Clinical trial NCT00731705: In-Vitro Studies in Depletion of Haplotype Mismatched Alloreactive T Cells
Official title: In-Vitro Studies in Depletion of Haplotype Mismatched Alloreactive T Cells
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hematologic Malignancies
Hematopoietic Stem Cell Transplantation
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2008-08-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from the Bone Marrow Transplant service at the Indiana University Melvin and Bren Simon Cancer Center.

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.

Eligibility 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:

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Primary outcomes:
measure: To develop the optimum conditions for activating the maximum number of alloreactive T cells from clinical scale samples
timeFrame: 5 years
Secondary outcomes:
measure: 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.
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Indiana University Melvin and Bren Simon Cancer Center
name: Sherif Farag, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: