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NCT03546556 · ClinicalTrials.gov registry record · Early Phase 1
18-FLT PET/MR Imaging to Predict Graft Failure and GVHD in Bone Marrow Transplant Patients
A Early Phase 1 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
NCT03546556 is a Early Phase 1 study that was terminated before completion, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 10 participants.
The verdict
NCT03546556, a Early Phase 1 study, was terminated before completion, sponsored by UNC Lineberger Comprehensive Cancer Center.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
Allogeneic HSCT is potentially curative for numerous high risk hematologic malignancies and offers several advantages over traditional chemotherapy. First, higher doses of cytotoxic chemotherapy and/or irradiation can be given since patients are subsequently rescued from the severe myelosuppression induced by the pre-transplant conditioning regimen by the infusion of healthy hematopoietic stem cells. Second and perhaps more importantly, mature T cells contained in the graft are able to mount immune responses against residual cancer cells surviving the conditioning regimen due to major and/or minor MHC disparities between the donor and recipient. Unfortunately, the allo-immune responses driving the GVL effect are typically not specific for malignant cells. As a consequence, donor immune cells attack normal host tissues resulting in a process known as acute graft-versus-host disease (GVHD). Acute GVHD is primarily T cell driven, usually occurs within the first few months after transplant, and results in skin rash, diarrhea, cholestatic liver damage, and, on occasion, acute lung injury.
Interventions
- DRUG Fluorothymidine (FLT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2017-01-01 |
| Est. Completion | 2020-03-12 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03546556
The ClinicalTrials.gov registry entry for NCT03546556 describes a study currently listed as terminated, categorized as Early Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 366 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Fluorothymidine (FLT) is the first listed.
NCT03546556 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03546556 about?
NCT03546556 is a clinical study titled "18-FLT PET/MR Imaging to Predict Graft Failure and GVHD in Bone Marrow Transplant Patients". Allogeneic HSCT is potentially curative for numerous high risk hematologic malignancies and offers several advantages over traditional chemotherapy. First, higher doses of cytotoxic chemotherapy and/or irradiation can be given since patients are subsequently rescued from the severe myelosuppression ...
What is the current status of trial NCT03546556?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2017-01-01. Estimated completion is 2020-03-12.
What interventions are being tested in trial NCT03546556?
The interventions under investigation include: Fluorothymidine (FLT) (DRUG).
Who is sponsoring clinical trial NCT03546556?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
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