NCT02350777

T-cell Depleted Hematopoietic Stem Cell Boosts Without Conditioning for Poor Marrow Graft Function Following Allogeneic Hematopoietic Stem Cell Transplantation

Phase II Trial of T-cell Depleted Hematopoietic Stem Cell Boosts Without Conditioning for Poor Marrow Graft Function Following Allogeneic Hematopoietic Stem Cell Transplantation

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see if giving the patient stem cells their original donor (boost) after removing the T cells (T cell depleted- TCD boost) without further chemotherapy. The investigators want to see if this can improve bone marrow function. This would also improve the patients white blood counts, red blood counts and platelets. This may make the patients chances of improving and surviving better. The investigators will also be looking at the short term side effects and risks of the TCD boost.

Conditions

• Hematopoietic Stem Cell Transplant
• Poor Marrow Graft Function

Interventions

Type	Name	Description
PROCEDURE	Donor peripheral blood progenitor cells: stimulation, harvesting, isolation and T-cell depletion	For related donors, beginning 5-6 days before the day of HPC(A) or HPC (M) TCD boost infusion, the normal donor will receive GCSF per institutional guidelines. On the fifth and sixth days of this course of G-CSF, the donor will undergo daily leukapheresis designed to provide a minimum of 5x10\^6 CD34+ cells/kg of the transplant recipient's weight. For unrelated donors, the G-CSF will be administered and the leukapheresis obtained according to the National Marrow Donor Program protocol IND, and institutional guidelines. Mononuclear cell fractions (i.e., CD34+ cells) collected on the fourth and fifth days will be pooled.
DEVICE	CliniMACS Cell Selection System

Timeline

• Start date: 2015-01-21
• Primary completion: 2017-10-25
• Completion: 2017-10-25
• First posted: 2015-01-30
• Last updated: 2018-10-09
• Results posted: 2018-06-06

Locations

1 site across 1 country: United States