Trial of CPX-351 in Newly Diagnosed Elderly AML Patients - Full Text View

Sponsor:	Celator Pharmaceuticals
Information provided by:	Celator Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00788892

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 + Daunorubicin - 7 and 3	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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:

MedlinePlus related topics: Acute Myeloid Leukemia Cancer Leukemia

Drug Information available for: Cytarabine hydrochloride Daunorubicin Daunorubicin hydrochloride Cytarabine

U.S. FDA Resources

Further study details as provided by Celator Pharmaceuticals:

Primary Outcome Measures:

Complete Remission Rate [ Time Frame: Following 1st induction, following 2nd induction if applicable ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	120
Study Start Date:	October 2008
Estimated 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	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- 7 and 3 regimen	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

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

Ages Eligible for Study:	60 Years to 75 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00788892

Show 28 Study Locations

Sponsors and Collaborators

Celator Pharmaceuticals

Investigators

Principal Investigator:

Jeffrey E Lancet, MD

H. Lee Moffitt Cancer Center

More Information

No publications provided

Responsible Party:	Arhur C. Louie MD, CMO, Celator Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:	NCT00788892 History of Changes
Other Study ID Numbers:	CLTR0308-204
Study First Received:	November 10, 2008
Last Updated:	June 16, 2011
Health Authority:	United States: Food and Drug Administration; Canada: Therapeutic Products Directorate

Keywords provided by Celator Pharmaceuticals:

Acute
Myeloid
Leukemia

elderly
Newly
Diagnosed

Additional relevant MeSH terms:

Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Daunorubicin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on February 09, 2012