CMA-676 in Treating Patients With Acute Myeloid Leukemia in First Relapse
NCT ID: NCT00003131
Last Updated: 2012-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
55 participants
INTERVENTIONAL
1997-02-28
2002-02-28
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of CMA-676 in treating patients with acute myeloid leukemia in first relapse.
Detailed Description
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OUTLINE: This is an open label, single arm, multicenter study. Patients receive CMA-676 IV over 2 hours on day 1. Patients may receive 1 additional dose of therapy 15 to 28 days later. Patients who achieve complete or morphologic remission are followed for an additional 6 months and every 3-6 months thereafter until relapse and/or death.
PROJECTED ACCRUAL: 55 evaluable patients will be accrued. Enrollment will then be extended for up to an additional 55 patients.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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chemotherapy
gemtuzumab ozogamicin
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC less than 30,000/mm3 at time of CMA-676 administration Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No severe cardiac disease Pulmonary: No severe pulmonary disease Other: Not pregnant or nursing Fertile patients must use an effective method of contraception Not known to be HIV positive No prior myelodysplastic syndrome No other active malignancy No uncontrolled infections Able to obtain bone marrow aspirate
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow transplantation No prior anti-CD33 antibody therapy Chemotherapy: No prior chemotherapy for AML in first relapse except hydroxyurea At least 24 hours since prior hydroxyurea Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: At least 4 weeks since prior investigational agents
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Stanley Berger, MD
Role: STUDY_CHAIR
Wyeth is now a wholly owned subsidiary of Pfizer
Locations
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Arizona Cancer Center
Tucson, Arizona, United States
Beckman Research Institute, City of Hope
Duarte, California, United States
Sylvester Cancer Center, University of Miami
Miami, Florida, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States
New England Medical Center Hospital
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
New York Presbyterian Hospital - Cornell Campus
New York, New York, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Countries
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References
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Lang K, Menzin J, Earle CC, Mallick R. Outcomes in patients treated with gemtuzumab ozogamicin for relapsed acute myelogenous leukemia. Am J Health Syst Pharm. 2002 May 15;59(10):941-8. doi: 10.1093/ajhp/59.10.941.
Hibma J, Knight B. Population Pharmacokinetic Modeling of Gemtuzumab Ozogamicin in Adult Patients with Acute Myeloid Leukemia. Clin Pharmacokinet. 2019 Mar;58(3):335-347. doi: 10.1007/s40262-018-0699-5.
Other Identifiers
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CDR0000065896
Identifier Type: -
Identifier Source: secondary_id
UCCRC-8600
Identifier Type: -
Identifier Source: secondary_id
NCI-V97-1355
Identifier Type: -
Identifier Source: secondary_id
W-AR-0903B1-201-US
Identifier Type: -
Identifier Source: org_study_id