Decitabine Versus Supportive Care in Adults With Advanced-stage MDS

Astex Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Myelodysplastic Syndrome

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00043381

D-0007

Details and patient eligibility

About

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

Full 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).

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.