Overview

5-Azacytidine Prior to Allogeneic Stem Cell Transplant in High Risk Myelodysplastic Syndrome

Status:
Completed
Trial end date:
2014-06-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to examine the feasibility and efficacy of using the demethylating agent 5-Azacytidine prior to allogeneic stem cell transplantation in patients with high risk myelodysplastic syndrome (MDS).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Virginia Commonwealth University
Collaborator:
Celgene Corporation
Treatments:
Azacitidine
Criteria
Inclusion Criteria:

- Patients fulfilling the following criteria will be eligible for study entry:

1. Diagnosis of MDS according to WHO criteria

2. Intermediate-2 or high risk by IPSS score

3. Clinically able to receive 5-Azacytidine

4. Serum bilirubin levels laboratory (ULN). Higher levels are acceptable if these can be attributed to
active hemolysis or ineffective erythropoiesis

5. Serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic
transaminase (SGPT) levels
6. Serum creatinine levels
7. Negative serum pregnancy test prior to 5-Azacytidine treatment for women of
childbearing potential

8. Women and men of childbearing potential agree to use contraception while
receiving treatment with 5-Azacytidine

9. Potentially eligible for allogeneic transplantation

10. No prior allogeneic transplant

11. Age 18 to 70, inclusive.

Exclusion Criteria:

1. Known or suspected hypersensitivity to 5-azacytidine or mannitol

2. Patients previously treated with 5-azacytidine or deoxyazacytidine

3. Pregnant or breast feeding

4. Patients with advanced malignant hepatic tumors