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

Sponsor:	Indiana University School of Medicine
Collaborator:	National Institutes of Health (NIH)
Information provided by:	Indiana University
ClinicalTrials.gov Identifier:	NCT00731705

Purpose

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.

Condition	Intervention
Hematologic Malignancies Hematopoietic Stem Cell Transplantation	Procedure: collection of peripheral blood and apheresis samples

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	In-Vitro Studies in Depletion of Haplotype Mismatched Alloreactive T Cells

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Indiana University:

Primary Outcome Measures:

To develop the optimum conditions for activating the maximum number of alloreactive T cells from clinical scale samples [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

peripheral blood, apheresis samples

Estimated Enrollment:	25
Study Start Date:	January 2007
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

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

Criteria

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:

-

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00731705

Sponsors and Collaborators

Indiana University School of Medicine

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Sherif Farag, MD, PhD

Indiana University Melvin and Bren Simon Cancer Center

More Information

No publications provided

Responsible Party:	Sherif Farag, MD, PhD, IU Simon Cancer Center
ClinicalTrials.gov Identifier:	NCT00731705 History of Changes
Other Study ID Numbers:	0612-01/ IUCRO-0180
Study First Received:	August 7, 2008
Last Updated:	February 4, 2010
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases

ClinicalTrials.gov processed this record on February 09, 2012