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Two Step Haplo With Radiation Conditioning
Sponsor: Thomas Jefferson University
Summary
This phase II clinical trial evaluates whether a modified modality of conditioning reduces treatment-related mortality (TRM) in patients who undergo a hematopoietic stem cell transplant (HSCT) for a hematological malignancy. HSCT is a curative therapy for many hematopoietic malignancies, however this regimen results in higher rates of TRM than other forms of treatment. In recent years, less intense conditioning regimens with radiation and chemotherapy prior to HSCT have been developed. Radiation therapy uses high energy sources to kill cancer cells and shrink tumors while chemotherapy drugs like fludarabine and cyclophosphamide work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This study evaluates whether a two-step approach with lower-intensity regimens of these treatments prior to HSCT reduces the rate of TRM.
Official title: A 2 Step Approach to Haploidentical Transplant Using Radiation-Based Reduced Intensity Conditioning
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
63
Start Date
2021-10-25
Completion Date
2032-04
Last Updated
2025-10-30
Healthy Volunteers
No
Conditions
Interventions
Fludarabine
Given IV
Total-Body Irradiation
Undergo TBI
Donor Lymphocyte Infusion
Undergo DLI
Cyclophosphamide
Given IV
Tacrolimus
Given IV
Mycophenolate Mofetil
Given IV
Hematopoietic Cell Transplantation
Undergo HSCT
Melphalan
Given IV
Bone Marrow Aspiration and Biopsy
Undergo bone marrow aspiration/ biopsy
Diagnostic Imaging
Undergo diagnostic imaging
Biospecimen Collection
Undergo blood sample collection
Locations (1)
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadephia, Pennsylvania, United States