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A Randomized, Open-label, Phase III Trial of Decitabine (5-aza-2'Deoxycytidine) Versus Supportive Care in Adults With Advanced-stage Myelodysplastic Syndrome

Phase 3
18 Years
Not Enrolling
Myelodysplastic Syndrome

Thank you

Trial Information

A Randomized, Open-label, Phase III Trial of Decitabine (5-aza-2'Deoxycytidine) Versus Supportive Care in Adults With Advanced-stage Myelodysplastic Syndrome

This experimental (investigational) study is intended to answer the question of whether
decitabine is any better than supportive care alone in delaying progression (worsening) of
the disease, prolonging survival or improving the overall quality of life for MDS patients
who are not candidates for bone marrow transplant (BMT).

Inclusion Criteria


- MDS (de novo or secondary) fitting any of the recognized French-American-British,
FAB, classifications or chronic myelomonocytic leukemia (CMML) with WBC < 12,000/mm3,
AND International Prognostic Scoring System (IPSS) >/= 0.5 as determined by CBC, bone
marrow assessment and bone marrow cytogenetics within 30 days of randomization

- 18 years or older

- Female patients of child-bearing potential must have a negative serum hCG within 24
hours prior to randomization, must practice a medically approved method of birth
control for the past 30 days, and agree to continue this practice for the trial
duration and must not be breast-feeding

- ECOG or WHO performance status of 0-2

- Written informed consent

- Normal renal and hepatic function (creatinine SGPT

- Acute Myeloid Leukemia (AML) (>/=30% bone marrow blasts) or other progressive
malignant disease

- Patients must have recovered from the toxic effects of prior therapy and must be off
all chemotherapy for a minimum of 4 weeks prior to study entry to the protocol (a
minimum of six weeks for prior nitrosoureas and bone marrow transplantation)

- Ongoing treatment with androgenic hormones, danazol, colony-stimulating factors, or
other agents used to treat MDS within 7 days of study initiation.

- Administration of any investigational agent within the 30 days preceding study

- Uncontrolled cardiac disease or congestive heart failure

- Uncontrolled restrictive or obstructive pulmonary disease

- Active viral or bacterial infection

- Superimposed autoimmune hemolytic anemia or thrombocytopenia

- Known positive serology for HIV

- Mental illness or other condition preventing full cooperation with the treatment and
monitoring requirements of the study.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:




Start Date:

April 2001

Completion Date:

April 2003

Related Keywords:

  • Myelodysplastic Syndrome
  • myelodysplastic syndrome
  • MDS
  • chronic myelomonocytic leukemia
  • CMML
  • decitabine
  • 5-aza-2'deoxycytidine
  • Myelodysplastic Syndromes
  • Preleukemia



Memorial Sloan Kettering Cancer Center New York, New York  10021
MD Anderson Cancer Center Houston, Texas  77030-4096
Roswell Park Cancer Institute Buffalo, New York  14263
New England Medical Center Hospital Boston, Massachusetts  02111
Scripps Clinic La Jolla, California  92037
University of Illinois at Chicago Chicago, Illinois  60612
Mount Sinai Medical Center New York, New York  10029
City of Hope National Medical Center Los Angeles, California  91010
Alta Bates Comprehensive Cancer Center Berkeley, California  94704
Duke University Medical Center Durham, North Carolina  27710
University of Florida Gainesville, Florida  32610-0277
Rush Medical Center Chicago, Illinois  60612
H. Lee Moffitt Cancer Center Tampa, Florida  33612
Dana Farber Cancer Institute Boston, Massachusetts  02115
University of Massachusetts Medical School Worcester, Massachusetts  01605
Loma Linda Univ. Cancer Center Loma Linda, California  
Univ. California San Francisco Medical School San Francisco, California  
James A. Haley Veteran's Hospital Tampa, Florida  
VA Medical Center Minneapolis, Minnesota  
Washington Univ. School of Medicine St. Louis, Missouri  
UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina  
The Memphis Cancer Center Memphis, Tennessee  
SW Regional Cancer Center (dba Central Texas Oncology Associates) Austin, Texas  
Texas Oncology Dallas, Texas