NCT02660281

URMC Related Haplo-identical Donor BMT

Haploidentical Donor Hematopoietic Stem Cell Transplantation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 6 Months – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will be a single-center treatment protocol, designed to validate the process of related donor haploidentical-SCT at the Wilmot Cancer Institute Blood and Marrow Transplant Unit.

Detailed description

This study will be a single-center treatment protocol with five possible preparative regimens, designed to validate the process of related donor haploidentical-SCT at the Wilmot Cancer Institute Blood and Marrow Transplant Unit. Enrolled patients will receive chemotherapy +/- radiation as a pre-transplant conditioning regimen. Patients will then receive haploidentical stem cells, either bone marrow or mobilized peripheral blood, followed by GvHD prophylaxis that will include cyclophosphamide. Multiple data points will be collected prior to, during, and following transplantation to ensure safety of the process and to evaluate the stated objectives.

Conditions

• Hematological Disease
• Immune Deficiencies
• Solid Tumors
• Myelofibrosis
• Multiple Myeloma
• Lymphoma

Interventions

Type	Name	Description
RADIATION	Total Body Irradiation 1200 cGy	1200 cGy TBI in 8 fractions
DRUG	Fludarabine	Fludarabine
DRUG	Pre-Stem Cell Infusion Cyclophosphamide	Cyclophosphamide given prior to the stem cell infusion
DRUG	Pre-Stem Cell Infusion Mesna	Mesna given prior to the stem cell infusion
DRUG	Busulfan	Busulfan
DRUG	Melphalan	Melphalan
PROCEDURE	Stem Cell Infusion	Stem cell infusion
DRUG	Post-Stem Cell Infusion Cyclophosphamide	Cyclophosphamide given after the stem cell infusion
DRUG	Post-Stem Cell Infusion Mesna	Mesna given after the Stem Cell Infusion
DRUG	Thiotepa	Thiotepa

Timeline

• Start date: 2015-10-01
• Primary completion: 2019-10-28
• Completion: 2021-01-07
• First posted: 2016-01-21
• Last updated: 2021-11-03

Locations

1 site across 1 country: United States