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Clinical Trial Summary

The purpose of this study is to compare the effects (good and bad) of the medication basiliximab in combination with cyclosporine (investigational therapy) for the prevention of a complication of bone marrow transplantation known as graft-versus-host disease (GVHD). GVHD is a complication in which the cells of the transplanted bone marrow react against organs and tissues.


Clinical Trial Description

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. ;


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Acute Lymphocytic Leukemia
  • Acute Myelogenous Leukemia
  • Anemia, Aplastic
  • Chronic Lymphocytic Leukemia
  • Chronic Myelogenous Leukemia
  • Hemoglobinuria
  • Hemoglobinuria, Paroxysmal
  • Hodgkin Disease
  • Hodgkin's Disease
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid
  • Leukemia, Myeloid, Acute
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Myelodysplasia
  • Myelodysplastic Syndromes
  • Myelofibrosis
  • Non-Hodgkin's Lymphoma
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Preleukemia

NCT number NCT00975975
Study type Interventional
Source Indiana University
Contact
Status Completed
Phase Phase 2
Start date September 2009
Completion date November 2013

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