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NCT00871702 · ClinicalTrials.gov registry record · Phase 1
Infusion of Genetically Modified T Cell for Post Transplant Patients With Relapsed Disease
A Phase 1 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT00871702 is a Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 12 participants.
The verdict
NCT00871702, a Phase 1 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
Primary Objective: * To determine if there is significant toxicity associated with the administration of CD34-TK75 transduced donor lymphocytes after allogeneic BMT for relapsed hematologic malignancies Secondary Objectives: * To determine if the patient develops any evidence of anti-leukemic effect from the administration of CD34-TK75 transduced donor lymphocytes * To determine if ganciclovir administration to patients who develop Graft versus Host Disease (GVHD)results in clinical improvement after infusions of CD34-TK75 transduced lymphocytes. Sub-Study Objective The primary purpose is to perform PET imaging of CD34-TK transduced allogeneic donor T cells in patients who have relapsed hematologic malignancies after allogeneic hematopoietic stem cell transplantation (SCT). At this time the limited amount of cGMP quality virus produced by the NGVL will likely permit the imaging of only 3 patients. Consequently our current objective will be to establish that the TK-expressing cells can be detected by 18FHBG-PET in patient organs relevant for performing additional studies that are currently in the planning stages and for which we are working to produce additional virus. The ultimate objective will be to use the TK substrate 18FHBG to locate the donor T cells within the recipient as they exert anti-leukemic effects, and the T cells can then be eliminated in response to in vivo administration of ganciclovir, before morbidity and mortality from GvHD occurs. We will use the imaging strategy to define patterns of T cell trafficking in humans pre and post-DLI infusion, and to determine where the cells reside while they mediate GVL in contrast to GvHD. We expect to obtain in vivo PET imaging markers predictive of GvHD before clinical symptoms occur.
Interventions
- GENETIC CD34-TK75 transduced donor lymphocytes
- RADIATION Sub Study - 18 FHBG PET/CT Scans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2010-10 |
| Est. Completion | 2012-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00871702
The ClinicalTrials.gov registry entry for NCT00871702 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which CD34-TK75 transduced donor lymphocytes is the first listed.
NCT00871702 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00871702 about?
NCT00871702 is a clinical study titled "Infusion of Genetically Modified T Cell for Post Transplant Patients With Relapsed Disease". Primary Objective: * To determine if there is significant toxicity associated with the administration of CD34-TK75 transduced donor lymphocytes after allogeneic BMT for relapsed hematologic malignancies Secondary Objectives: * To determine if the patient develops any evidence of anti-leukemic eff...
What is the current status of trial NCT00871702?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2010-10. Estimated completion is 2012-11.
What interventions are being tested in trial NCT00871702?
The interventions under investigation include: CD34-TK75 transduced donor lymphocytes (GENETIC), Sub Study - 18 FHBG PET/CT Scans (RADIATION).
Who is sponsoring clinical trial NCT00871702?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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