CMA-676 in Treating Older Patients With Acute Myeloid Leukemia in First Relapse
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|ClinicalTrials.gov Identifier: NCT00003673|
Recruitment Status : Completed
First Posted : September 13, 2004
Last Update Posted : August 22, 2012
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of CMA-676 in treating older patients who have acute myeloid leukemia that has recurred for the first time following at least 3 months of complete remission.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: chemotherapy Drug: gemtuzumab ozogamicin||Phase 2|
OBJECTIVES: I. Assess the efficacy of CMA-676 in elderly patients with acute myeloid leukemia in first relapse in terms of the number of patients attaining a complete remission. II. Assess the safety of CMA-676 in this patient population.
OUTLINE: This is an open label, single arm, multicenter study. Patients receive 1 course of CMA-676 IV over 2 hours on day 1 followed by a 6 hour observation period. Patients may receive 1 additional course of therapy 15 to 28 days later. There is a 28 day follow-up period after the last dose of study medication. Patients are followed for an additional 6 months, then every 3 months for 18 months, and then every 6 months until relapse and/or death.
PROJECTED ACCRUAL: A total of 23-55 patients will be accrued for this study within 12 months. Enrollment will then be extended for up to an additional 55 patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Official Title:||A Study of the Safety of CMA-676 in Treatment of Elderly Patients With Acute Myeloid Leukemia (AML) in First Relapse|
|Study Start Date :||March 1998|
|Actual Primary Completion Date :||March 1999|
|Actual Study Completion Date :||March 1999|
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): NCT00003673
|United States, Arizona|
|Arizona Cancer Center|
|Tucson, Arizona, United States, 85724|
|United States, California|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-1781|
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University|
|Chicago, Illinois, United States, 60611|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637|
|United States, Massachusetts|
|New England Medical Center Hospital|
|Boston, Massachusetts, United States, 02111|
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201|
|United States, New York|
|Long Island Jewish Medical Center|
|New Hyde Park, New York, United States, 11040|
|New York Presbyterian Hospital - Cornell Campus|
|New York, New York, United States, 10021|
|State University of New York Health Sciences Center - Stony Brook|
|Stony Brook, New York, United States, 11790-9832|
|United States, Pennsylvania|
|University of Pennsylvania Cancer Center|
|Philadelphia, Pennsylvania, United States, 19104|
|Study Chair:||Mark Stanley Berger, MD||Wyeth is now a wholly owned subsidiary of Pfizer|