Overview

Azacitidine Maintenance Therapy After Allogeneic Bone Marrow Transplantation (Allo BMT)

Status:
Completed
Trial end date:
2010-08-01
Target enrollment:
0
Participant gender:
All
Summary
Primary Objective: -To determine the dose and schedule combination of 5-Azacitidine, when used as maintenance treatment after allogeneic transplantation for high-risk AML / MDS. Secondary Objective: -To assess the effect of treatment on survival after allogeneic transplantation for high-risk AML / MDS.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Celgene Corporation
Treatments:
Azacitidine
Criteria
Inclusion Criteria:

1. Patients with a diagnosis of AML (WHO classification: >=20% blasts in the bone marrow
and / or peripheral blood), or MDS (IPSS intermediate-2 or higher) that at the time of
allogeneic transplantation were in.

2. Induction Failure, relapsed disease or second or greater remission.

3. Patients in first complete remission that required more than 2 cycles of treatment to
achieve the remission.

4. Donor: HLA-compatible related (HLA-A, -B, -DRB1 matched or with one-antigen mismatch)
or

5. HLA-compatible unrelated (HLA-A, -B, -C and -DRB1 matched or with one-antigen
mismatch)

6. Age 18 to 75 years and

7. Left ventricular ejection fraction >40% and

8. FEV1, FVC and DLCO >40% and

9. Serum creatinine <1.6 mg/dL and

10. Serum bilirubin < 1.6 mg/dL and

11. SGPT < 3 X upper limit of normal and

12. All patients and donors or guardian should be able to understand and sign informed
consent.

13. Women of childbearing potential (any female who has experienced menarche, and who has
not undergone surgical sterilization or is not post-menopausal) must have a negative
serum pregnancy test.

Exclusion Criteria:

1. HIV positive

2. AML or MDS in first complete remission (defined as: bone marrow with less than 6%
blasts, no circulating blasts, and a platelet count greater than 100,000 /mm^3.)

3. Active uncontrolled infection

4. Pregnancy or breastfeeding