CLINICAL TRIAL SUMMARY

MDACC Study No:2008-0261 (clinicaltrials.gov NCT No: NCT00800839)
Title:Busulfan (IV) and Fludarabine followed by post-allogeneic transplantation Cyclophosphamide for Graft-versus-Host Disease Prophylaxis in patients with hematologic malignancies.
Principal Investigator:Amin Alousi
Treatment Agent:Busulfan; Cyclophosphamide; Fludarabine; Mesna
Study Status:Closed
Study Description:The goal of this clinical research study is to learn if cyclophosphamide given
after busulfan and fludarabine can help to prevent graft versus host disease
(GVHD - a condition in which transplanted tissue attacks the body into which it
is transplanted) in patients receiving a stem cell transplant. The safety of
this drug combination will also be studied.

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Disease Group:Hematologic Disorder; Leukemia; Lymphoma; Myeloma
Phase of Study:Phase II
Treatment Agents:Busulfan
Cyclophosphamide
Fludarabine
Mesna
Treatment Location:Only at MDACC
Estimated Length of Stay in Houston:Approximate 1 month hospital stay. Patients are required to stay in Houston
for the first 100 days following transplant. Patients will then be seen every
3-6months thereafter for 2 years from the date of transplant.
Supported By:N/A
Return Visit:While an outpatient and for the first 100 days following transplant, patients
will be required to come to clinic a minimum of 2 times per week. After the
first 100 days, visits are at 3, 6, 9, 12, 18 and 24 months following the date
of transplant.
Home Care:No anticipated home treatment.


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Physician Name:Amin Alousi
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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