Azacitidine After Allo Blood And Marrow Transplantation (BMT) for Chronic Myelogenous Leukemia (CML)

PHASE2CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

December 31, 2008

Primary Completion Date

September 30, 2014

Study Completion Date

September 30, 2014

Conditions
Stem Cell TransplantationLeukemia
Interventions
DRUG

Fludarabine

40 mg/m\^2 by vein over 60 minutes on Day -5 through Day -2.

DRUG

Busulfan

Busulfan administered at the dose calculated to achieve an area under curve (AUC) of 4000 µMol-min + 12% based on the pharmacokinetic studies (days -5, -4, -3, and -2).

DRUG

Thymoglobulin

2.5 mg/kg by vein over about 4-6 hours on Day -3 through Day -1.

DRUG

Azacitidine

Start cycles of 32 mg/m\^2 daily as an injection under the skin once a day over 5 days in a row, starting about 5 weeks after the transplant. This may be repeated once a month for up to 4 months after the transplant.

PROCEDURE

Stem Cell Transplant

Stem cell infusion on day 0 administered by vein after collected from donor.

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

Celgene Corporation

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER

NCT00813124 - Azacitidine After Allo Blood And Marrow Transplantation (BMT) for Chronic Myelogenous Leukemia (CML) | Biotech Hunter | Biotech Hunter