Decitabine Versus Supportive Care in Adults With Advanced-stage MDS - Tabular View

Tracking Information
First Received Date ^ICMJE	August 8, 2002
Last Updated Date	October 12, 2009
Start Date ^ICMJE	April 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00043381 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Decitabine Versus Supportive Care in Adults With Advanced-stage MDS
Official Title ^ICMJE	A Randomized, Open-label, Phase III Trial of Decitabine (5-aza-2'Deoxycytidine) Versus Supportive Care in Adults With Advanced-stage Myelodysplastic Syndrome
Brief Summary	To compare the safety and efficacy profiles of decitabine to those of supportive care in adults with advanced-stage myelodysplastic syndrome (MDS)
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 Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Myelodysplastic Syndrome
Intervention ^ICMJE	Drug: decitabine (5-aza-2'deoxycytidine)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	160
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00043381
Responsible Party
Study ID Numbers ^ICMJE	D-0007
Study Sponsor ^ICMJE	SuperGen
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	SuperGen
Verification Date	December 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP