drugset / Trial / NCT00296023

Donor Stem Cell Transplant in Treating Older or Frail Patients With Hematologic Cancer

NCT00296023

Non-randomizedSingle-groupOpen-labelTreatment

Summary

RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving antithymocyte globulin before transplant and methotrexate and tacrolimus after the transplant may stop this from happening. PURPOSE: This phase I trial is studying the side effects of donor stem cell transplant in treating older or frail patients with hematologic cancer.

Timeline

Start
1999-01
Primary completion
2007-06
Completion
2008-06

Drugs

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