Decitabine Versus Supportive Care in Ad… | Clinical Trial

Key information

Conditions

Myelodysplastic Syndrome Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myelomonocytic, Chronic Myelodysplastic Syndromes Myelodysplastic-Myeloproliferative Diseases Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alta Bates Comprehensive Cancer Center, Berkeley, California, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

decitabine (5-aza-2'deoxycytidine)

Drug

Sponsors and collaborators

Lead sponsor

Astex Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2001
Primary completion: 2002
Study completion: 2003
First posted: Aug 12, 2002
Registry last updated: Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed