Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent GVHD After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer
This study is for patients with a blood condition or myelodysplasia (bone marrow disease)
which has either not responded to treatment or is not treatable by conventional/routine
medical treatments. Bone marrow transplantation is a medical treatment that involves giving
high doses of chemotherapy followed by the transplantation of the blood-forming and immune
cells from a relative or from a "matched" unrelated person through the National Marrow Donor
Program, in an attempt to cure disease in the recipient (the person receiving the donated
cells). Nonmyeloablative (bone-marrow preservation) bone marrow transplantation is a
relatively new technique in which lower than usual doses of chemotherapy are given before
transplantation, in hopes of reducing adverse side effects of the chemotherapy in transplant
patients. Nonmyeloablative bone marrow transplantation has several advantages which doctors
have determined are beneficial for this condition.
This research is being done because the complication of graft-versus-host disease can be bad
for a person and there is no completely safe and effective way to prevent this complication.
We know that cyclosporine helps but would like to know if the addition of basiliximab,
given with cyclosporine, will decrease the incidence and/or severity of graft-versus-host
disease after a transplant known as nonmyeloablative or "mini" transplant.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Assess the incidence grade 3-4 aGVHD; Compare the incidence of grade 3-4 aGVHD with those of a recently completed clinical trial cohort
Pre-Transplant thru 1 year post transplant
Yes
Robert Nelson, MD
Principal Investigator
Indiana University School of Medicine
United States: Institutional Review Board
0908-04; IUCRO-0256
NCT00975975
September 2009
October 2014
Name | Location |
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Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |