Overview

Trial of Myeloablative Conditioning & Transplantation of Partially Human Leukocyte Antigen (HLA)-Mismatched Marrow With Post-transplant Cyclophosphamide for Peds Pts w/ Hematologic Malignancies

Status:
Completed

Trial end date:
2020-10-01

Target enrollment:

Participant gender:

Summary

We propose a multi-institutional phase II haplo-identical T cell replete bone marrow transplant (BMT) study in children with high-risk leukemia. The myeloablative conditioning regimen prescribed will be Total body irradiation (TBI)-based for lymphoid leukemia and busulfan-based for myeloid leukemia. Our goal is to establish an easily exportable, inexpensive platform for haplotransplantation that has a safety profile equivalent to matched related and unrelated BMTs. The primary objective will be to estimate the incidence of 6-month non-relapse mortality (NRM), hypothesizing that NRM is < 18%.

Phase:

Phase 2

Details

Lead Sponsor:

Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Treatments:

Busulfan
Cyclophosphamide
Mycophenolate mofetil
Mycophenolic Acid
Tacrolimus