Provision of TCRγδ T Cells and Memory T Cells Plus Selected Use of Blinatumomab in Naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies Relapsed or Refractory Despite Prior Transplantation

• Status: Recruiting
• Trial end date: 2023-07-01

Summary

This study seeks to examine treatment therapy that will reduced regimen-related toxicity and relapse while promoting rapid immune reconstitution with limited serious graft-versus-host-disease (GVHD) and also improve disease-free survival and quality of life. The investigators propose to evaluate the safety and efficacy of selective naive T-cell depleted (by TCRɑβ and CD45RA depletion, respectively) haploidentical hematopoietic cell transplant (HCT) following reduced intensity conditioning regimen that avoids radiation in patients with hematologic malignancies that have relapsed or are refractory following prior allogeneic transplantation.

PRIMARY OBJECTIVE:

• To estimate engraftment by day +30 post-transplant in patients who receive TCRɑβ-depleted and CD45RA-depleted haploidentical donor progenitor cell transplantation following reduced intensity conditioning regimen without radiation.

SECONDARY OBJECTIVES:

• Assess the safety and feasibility of the addition of Blinatumomab in the early post-engraftment period in patients with CD19+ malignancy.

• Estimate the incidence of malignant relapse, event-free survival, and overall survival at one-year post-transplantation.

• Estimate incidence and severity of acute and chronic (GVHD).

• Estimate the rate of transplant related mortality (TRM) in the first 100 days after transplantation.

• Phase: Phase 2

Details

• Lead Sponsor: St. Jude Children's Research Hospital
• Treatments: Antibodies, Bispecific; Antilymphocyte Serum; Blinatumomab; Cyclophosphamide; Fludarabine; Fludarabine phosphate; Mechlorethamine; Melphalan; Mesna; Rituximab; Sirolimus; Tacrolimus; Thiotepa; Thymoglobulin