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Study to Determine the Safety and Preliminary Efficacy of CC-1088 in the Treatment of Myelodysplastic Syndromes



Study to Determine the Safety and Preliminary Efficacy of CC-1088 in the Treatment of Myelodysplastic Syndromes

For Condition: Myelodysplastic Syndrome
Status: Completed
Sponsor(s): Celgene Corporation ,
Synopsis: The primary objective of the study is to assess the safety of CC-1088 to patients with myelodysplastic syndromes (MDS).
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/80 Years
Genders: Both
Protocol Entry Criteria: - Eligible patients must have a diagnosis of MDS of at least 12 weeks that is not therapy related. - Patient must be able to adhere to the study visit schedule and other protocol requirements. - Patient must understand and voluntarily sign an informed consent document. - Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test. - Women must not be pregnant or lactating.
Total Enrollment: 39

Location and Contact Information:

Rush-Presbyterian-St Luke's Medical Center
Chicago,  Illinois,  60612-3515
United States
 


Additional Information:
Study ID Numbers:
  CC-1088-MDS-801-001; 
Study Start Date: October 2001
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00045786

Other Myelodysplastic Syndrome Studies:
1. An open-label, phase II trial of PKC412 monotherapy in patients with acute myeloid leukemia and patients with myelodysplastic syndrome

2. Megadose CD34 Selected Progenitor Cells for Transplantation in Patients with Advanced Hematological Malignant Diseases

3. The Role of Cyclosporin in Blood Cell Transplants with T-Cell Add-Back for Blood Cancers

4. Study of High-dose Pulse Administration DN-101 (Calcitriol) in Patients with Myelodysplastic Syndrome (MDS)

5. Phase II Randomized Study of three Different Schedules of Low-Dose Decitabine in Myelodysplastic Syndrome (MDS)

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Study to Determine the Safety and Preliminary Efficacy of CC-1088 in the Treatment of Myelodysplastic Syndromes

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