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CMA-676 in Treating Older Patients With Acute Myeloid Leukemia in First Relapse

Last updated on May 11, 2018

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Study Location
Arizona Cancer Center
Tucson, Arizona, 85724 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Leukemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
60+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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NCT00003673
Pfizer
Completed
CMA-676 in Treating Older Patients With Acute Myeloid Leukemia in First Relapse

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CMA-676 in Treating Older Patients With Acute Myeloid Leukemia in First Relapse
A Study of the Safety of CMA-676 in Treatment of Elderly Patients With Acute Myeloid Leukemia (AML) in First Relapse

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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
Leukemia
  • Drug: chemotherapy
  • Drug: gemtuzumab ozogamicin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
March 1999
March 1999   (Final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS: CD33 positive acute myeloid leukemia in first relapse At least 3 months of complete remission No history of a secondary leukemia evolving from a known prior myelodysplastic syndrome or resulting from exposure to chemotherapy or toxins No active CNS leukemia

PATIENT CHARACTERISTICS: Age: 60 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 2.0 mg/dL Renal: Creatinine no greater than 3.0 mg/dL Cardiovascular: No uncontrolled cardiac disease Pulmonary: No uncontrolled pulmonary disease Other: No other active malignancy No uncontrolled, life-threatening infections Able to obtain bone marrow aspirate HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow and peripheral blood stem cells transplantation No prior anti-CD33 antibody therapy Chemotherapy: Prior cytotoxic chemotherapy for AML allowed No prior chemotherapy for AML in first relapse except hydroxyurea At least 24 hours since prior hydroxyurea Recovered from prior antineoplastic therapy (except alopecia) No concurrent cytotoxic chemotherapy Endocrine therapy: No concurrent immunosuppressive therapy Radiotherapy: Not specified Surgery: Not specified Other: At least 4 weeks since prior investigational agents No other concurrent antileukemic therapy

Sexes Eligible for Study: All
60 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00003673
W-AR-0903B1-203-US
CDR0000066771
NCI-V98-1497
Not Provided
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Chair: Mark Stanley Berger, MD Wyeth is now a wholly owned subsidiary of Pfizer
Pfizer
August 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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