Overview

A Reduced Toxicity Allogeneic Unrelated Donor Stem Cell Transplantation (SCT) for Severe Sickle Cell Disease

Status:
Terminated
Trial end date:
2015-01-01
Target enrollment:
Participant gender:
Summary
Majority of patients who are eligible for allogeneic HSCT for cure of severe sickle cell disease lack a matched family donor. This study aims for cure of sickle cell disease by performing unrelated donor (outside family) allogeneic HSCT. Donors or unrelated cord blood units will be selected from the NMDP database. It is designed to estimate the safety of a novel reduced toxicity, yet an immunosuppressive and myeloablative preparative regimen. This is meant for patients <21 years old who have severe complications from sickle cell and do not have matched sibling donors in the family to undergo stem cell transplant. Patients will undergo transplant using unrelated donor stem cells after receiving the protocol therapy. They will be followed for 1 year to monitor for engraftment of donor cells and complications like graft versus host disease (GVHD), infections and death.
Phase:
Phase 2
Details
Lead Sponsor:
Nationwide Children's Hospital
Treatments:
Busulfan
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Mycophenolate mofetil
Mycophenolic Acid
Rituximab
Tacrolimus
Thymoglobulin
Vidarabine