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

September 18, 2014 updated by: Indiana University School of Medicine
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients from the Bone Marrow Transplant service at the Indiana University Melvin and Bren Simon Cancer Center.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
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
Procedure: collection of peripheral blood and apheresis samples
Sixty mL of peripheral blood will be collected from consenting eligible donors. Additionally, after the laboratory techniques have been fully evaluated, leukopheresis samples will also be collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To develop the optimum conditions for activating the maximum number of alloreactive T cells from clinical scale samples
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University School of Medicine

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Sherif Farag, MD, PhD, Indiana University Melvin and Bren Simon Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Anticipated)

January 1, 2010

Study Completion (Anticipated)

January 1, 2010

Study Registration Dates

First Submitted

August 7, 2008

First Submitted That Met QC Criteria

August 7, 2008

First Posted (Estimate)

August 11, 2008

Study Record Updates

Last Update Posted (Estimate)

September 19, 2014

Last Update Submitted That Met QC Criteria

September 18, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0612-01/ IUCRO-0180

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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