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NCT04212416 · ClinicalTrials.gov registry record · Phase 1
Leflunomide in Treating Patients With Steroid Dependent Chronic Graft Versus Host Disease
A Phase 1 study of Chronic Graft Versus Host Disease and Steroid Refractory Graft Versus Host Disease, sponsored by City of Hope Medical Center.
- Active
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT04212416 is a Phase 1 study of Chronic Graft Versus Host Disease and Steroid Refractory Graft Versus Host Disease that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 18 participants, below the 116-participant average among 30 other Chronic Graft Versus Host Disease trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04212416, a Phase 1 study of Chronic Graft Versus Host Disease and Steroid Refractory Graft Versus Host Disease, is active but no longer recruiting, sponsored by City of Hope Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies the side effects of leflunomide in treating patients with steroid dependent chronic graft versus host disease (cGVHD). cGVHD is a common complication of bone marrow transplant. GVHD occurs when immune cells transplanted from a donor (the graft) recognize the transplant recipient (the host) as foreign, and cause damage to the skin, gastrointestinal tract or other organs. Steroids are the first line of therapy and benefits are seen in about one-third of patients with cGVHD. Prolonged use of steroids is associated with multiple complications. Leflunomide may decrease the body's immune response and reduce inflammation associated with cGVHD.
Conditions Studied
Interventions
- DRUG Leflunomide
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2020-05-12 |
| Est. Completion | 2026-06-22 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04212416
The ClinicalTrials.gov registry entry for NCT04212416 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 30 other Chronic Graft Versus Host Disease trials with a reported enrollment target (84% lower). The listed sponsor is City of Hope Medical Center, which has 582 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Chronic Graft Versus Host Disease appearing as the primary indexed condition, and to 1 intervention - of which Leflunomide is the first listed.
NCT04212416 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT04212416 about?
NCT04212416 is a clinical study titled "Leflunomide in Treating Patients With Steroid Dependent Chronic Graft Versus Host Disease". This phase I trial studies the side effects of leflunomide in treating patients with steroid dependent chronic graft versus host disease (cGVHD). cGVHD is a common complication of bone marrow transplant. GVHD occurs when immune cells transplanted from a donor (the graft) recognize the transplant rec...
What is the current status of trial NCT04212416?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2020-05-12. Estimated completion is 2026-06-22.
What conditions does trial NCT04212416 study?
This clinical trial studies the following conditions: Chronic Graft Versus Host Disease, Steroid Refractory Graft Versus Host Disease.
What interventions are being tested in trial NCT04212416?
The interventions under investigation include: Leflunomide (DRUG).
Who is sponsoring clinical trial NCT04212416?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04212416 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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