: Cytarabine + Daunorubicin - 7 and 3
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
126
December 2011
June 2010   (final data collection date for primary outcome measure)

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
Both
60 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00788892
CLTR0308-204
Yes
Celator Pharmaceuticals
Celator Pharmaceuticals
Not Provided
Principal Investigator: Jeffrey E Lancet, MD H. Lee Moffitt Cancer Center
Celator Pharmaceuticals
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP