At a glance
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A Two Step Approach To Allogeneic Hematopoietic Stem Cell Transplantation for Hematologic Malignancies From HLA Partially-Matched Related Donors
In Brief
A Phase 2 clinical trial evaluating Total Body Irradiation (TBI), Donor Lymphocyte Infusion (DLI), and 4 other interventions for Hematologic Malignancies. Completed, enrolled 27 participants across 1 site.
Detailed Summary
The purpose of this study is to develop a way of treating patients who do not have a completely matched family donor or a readily available unrelated donor with bone marrow transplant by using a partially-matched family donor. Patients receiving this type of transplant will receive chemotherapy and/or radiation to treat their disease. They will also receive their donor's cells in 2 parts. During the first part, the donor's lymphocytes will be exposed to one of the chemotherapy agents to help the patient become tolerant to the lymphocytes. In the second part of the transplant, the patient will receive their donor's stem cells to help recover their peripheral blood counts and establish long-term engraftment. The hypothesis of this study is that in partially-matched allogeneic transplant, there is a defined number of donor T-cells that can be treated and given to the recipient to avoid post-transplant infection without causing severe graft-versus-host disease.
Study Details
Timeline
Interventions
TBI twice daily days 6-9 prior to transplant (HSCT)
DLI given 6 days prior to transplant (HSCT).
Cyclophosphamide given once daily at 60 mg/kg on days 2 and 3 prior to transplant (HSCT).
Tacrolimus given one day prior to transplant (HSCT).
MMF given one day prior to transplant (HSCT).
CD34+ selected Hematopoietic Stem Cell Transplant (HSCT) is performed. This is the day of transplantation.