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

Hematologic Malignancies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00731705
• Other study ID #: 0612-01/ IUCRO-0180
• Status: Withdrawn
• Phase: N/A
• First received: August 7, 2008
• Last updated: September 18, 2014
• Start date: January 2007
• Est. completion date: January 2010

Study information

• Verified date: September 2014
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hematologic Malignancies
• Hematopoietic Stem Cell Transplantation

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University School of Medicine	National Institutes of Health (NIH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To develop the optimum conditions for activating the maximum number of alloreactive T cells from clinical scale samples		5 years	No
Secondary	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	No

External Links

•   Click "Leukemia (Adult)"