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Decitabine Versus Supportive Care in Adults With Advanced-Stage MDS

This study has been completed.

Sponsored by: SuperGen
Information provided by: SuperGen
ClinicalTrials.gov Identifier: NCT00043381
  Purpose

To compare the safety and efficacy profiles of decitabine to those of supportive care in adults with advanced-stage myelodysplastic syndrome (MDS)


Condition Intervention Phase
Myelodysplastic Syndrome
Drug: decitabine (5-aza-2'deoxycytidine)
Phase III

ChemIDplus related topics:   5-Aza-2'-deoxycytidine    Deoxycytidine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   A Randomized, Open-Label, Phase III Trial of Decitabine (5-Aza-2'Deoxycytidine) Versus Supportive Care in Adults With Advanced-Stage Myelodysplastic Syndrome

Further study details as provided by SuperGen:

Estimated Enrollment:   160
Study Start Date:   April 2001

Detailed Description:

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).

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion:

  • 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 </= 2 mg/dL, bilirubin </= 1.5 mg/dL, SGPT </= 2 times the upper limit of normal range)

Exclusion:

  • 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 initiation.
  • 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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00043381

Locations
United States, California
Loma Linda Univ. Cancer Center    
      Loma Linda, California, United States
Alta Bates Comprehensive Cancer Center    
      Berkeley, California, United States
Scripps Clinic    
      Escondido, California, United States
City of Hope National Medical Center    
      Duarte, California, United States
Univ. California San Francisco Medical School    
      San Francisco, California, United States
United States, Florida
University of Florida    
      Gainsville, Florida, United States
James A. Haley Veteran's Hospital    
      Tampa, Florida, United States
H. Lee Moffitt Cancer Center    
      Tampa, Florida, United States
United States, Illinois
University of Illinois at Chicago    
      Chicago, Illinois, United States
Rush Medical Center    
      Chicago, Illinois, United States
United States, Massachusetts
Dana Farber Cancer Institute    
      Boston, Massachusetts, United States
New England Medical Center Hospital    
      Boston, Massachusetts, United States
University of Massachusetts Medical School    
      Worcester, Massachusetts, United States
United States, Minnesota
VA Medical Center    
      Minneapolis, Minnesota, United States
United States, Missouri
Washington Univ. School of Medicine    
      St. Louis, Missouri, United States
United States, New York
Memorial Sloan Kettering Cancer Center    
      New York, New York, United States
Mount Sinai Medical Center    
      New York, New York, United States
Roswell Park Cancer Institute    
      Buffalo, New York, United States
United States, North Carolina
Duke University Medical Center    
      Durham, North Carolina, United States
UNC Lineberger Comprehensive Cancer Center    
      Chapel Hill, North Carolina, United States
United States, Tennessee
The Memphis Cancer Center    
      Memphis, Tennessee, United States
United States, Texas
SW Regional Cancer Center (dba Central Texas Oncology Associates)    
      Austin, Texas, United States
MD Anderson Cancer Center    
      Houston, Texas, United States
Texas Oncology    
      Dallas, Texas, United States

Sponsors and Collaborators
SuperGen
  More Information

Study ID Numbers:   D-0007
First Received:   August 8, 2002
Last Updated:   December 12, 2007
ClinicalTrials.gov Identifier:   NCT00043381
Health Authority:   United States: Food and Drug Administration

Keywords provided by SuperGen:
myelodysplastic syndrome  
MDS  
chronic myelomonocytic leukemia  
CMML
decitabine
5-aza-2'deoxycytidine

Study placed in the following topic categories:
Myelodysplastic syndromes
Leukemia
Preleukemia
Precancerous Conditions
Chronic myelomonocytic leukemia
Hematologic Diseases
Leukemia, Myelomonocytic, Chronic
Myelodysplasia
Myelodysplastic Syndromes
Azacitidine
Decitabine
Bone Marrow Diseases

Additional relevant MeSH terms:
Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Syndrome
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2008




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