CLINICAL TRIAL SUMMARY

MDACC Study No:2005-0695 (clinicaltrials.gov NCT No: NCT00475384)
Title:Delayed Infusion of Ex Vivo Anergized Peripheral Blood Mononuclear Cells Following CD34 Selected Peripheral Blood Stem Cell Transplant From A Haploidentical Donor For Patients With Acute Leukemia and Myelodysplasia
Principal Investigator:Richard E. Champlin
Treatment Agent:Fludarabine; Radiation; Thiotepa
Study Status:Terminated
Study Description:The goal of this clinical research study is to find out if donor lymphocytes
treated with anti-B7 antibodies can be given safely after a "haploidentical"
stem cell transplant from a relative whose cell type is not fully "compatible"
with yours. The effectiveness of this treatment on immune recovery will also
be studied.

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Disease Group:Leukemia
Phase of Study:Phase I
Treatment Agents:Fludarabine
Radiation
Thiotepa
Treatment Location:Independent Multicenter Arrangements
Estimated Length of Stay in Houston:Hospitalization for transplant is expected to last 4-7 weeks. Patients may
require readmissions if complications occur.
Supported By:N/A
Return Visit:After discharge patients will be followed on a daily basis. The frequency of
visits may change as clinically indicated.
Home Care:Patients may receive home care as clinically indicated.


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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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