drugset / Trial / NCT04776850

Pre-transplant Immunosuppression and Donor Stem Cell Transplant for the Treatment of Severe Hemoglobinopathies

NCT04776850

Phase 0 Withdrawn M.D. Anderson Cancer Center
NaSingle-groupOpen-labelTreatment

Summary

This clinical trial studies the effect of pre-transplant immunosuppression (PTIS) and donor stem cell transplant in treating patients with severe blood diseases (hemoglobinopathies). PTIS helps prepare the body for the transplant and lowers the risk of developing graft versus host disease (GVHD). Hematopoietic cells are found in the bone marrow and produce blood cells. Hematopoietic cell transplantation (HCT) injects healthy hematopoietic cells into the body to support blood cell production. PTIS and HCT may help to control severe hemoglobinopathies.

Timeline

Start
2020-12-29
Primary completion
2022-12-05
Completion
2022-12-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Busulfan Small molecule Intravenous
Subject Rituximab Monoclonal antibody Intravenous
Subject Thymoglobulin Protein / enzyme biologic Intravenous
Background Bortezomib Small molecule Intravenous
Background Cyclophosphamide Other / unclassified Intravenous
Background Dexamethasone Small molecule Intravenous
Background Fludarabine Small molecule Intravenous
Background Mycophenolate Mofetil Small molecule Intravenous
Background Tacrolimus Small molecule Intravenous