Spots Global Cancer Trial Database for Myeloablative Haploidentical BMT With Post-transplant Cyclophosphamide for Pediatric Patients With Hematologic Malignancies
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Trial Identification
Brief Title: Myeloablative Haploidentical BMT With Post-transplant Cyclophosphamide for Pediatric Patients With Hematologic Malignancies
Official Title: Pediatric Blood & Marrow Transplant Consortium (PBMTC) Phase II Myeloablative Haploidentical BMT With Post-transplantation Cyclophosphamide for Pediatric Patients With Hematologic Malignancies
Study ID: NCT02120157
Study Description
Brief Summary: This is a multi-institutional phase II haploidentical 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%.
Detailed Description: 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 (TBI)-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.
Eligibility
Minimum Age: 6 Months
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Children's Hospital of Colorado, Aurora, Colorado, United States
Nemours Alfred I. DuPont Hospital for Children, Wilmington, Delaware, United States
All Children's Hospital Johns Hopkins Medicine, Saint Petersburg, Florida, United States
Johns Hopkins Hospital, Baltimore, Maryland, United States
Washington University in St. Louis, Saint Louis, Missouri, United States
Levine Cancer Center, Charlotte, North Carolina, United States
Medical University of South Carolina, Charleston, South Carolina, United States
British Columbia Children's Hospital, Vancouver, British Columbia, Canada
Hospital for Sick Children, Toronto, Ontario, Canada
Contact Details
Name: Heather Symons, MD, MHS
Affiliation: SKCCC Johns Hopkins Hospital
Role: PRINCIPAL_INVESTIGATOR
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