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Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation in Subjects With Acute Myeloid Leukemia or Myelodysplastic Syndromes

Complete title: A Phase 1/2, Dose and Schedule Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Oral Azacitidine (CC-486) in Subjects with Acute Myeloid Leukemia or Myelodysplastic Syndromes after Allogeneic Hematopoietic Stem Cell Transplantation

Research Study Number       2709.00
    
Principal Investigator       Bart Scott, MD
    
Phase       I/II

Look up trial at NIH

Research Study Description

The purpose of the study is to determine the maximal tolerated dose and schedule of CC-486 (also known as oral Azacitidine) in patients with AML or MDS after allogeneic HSCT. Allogeneic hematopoietic stem cell transplantation (HSCT) is more frequently used in Acute Myloid leukemia (AML) or Myelodysplastic Syndromes (MDS) as a potential curative therapy. However, disease recurrence/relapse and graft-versus-host disease (GVHD) remain the principal causes of fatal complications after transplantation. Azacitidine has significant activity in MDS and AML. Azacitidine has also demonstrated immunomodulatory activity in AML patients after allogeneic HSCT. An oral formulation of Azacitidine provides a convenient route of administration and an opportunity to deliver the drug over a prolonged schedule.

Eligibility Criteria (must meet the following to participate in this study)

** For Eligibility information, please click on the "Look up trial at NIH" link above. **

Other eligibility criteria may apply.



Research Study Number       2709.00
    
Contact       Seattle Cancer Care Alliance Intake Office
    
Telephone       800-804-8824 / 206-288-1024
    
   

Keywords
Acute Myeloid Leukemia (AML); Hematologic Malignancies; Leukemia; Myelodysplastic and Myeloproliferative Syndromes (MDS and MPD)

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