drugset / Trial / NCT02652468

TCR-α/β and CD19 Depleted Stem Cell Grafts From Haplo Donors for HSCT in Relapsed Lymphoma

NCT02652468

Completed 11 enrolled University of Wisconsin, Madison
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2016-03-10
Primary completion
2018-09-01
Completion
2021-09-17

Drugs

EvaluationDrugModalityDoseRoute
Background 2-MERCAPTOETHANESULFONIC ACID Small molecule Intravenous
Background Cyclophosphamide Other / unclassified Intravenous
Background Fludarabine Small molecule Intravenous
Background Mycophenolate Mofetil Small molecule Oral
Background Rituximab Monoclonal antibody Intravenous
Background Tacrolimus Small molecule Oral

Indications