drugset / Trial / NCT00003056

Prevention of Graft-Versus-Host Disease in Patients With Advanced Leukemia or Lymphoma Who Are Eligible for Peripheral Stem Cell Transplantation

NCT00003056

Phase 3 Terminated 105 enrolled Baxalta now part of Shire
RandomizedParallel-groupSupportive care

Summary

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. Sometimes the transplanted cells can make an immune response against the body's normal tissues. PURPOSE: Randomized phase III trial to compare the effectiveness of cyclosporine plus methotrexate with cyclosporine plus T cell depletion for prevention of graft-versus-host disease during peripheral stem cell transplantation in patients who have advanced leukemia or lymphoma who are eligible for transplanted peripheral stem cells from a donor.

Timeline

Start
1997-04-01
Primary completion
2003-06-01
Completion
2003-06-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Methotrexate Small molecule Intravenous
Background Cyclosporine Peptide Intravenous