Steroid Therapy for Graft-versus-Host Disease

City of Hope Medical Center, Duarte, CA
Targeting 2 different conditionsSteroid Therapy +2 morePhase 1RecruitingLed by Monzr M Al MalkiResearch Sponsored by City of Hope Medical Center

Study Summary

This trial is testing a combination of drugs to treat patients with a specific kind of cancer. The drugs are designed to lower the body's immune response so that the new donor cells don't attack the body's normal cells.

Eligible Conditions
  • Graft-versus-Host Disease
  • Blood Cancers

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You are able to perform daily activities and take care of yourself with a score of 70 or higher on the Karnofsky performance scale.
You can receive a hematopoietic cell transplant (HCT) from any donor, whether they are related or unrelated to you and regardless of the level of matching with your HLA. The source of the transplant can be from bone marrow, peripheral blood stem cells, or cord blood. This criterion applies to people with hematologic malignancies or disorders who have undergone myeloablative or reduced-intensity conditioning regimens.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Secondary outcome measures
Failure-free survival (FFS)
Incidence of bloodstream infection severity
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment of aGVHD (steroid therapy, leflunomide)Experimental Treatment3 Interventions
Patients receive steroid therapy at the discretion of the treating physician. Beginning within 3 days of starting steroids, patients receive leflunomide PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity. Patients who respond to leflunomide treatment will be tapered off from day 29 until day 56.
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 4
Completed Phase 4

Find a site

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,369 Previous Clinical Trials
41,215,247 Total Patients Enrolled
1 Trials studying Graft-versus-Host Disease
236 Patients Enrolled for Graft-versus-Host Disease
City of Hope Medical CenterLead Sponsor
536 Previous Clinical Trials
2,250,882 Total Patients Enrolled
Monzr M Al MalkiPrincipal Investigator
City of Hope Medical Center
5 Previous Clinical Trials
206 Total Patients Enrolled

Media Library

Leflunomide (Immunosuppressant) Clinical Trial Eligibility Overview. Trial Name: NCT05443425 — Phase 1
Graft-versus-Host Disease Research Study Groups: Treatment of aGVHD (steroid therapy, leflunomide)
Graft-versus-Host Disease Clinical Trial 2023: Leflunomide Highlights & Side Effects. Trial Name: NCT05443425 — Phase 1
Leflunomide (Immunosuppressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05443425 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrolment process currently active for this research?

"According to the information located on, this particular medical trial is not presently recruiting patients. This study was published December 10th 2022 and last edited June 30th 2022. While no longer enrolling participants at present, there are still 436 other studies open for recruitment right now."

Answered by AI

What potential risks accompany the use of Steroid Therapy?

"Based on our assessment, steroid therapy is considered to have a low level of safety given that this trial is only in the initial stages. Therefore we assign it a score of 1."

Answered by AI
~12 spots leftby Jul 2025