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NCT02133924 · ClinicalTrials.gov registry record · Phase 2
Multicenter Study Of Natalizumab Plus Standard Steroid Treatment For High Risk Acute Graft-Versus-Host Disease
A Phase 2 study, sponsored by John Levine.
- Completed
- Registry status
- Phase 2
- Development phase
- 76
- Enrollment target
NCT02133924 is a Phase 2 study that has completed, run by John Levine. The registered enrollment target is 76 participants.
The verdict
NCT02133924, a Phase 2 study, has completed, sponsored by John Levine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 76 participants
- Enrollment target
Study Summary
This research trial is designed to study the safety and effectiveness of combining the study drug, Natalizumab (Tysabri®) with the standard treatment, the use of steroids, as a new treatment for acute graft versus host disease (acute GVHD). GVHD is the most common serious complication, after bone marrow transplant. GVHD occurs when the donor cells (the graft), treat the recipient's body as "foreign" and attack the cells in the recipient's body. During this immune system response, donor cells damage body tissues, such as the skin, liver, stomach, and/or intestines. Acute GVHD can be severe and if severe, potentially fatal to the transplant recipient. Acute GVHD usually happens within the first several months after transplant. The goal of this research is to develop a safer and more effective treatment for acute GVHD, and particularly for acute GVHD that affects the gastrointestinal (or GI) tract, with the ultimate goal being safer and more effective transplant therapies for blood cancers such as leukemia, lymphoma, and multiple myeloma.
Interventions
- DRUG natalizumab
- DRUG steroids
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2016-08 |
| Est. Completion | 2021-11-21 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02133924
The ClinicalTrials.gov registry entry for NCT02133924 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 76 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is John Levine, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which natalizumab is the first listed.
NCT02133924 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02133924 about?
NCT02133924 is a clinical study titled "Multicenter Study Of Natalizumab Plus Standard Steroid Treatment For High Risk Acute Graft-Versus-Host Disease". This research trial is designed to study the safety and effectiveness of combining the study drug, Natalizumab (Tysabri®) with the standard treatment, the use of steroids, as a new treatment for acute graft versus host disease (acute GVHD). GVHD is the most common serious complication, after bone ma...
What is the current status of trial NCT02133924?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 76 participants. The study started on 2016-08. Estimated completion is 2021-11-21.
What interventions are being tested in trial NCT02133924?
The interventions under investigation include: natalizumab (DRUG), steroids (DRUG).
Who is sponsoring clinical trial NCT02133924?
This trial is sponsored by John Levine, which has 5 total clinical trials registered on ClinicalTrials.gov.
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