Clinical Trials Directory

Trials / Completed

CompletedNCT01523223

Donor Peripheral Stem Cell Transplant in Treating Patients With Hematolymphoid Malignancies

A Phase I Study of CD8 Memory T-Cell Donor Lymphocyte Infusion for Relapse of Hematolymphoid Malignancies Following Matched Related Donor Allogeneic Hematopoietic Cell Transplantation

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
16 (actual)
Sponsor
Robert Lowsky · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

This phase 1 trial studies the side effects and the best dose of donor CD8+ memory T-cells in treating patients with hematolymphoid malignancies. Giving low dose of chemotherapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-cancer effects). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect

Detailed description

PRIMARY OBJECTIVES: I. To determine the feasibility of purifying allogeneic CD8+ memory T-cells suitable for clinical application and to determine the safety and maximum tolerated dose (MTD) of these cells in patients with recurrent or refractory hematolymphoid malignancies following allogeneic hematopoietic cell transplant (HCT). SECONDARY OBJECTIVES: I. To determine disease response, time to disease progression, event-free survival, and overall survival following treatment with allogeneic CD8+ memory T-cells. II. To assess donor specific chimerism before and at designated time points after treatment with allogeneic CD8+ memory T-cells. OUTLINE: This is a dose-escalation study. Patients undergo CD8+ memory T-cell infusion over 10 to 20 minutes.

Conditions

Interventions

TypeNameDescription
BIOLOGICALtherapeutic allogeneic lymphocytesUndergo CD8 memory T-cell infusion

Timeline

Start date
2012-01-01
Primary completion
2016-09-01
Completion
2016-10-01
First posted
2012-02-01
Last updated
2023-11-22

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01523223. Inclusion in this directory is not an endorsement.