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NCT05443425 · ClinicalTrials.gov registry record · Phase 1
Leflunomide in Combination With Steroids for the Treatment of Acute Graft-versus-Host Disease After Donor Stem Cell Transplant for Hematologic Malignancies
A Phase 1 study of Hematopoietic and Lymphoid System Neoplasm and Acute-graft-versus-host Disease, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT05443425: Recruiting Phase 1 study of Hematopoietic and Lymphoid System Neoplasm and Acute-graft-versus-host Disease, sponsored by City of Hope Medical Center.
NCT05443425 is a Phase 1 study of Hematopoietic and Lymphoid System Neoplasm and Acute-graft-versus-host Disease that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 18 participants, below the 1,358-participant average among 31 other Hematopoietic and Lymphoid System Neoplasm trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05443425, a Phase 1 study of Hematopoietic and Lymphoid System Neoplasm and Acute-graft-versus-host Disease, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial tests the safety and side effects of leflunomide in combination with steroids in treating patients with acute graft versus host disease who have undergone done stem cell transplant for blood cancers (hematologic malignancies). Sometimes the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). Leflunomide and steroids are immunosuppressive drugs that work in different ways to lower the body's immune response so that the new donor immune cells do not attack the body's normal cells. Giving leflunomide in combination with steroids may help treat acute graft versus host disease in patients after stem cell transplant for hematologic malignancies.
Primary Outcome
Toxicity will be graded according to the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events version 5.0. Unacceptable toxicity (UT) evaluation period will be from starting first loading dose of leflunomide to occurrence of UTs, or stopping leflunomide due to graft versus host disease (GVHD) progression, or day +28, whichever comes first.
Conditions Studied
Interventions
- DRUG Cholestyramine
- DRUG Leflunomide
- DRUG Steroid Therapy
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2023-06-16 |
| Est. Completion | 2027-01-05 |
| Phase | Phase 1 |
What NCT05443425 shows while recruiting
NCT05443425 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 1,358-participant average among 31 other Hematopoietic and Lymphoid System Neoplasm trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Hematopoietic and Lymphoid System Neoplasm appearing as the primary indexed condition, and to 3 interventions - of which Cholestyramine is the first listed.
NCT05443425 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05443425 about?
NCT05443425 is a clinical study titled "Leflunomide in Combination With Steroids for the Treatment of Acute Graft-versus-Host Disease After Donor Stem Cell Transplant for Hematologic Malignancies". This phase I trial tests the safety and side effects of leflunomide in combination with steroids in treating patients with acute graft versus host disease who have undergone done stem cell transplant for blood cancers (hematologic malignancies). Sometimes the transplanted cells from a donor can atta...
What is the current status of trial NCT05443425?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2023-06-16. Estimated completion is 2027-01-05.
What conditions does trial NCT05443425 study?
This clinical trial studies the following conditions: Hematopoietic and Lymphoid System Neoplasm, Acute-graft-versus-host Disease.
What interventions are being tested in trial NCT05443425?
The interventions under investigation include: Cholestyramine (DRUG), Leflunomide (DRUG), Steroid Therapy (DRUG).
Who is sponsoring clinical trial NCT05443425?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05443425 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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