Decitabine Versus Supportive Care in Adults With Advanced-stage MDS

January 22, 2013 updated by: Astex Pharmaceuticals, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment

160

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astex Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Primary Completion (Actual)

November 1, 2002

Study Completion (Actual)

April 1, 2003

Study Registration Dates

First Submitted

August 8, 2002

First Submitted That Met QC Criteria

August 9, 2002

First Posted (Estimate)

August 12, 2002

Study Record Updates

Last Update Posted (Estimate)

January 24, 2013

Last Update Submitted That Met QC Criteria

January 22, 2013

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D-0007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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