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Decitabine in Treating Patients With Myelodysplastic Syndrome

Phase 2
Completed
Conditions
Leukemia
Myelodysplastic Syndromes
Registration Number
NCT00003361
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of decitabine in treating patients with myelodysplastic syndrome.

Detailed Description

OBJECTIVES: I. Determine the response of patients with myelodysplastic syndromes (including chronic myelomonocytic leukemia) to decitabine.

OUTLINE: This is an open label, multicenter study. Patients are stratified by disease (low risk myelodysplastic syndrome (MDS) vs. high risk MDS vs. chronic myelomonocytic leukemia). Patients receive decitabine as a 4 hour infusion every 8 hours on days 1-3. Treatment continues every 6-8 weeks for 4-6 courses. Patients are followed at 6 and 12 months.

PROJECTED ACCRUAL: Approximately 75 patients will be accrued for this study over 1 year.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
75
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (3)

Johns Hopkins Oncology Center

πŸ‡ΊπŸ‡Έ

Baltimore, Maryland, United States

Memorial Sloan-Kettering Cancer Center

πŸ‡ΊπŸ‡Έ

New York, New York, United States

University of Texas - MD Anderson Cancer Center

πŸ‡ΊπŸ‡Έ

Houston, Texas, United States

Johns Hopkins Oncology Center
πŸ‡ΊπŸ‡ΈBaltimore, Maryland, United States

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