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The Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo and Best Supportive Care in Subjects With Red Blood Cell (RBC) Transfusion-Dependent Anemia and Thrombocytopenia Due to International Prognostic Scoring System (IPSS) Low Risk Myelodysplastic Syndrome (MDS)

Status
Completed
Cancer Type
Cancer-Related Syndrome
Leukemia
Myelodysplastic Syndromes (MDS)
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT01566695
Protocol IDs
AZA-MDS-003 (primary)
2012-002471-34
Study Sponsor
Celgene

Summary

Evaluation of the Efficacy and Safety of Oral Azacitidine plus Best Supportive care
versus Placebo and Best Supportive care in subjects with red blood cell (RBC)
transfusion-dependent anemia and thrombocytopenia due to International Prognostic Scoring
System (IPSS) lower risk myelodysplastic syndromes (MDS).

Eligibility

  1. 18 years or older
  2. Have a documented diagnosis of MDS
  3. Anemia that requires red blood cell transfusions
  4. Thrombocytopenia (sustained for at least 21 days) within 14 days prior to randomization
  5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  6. Must agree to follow pregnancy precautions as required by protocol.
  7. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted

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