At a glance
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A Pilot Study to Assess Engraftment Using CliniMACS TCR-α/β and CD19 Depleted Stem Cell Grafts From Haploidentical Donors for Hematopoietic Progenitor Cell Transplantation (HSCT) in Patients With Relapsed Lymphoma
In Brief
A clinical study evaluating Fludarabine Phosphate, Mesna, and 8 other interventions for Lymphoma. Completed, enrolled 11 participants across 1 site.
Detailed Summary
To determine engraftment of neutrophils and platelets at 28 days following alpha/beta T-cell and CD19 cell depletion using Human Leukocyte Antigen (HLA) haploidentical donors for peripheral blood stem cell transplant in relapsed lymphoma. Assess incidence of acute Graft Versus Host Disease (GVHD), chronic GVHD, graft failure rate, treatment related mortality rate, progression free survival and overall survival of patients. The stem cell product will be processed using an investigational Miltenyi cell selection device/system that removes the alpha/beta T-cells and CD19+ cells, immune system cells that are more likely to cause GVHD.
Study Details
Timeline
Interventions
Fludarabine will be administered by IV over approximately 30 minutes for 4 days.
Given IV over 24 hours starting prior to cyclophosphamide
Given IV for 2 days
Undergo total lymphoid irradiation
Undergo TCR alpha-beta/DC19-depleted hematopoietic stem cell transplant
Undergo TCR alpha-beta/DC19-depleted hematopoietic stem cell transplant
Undergo TCR alpha-beta/CD19-depleted hematopoietic stem cell transplant
Given PO
Given PO or IV ONLY if graft cell content is over 1 x 10\^5 cells/kg ideal BW of the patient
Given IV ONLY if graft B cell content exceeds 1 x 10\^5 cells/kg ideal BW of the patient