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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00731705
First received: August 7, 2008
Last updated: February 4, 2010
Last verified: February 2010

August 7, 2008
February 4, 2010
January 2007
January 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00731705 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
In-Vitro Studies in Depletion of Haplotype Mismatched Alloreactive T Cells
In-Vitro Studies in Depletion of Haplotype Mismatched Alloreactive T Cells

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

peripheral blood, apheresis samples

Non-Probability Sample

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

  • Hematologic Malignancies
  • Hematopoietic 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.
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
Intervention: Procedure: collection of peripheral blood and apheresis samples
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
25
January 2010
January 2010   (final data collection date for primary outcome measure)

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:

-

Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00731705
0612-01/ IUCRO-0180
Yes
Sherif Farag, MD, PhD, IU Simon Cancer Center
Indiana University School of Medicine
National Institutes of Health (NIH)
Principal Investigator: Sherif Farag, MD, PhD Indiana University Melvin and Bren Simon Cancer Center
Indiana University
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP