Decitabine Versus Supportive Care in Adults With Advanced-stage MDS (NCT00043381) | Clinical Trial Compass
CompletedPhase 3
Decitabine Versus Supportive Care in Adults With Advanced-stage MDS
United States160 participantsStarted 2001-04
Plain-language summary
To compare the safety and efficacy profiles of decitabine to those of supportive care in adults with advanced-stage myelodysplastic syndrome (MDS)
Who can participate
Age range18 Years
SexALL
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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 c…