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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 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.

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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.

Conditions Studied

Hematopoietic and Lymphoid System Neoplasm Acute-graft-versus-host Disease

Interventions

  • DRUG Cholestyramine
  • DRUG Leflunomide
  • DRUG Steroid Therapy

Study Locations (1)

California

  • City of Hope Medical Center - Duarte

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2023-06-16
Est. Completion 2027-01-05
Phase Phase 1

Sponsor

City of Hope Medical Center

582 total trials

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What the Registry Record Tells You About NCT05443425

The ClinicalTrials.gov registry entry for NCT05443425 describes a study currently listed as 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 1,358-participant average among 31 other Hematopoietic and Lymphoid System Neoplasm trials with a reported enrollment target (99% 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 Hematopoietic and Lymphoid System Neoplasm appearing as the primary indexed condition, and to 3 interventions - of which Cholestyramine is the first listed.

NCT05443425 reports 1 study location spanning 1 distinct geographic area - top geographies include 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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