Overview

Pre-Transplant 5-Azacitidine In Patients With High-Risk Myelodysplastic Syndrome Who Are Candidates For Allogeneic Hematopoietic Cell Transplant

Status:
Completed
Trial end date:
2014-06-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to find out if treating people who have high-risk myelodysplastic syndrome (MDS) with 5-Azacitidine (Vidaza) prior to their allogeneic hematopoietic cell transplant (HCT) is helpful in preventing their myelodysplastic syndrome from coming back. In previous research, 5-Azacitidine appeared to help the bone marrow of a patient with MDS begin to function more normally. This means bone marrow cells can grow and do their work the way they were meant to. 5-Azacitidine is approved by the Food and Drug Administration (FDA) for the treatment of MDS. The effect of 5-Azacitidine in patients receiving hematopoietic cell transplants have not been studied.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborator:
Celgene Corporation
Treatments:
Azacitidine
Criteria
Inclusion Criteria:

- Potential candidate for HCT.

- Histologically confirmed diagnosis by pathologic review of previous diagnosis of
high-risk myelodysplastic syndrome (MDS): International Prognostic Scoring System
(IPSS) > 1 or AML-MDS or treatment related MDS.

- Serum bilirubin levels ≤1.5 times the upper limit of the normal (ULN) range for the
laboratory. Higher levels are acceptable if these can be attributed to active
hemolysis or ineffective erythropoiesis; Serum glutamic-oxaloacetic transaminase
(SGOT) [aspartate aminotransferase (AST)] or serum glutamic pyruvic transaminase
(SGPT) [alanine aminotransferase (ALT)] levels ≤2 x ULN.

- Serum creatinine levels ≤1.5 x ULN

- Karnofsky performance status greater or equal to 70%

- Signed informed consent form in accordance with institutional policies

Exclusion Criteria:

- Known or suspected hypersensitivity to Vidaza or mannitol

- Pregnant or lactating women

- Human immunodeficiency virus (HIV) or seropositive, confirmed by nucleic acid
amplification testing (NAT)

- Active central nervous system (CNS) malignancy

- Active infection

- History or presence of primary hepatoma