CLINICAL TRIAL SUMMARY

MDACC Study No:2008-0087 (clinicaltrials.gov NCT No: NCT00813124)
Title:Azacitidine maintenance therapy after allogeneic stem cell transplantation for CML (VZ-CML-PI-0130)
Principal Investigator:Richard E. Champlin
Treatment Agent:ATG; Azacitidine; Busulfan; Fludarabine; G-CSF; Tacrolimus
Study Status:Terminated
Study Description:The goal of laboratory research study is to learn patterns of methylation.
Methylation is a process by which the body may turn "on and off" certain genes.
The patient who receives your stem cells will be treated with a drug that
interferes with this process and researchers will use your blood to make a
profile of your cells, which will be compared to the profile of the cells taken
from your recipient after the transplant.

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Disease Group:Blood And Marrow Transplantation; Leukemia
Phase of Study:Phase II
Treatment Agents:ATG
Azacitidine
Busulfan
Fludarabine
G-CSF
Tacrolimus
Treatment Location:Only at MDACC
Estimated Length of Stay in Houston:Transplant: approximately 30 days in the hospital. Readmissions may occur, as
clinically indicated.
Supported By:Celgene Corporation
NCI
Return Visit:Patients are to return to MDACC as clinically indicated. Usually, for 7-14 days
they will come daily, and subsequently, on a 2-3 / week basis, until transplant
day + 100. In addition, they are expected to return 6, 9 and 12 months after
transplant.
Home Care:Protocol treatment is to be given in a hospital/clinic basis.


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Physician Name:Richard E. Champlin
Dept:Stem Cell Transplantation and Cellular Therapy
For Clinical Trial Enrollment:713-792-8750
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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