Phase II Trial of Myeloablative Conditioning & Transplantation of Partially HLA-mismatched Marrow With Post-transplant Cyclophosphamide for Peds Pts w/ Hematologic Malignancies

Official Title

Pediatric Blood & Marrow Transplant Consortium (PBMTC) Multi-centre Phase II Pilot Trial of Myeloablative Conditioning and Transplantation of Partially HLA-mismatched T Cell Replete Bone Marrow With Post-transplantation Cyclophosphamide for Pediatric Patients With Hematologic Malignancies

Summary:

We propose a multi-institutional phase II haplo-identical T cell replete BMT study in children with high-risk leukemias. The myeloablative conditioning regimen prescribed will be TBI-based for lymphoid leukemias and busulfan-based for myeloid leukemias. 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, hypothesizing that NRM is < 18%.

Trial Description

Primary Outcome:

  • Incidence of Mortality
Secondary Outcome:
  • Donor Cell Engraftment
This is a phase II prospective study designed to evaluate the incidence of 6 month non- relapse mortality, safety, and feasibility of haploidentical bone marrow transplantation (BMT) after myeloablative conditioning with post-transplant Cy. Conditioning regimens include a total body irradiation-based prep for lymphoid leukemias and a chemotherapy based prep for myeloid leukemias. To estimate the incidence of non-relapse mortality at 180 days following myeloablative haploidentical BMT for children and young adults with high risk hematologic malignancies.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

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