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

NCT00731705 | Withdrawn DMC

• 1 other identifier: 0612-01/ IUCRO-0180
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hematologic Malignancies; Hematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

• To develop the optimum conditions for activating the maximum number of alloreactive T cells from clinical scale samples

  5 years

Secondary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

collection of peripheral blood and apheresis samples PROCEDURE

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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

Sponsors & Collaborators

• Indiana University School of Medicine: lead
• National Institutes of Health (NIH): collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

peripheral blood, apheresis samples

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Sherif Farag, MD, PhD

  Indiana University Melvin and Bren Simon Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 7, 2008
• First Posted: August 11, 2008
• Study Start: January 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: September 19, 2014

Record last verified: 2014-09