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Trial of CPX-351 in Newly Diagnosed Elderly AML Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00788892
First Posted: November 11, 2008
Last Update Posted: July 28, 2016
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.
Information provided by (Responsible Party):
Jazz Pharmaceuticals
  Purpose

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 Intervention Phase
Acute Myeloid Leukemia Drug: CPX-351 Drug: Cytarabine Drug: Daunorubicin Phase 2

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Jazz Pharmaceuticals:

Primary Outcome Measures:
  • Complete Remission Rate [ Time Frame: Following 1st induction, following 2nd induction if applicable ]

Secondary Outcome Measures:
  • Response Duration [ Time Frame: Following achievement of CR and up to 2 years from randomization ]
  • Event Free Survival [ Time Frame: Up to 2 years from randomization ]
  • Survival at 2 years [ Time Frame: Up to 2 years from randomization ]
  • rate of stem cell transplant [ Time Frame: Up to 2 years from randomization ]
  • 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 ]
  • Late mortality [ Time Frame: following Day 90 from 1st induction ]

Enrollment: 126
Study Start Date: October 2008
Study Completion Date: December 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: CPX-351
Arm A
Drug: CPX-351
CPX-351 at 100u/m2 will be administered on study days 1, 3 and 5 as a 90 minute infusion
Active Comparator: Arm B: Cytarabine + Daunorubicin
"7 + 3" regimen
Drug: Cytarabine
Cytarabine at a dose of 100mg/m2/day for 7 days
Drug: Daunorubicin
Daunorubicin at dose of 60mg/m2 for 3 days

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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


  Show 28 Study Locations
Sponsors and Collaborators
Jazz Pharmaceuticals
Investigators
Principal Investigator: Jeffrey E Lancet, MD H. Lee Moffitt Cancer Center
  More Information

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 Submitted: November 10, 2008
First Posted: November 11, 2008
Last Update Posted: July 28, 2016
Last Verified: July 2016

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


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