Clinical trial · Observational

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

NCT00731705CI-TRIAL-00015659withdrawnClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Hematologic Malignancies	Hematopoietic and Lymphoid Cell Neoplasm	PROBABILISTIC	0.70
Hematopoietic Stem Cell Transplantation	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
collection of peripheral blood and apheresis samples	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

label
1
description
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
interventionNames
1. Procedure: collection of peripheral blood and apheresis samples

Primary outcomes (1)

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

Secondary outcomes (1)

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

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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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References

Publications (0)

Data not yet available

No reference posted for this study.