In-Vitro Studies in Depletion of Haplotype Mismatched Alloreactive T Cells

Withdrawn

• Conditions: Hematologic Malignancies; Hematopoietic Stem Cell Transplantation
• Interventions: Procedure: collection of peripheral blood and apheresis samples

• Registration Number: NCT00731705
• Lead Sponsor: Indiana University School of Medicine

Brief Summary

The doctors in the Bone Marrow Transplant Service at the Indiana University Cancer Center are working to better understand how the immune cells that cause graft-versus-host disease (a major complication of stem cell transplantation in which the donor immune cells attack the patient's organs) can be selectively removed from the graft, leaving other immune cells that fight infections.

Detailed Description

The purpose of this research is to study how immune cells (called T cells) that cause graft-versus-host disease (GVHD) can best be selectively separated from other T cells and removed from the cells that will be returned to the cancer patient's body. These other T cells may protect against infection when given to patients after a stem cell transplant. The removal of cells that cause GVHD would allow doctors to safely give back the T cells that protect against infection, without the risk of GVHD.

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2008-08-07
• Study First Submitted QC: 2008-08-07
• Study First Posted: 2008-08-11
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-18
• Last Update Posted: 2014-09-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients with hematological malignancies who are undergoing evaluation for autologous or allogeneic stem cell transplants will be eligible, if: (1)They have no circulating neoplastic cells in the peripheral blood as assessed by routine morphology or flow cytometry. (2)Patients with acute myeloid or lymphocytic leukemia are in complete remission
• First-degree relatives of patients evaluated for stem cell transplantation will be eligible if: (1) Willing to undergo testing for HIV and hepatitis B and C (free of charge) (2) Not pregnant at time of collection of blood (3)In good general health (4) No prior history of malignancy. (5) Age 18 years or older if donating apheresis product. (Because of the relatively invasive nature of the leukopheresis procedure and difficulties in obtaining consent, children <18 who are first degree relatives of the patient will not undergo apheresis for studies on this protocol)
• Written informed consent

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	collection of peripheral blood and apheresis samples	Patients with hematological malignancies who are undergoing evaluation for autologous or allogeneic stem cell transplants OR First-degree relatives of patients evaluated for stem cell transplantation

Primary Outcome Measures

Name	Time	Method
To develop the optimum conditions for activating the maximum number of alloreactive T cells from clinical scale samples	5 years

Secondary Outcome Measures

Name	Time	Method
To develop a GMP grade high throughput, flow through immunomagnetic cell separation system for clinical scale depletion of alloreactive T cell, capable of t3log10 depletion of alloreactivity while retaining >80% third party reactivity.	5 years