Decitabine Versus Supportive Care in Adults With Advanced-stage MDS

Myelodysplastic Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00043381
• Other study ID #: D-0007
• Status: Completed
• Phase: Phase 3
• First received: August 8, 2002
• Last updated: January 22, 2013
• Start date: April 2001
• Est. completion date: April 2003

Study information

• Verified date: June 2011
• Source: Astex Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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).

Other known NCT identifiers

• NCT00022061

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: April 2003
• Est. primary completion date: November 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia

Intervention

Drug:
• decitabine (5-aza-2'deoxycytidine)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Astex Pharmaceuticals

Country where clinical trial is conducted

United States,