NCT02600208

Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies with Alpha Beta TCell and B Cell Depletion Using the CliniMACS Device

BT13BTθ51 Unrelated and Partially Matched Related Donor Peripheral Stem Cell Transplantation with Alpha Beta T Cell and B Cell Depletion for Patients with Hematologic Malignancies

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Julie-An M. Talano · Academic / Other
• Sex: Female
• Age: 23 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm pilot study for patients with hematologic malignancies with alternative donor sources receiving unrelated or partially matched related/Haploidentical mobilized peripheral stem cells (PSCs) using the CliniMACS system for Alpha Beta T cell depletion plus CD19+ B cell depletion to determine efficacy as determined by engraftment and GVHD, and one year leukemia free survival.

Detailed description

The purpose of this research study is to evaluate a new method of T cell depletion using the Miltenyi CliniMACS™ device for patients undergoing a peripheral stem cell transplant utilizing either a unrelated donor or partially matched/haploidentical related donor. This new method is called α/β (alpha/beta) T cell depletion and CD19+ B cell depletion. This pilot study will evaluate if this new method of T cell and B cell depletion is a more effective way of removing T cells thus reducing the risk of severe acute and chronic GVHD and result in a durable engraftment.

Conditions

• Hematologic Malignancies

Interventions

Type	Name	Description
DEVICE	CliniMACs	Depletion of Alpha Beta T cells in the PBSC graft

Timeline

• Start date: 2015-10-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2015-11-09
• Last updated: 2025-02-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study