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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: Active Phase 1 study of Chronic Graft Versus Host Disease and Steroid Refractory Graft Versus Host Disease, sponsored by City of Hope Medical Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Toxicity will be graded according to the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v.5.0).
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 |
What the registry record for NCT04212416 still lists
NCT04212416 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 116-participant average among 30 other Chronic Graft Versus Host Disease trials with a reported enrollment target (84% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Chronic Graft Versus Host Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04212416's enrollment target sits among peer trials
18 27th of 30 higher than 3 of 30 other Chronic Graft Versus Host Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Graft Versus Host Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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