Leukemia Clinical Trial
Official title:
A Study of the Efficacy and Safety of CMA-676 as Single Agent Treatment of Patients With Acute Myeloid Leukemia (AML) in First Relapse
Verified date | August 2012 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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 patients with
acute myeloid leukemia in first relapse.
Status | Completed |
Enrollment | 55 |
Est. completion date | February 2002 |
Est. primary completion date | February 2002 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: Histologically diagnosed CD33 positive acute myeloid leukemia
(AML) in first relapse At least 6 months of complete remission No CNS leukemia No AML
secondary to exposure to chemotherapy or toxins 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 |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
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 Chicago Cancer Research Center | Chicago | Illinois |
United States | Beckman Research Institute, City of Hope | Duarte | California |
United States | University of Texas - MD Anderson Cancer Center | Houston | Texas |
United States | Sylvester Cancer Center, University of Miami | Miami | Florida |
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 Nebraska Medical Center | Omaha | Nebraska |
United States | University of Pennsylvania Cancer Center | Philadelphia | Pennsylvania |
United States | Fred Hutchinson Cancer Research Center | Seattle | Washington |
United States | Arizona Cancer Center | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States,
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. — View Citation
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