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Phase II Study With Decitabine (5-aza-2'-Deoxycytidine, DAC) in Myelodysplastic Syndromes

Phase 2
15 Years
Not Enrolling
Leukemia, Myelodysplastic Syndromes

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Trial Information

Phase II Study With Decitabine (5-aza-2'-Deoxycytidine, DAC) in Myelodysplastic Syndromes

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.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven myelodysplastic syndrome Refractory anemia
(RA) RA with ringed sideroblasts (RARS) RA with excess blasts (RAEB) RAEB in
transformation Chronic myelomonocytic leukemia (CMML) RA and RARS: Platelet count less
than 50,000/mm3 CMML: If WBC greater than 10,000/mm3, then must have at least 8% monocytes
in the blood or marrow

PATIENT CHARACTERISTICS: Age: 15 and over Performance status: Zubrod 0-2 Life expectancy:
Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater
than 2.0 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No New York
Heart Association class III or IV heart disease Other: No active or uncontrolled infection
Not pregnant or nursing Fertile patients must use effective contraception No other active
cancer except skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than one
prior chemotherapy regimen for myelodysplastic syndromes At least 3 weeks since
chemotherapy and recovered No prior high-dose cytarabine (at least 0.5 g/m2 for at least 4
doses) Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Stephen D. Nimer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

April 1998

Completion Date:

December 2009

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndromes
  • refractory anemia
  • refractory anemia with ringed sideroblasts
  • refractory anemia with excess blasts
  • refractory anemia with excess blasts in transformation
  • chronic myelomonocytic leukemia
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • childhood myelodysplastic syndromes
  • Leukemia
  • Myelodysplastic Syndromes
  • Preleukemia



Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
Johns Hopkins Oncology Center Baltimore, Maryland  21287