Completed

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

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What is being tested

Data Collection

Who is being recruted

Anemia+14

+ Anemia, Refractory

+ Anemia, Refractory, with Excess of Blasts

Over 15 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: April 1998
See protocol details

Summary

Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 1998

Actual date on which the first participant was enrolled.

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.

Official TitlePhase II Study With Decitabine (5-aza-2'-Deoxycytidine, DAC) in Myelodysplastic Syndromes
NCT00003361
Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

75 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 15 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AnemiaAnemia, RefractoryAnemia, Refractory, with Excess of BlastsBone Marrow DiseasesChronic DiseaseHematologic DiseasesHemic and Lymphatic DiseasesLeukemiaLeukemia, MyeloidMyelodysplastic SyndromesNeoplasmsNeoplasms by Histologic TypePathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, Myelomonocytic, ChronicDisease AttributesMyelodysplastic-Myeloproliferative Diseases

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

Johns Hopkins Oncology Center

Baltimore, United StatesOpen Johns Hopkins Oncology Center in Google Maps
Suspended

Memorial Sloan-Kettering Cancer Center

New York, United States
Suspended

University of Texas - MD Anderson Cancer Center

Houston, United States
Completed3 Study Centers