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

18 Years
Not Enrolling
Hematologic Malignancies, Hematopoietic Stem Cell Transplantation

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Trial Information

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

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.

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

- 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:


Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

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

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Sherif Farag, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University Melvin and Bren Simon Cancer Center


United States: Institutional Review Board

Study ID:

0612-01/ IUCRO-0180



Start Date:

January 2007

Completion Date:

January 2010

Related Keywords:

  • Hematologic Malignancies
  • Hematopoietic Stem Cell Transplantation
  • Neoplasms
  • Hematologic Neoplasms