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A Two-Step Approach to Reduced Intensity Bone Marrow Transplant for Patients With Hematological Malignancies
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Summary
This phase II trial studies how well reduced intensity donor stem cell transplant works in treating patients with hematologic malignancies. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Giving tacrolimus and mycophenolate mofetil after the transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them. Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may boost this effect.
Official title: A Two Step Approach to Reduced Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematologic Malignancies
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2011-08-04
Completion Date
2022-11-16
Last Updated
2026-04-15
Healthy Volunteers
No
Conditions
Interventions
Fludarabine
Given IV
Busulfan
Given IV
Total Body Irradiation (TBI)
2 Gy administered as part of the conditioning regimen
Donor Lymphocyte Infusion (DLI)
Undergo DLI
Cyclophosphamide (CY)
Given IV
Tacrolimus
Given IV or PO
Mycophenolate mofetil
Given IV
Allogeneic hematopoietic stem cell transplantation
Undergo CD34+ allogeneic PBSCT
Peripheral blood stem cell transplantation (PBSCT)
Undergo CD34+ allogeneic PBSCT
Locations (1)
Thomas Jefferson University
Philadelphia, Pennsylvania, United States