drugset / Trial / NCT01118013

Donor Stem Cell Transplant in Treating Patients With Relapsed Hematologic Malignancies or Secondary Myelodysplasia Previously Treated With High-Dose Chemotherapy and Autologous Stem Cell Transplant

NCT01118013

NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Giving chemotherapy, such as busulfan and fludarabine phosphate, before a peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving methotrexate, tacrolimus, and antithymocyte globulin before and after the transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them (called graft-versus-tumor effect). Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may boost this effect. PURPOSE: This phase II trial is studying how well donor stem cell transplant works in treating patients with relapsed hematologic malignancies or secondary myelodysplasia previously treated with high-dose chemotherapy and autologous stem cell transplant .

Timeline

Start
2010-12
Primary completion
2012-03
Completion
2013-08

Drugs

EvaluationDrugModalityDoseRoute
Background ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) Protein / enzyme biologic Intravenous
Background Busulfan Small molecule Intravenous
Background Fludarabine Small molecule Intravenous
Background Methotrexate Small molecule Intravenous
Background Mycophenolate Mofetil Small molecule Oral
Background Tacrolimus Small molecule Oral
Background filgrastim Protein / enzyme biologic Subcutaneous
Background therapeutic allogeneic lymphocytes Cell therapy