Steroid Therapy for Graft vs Host Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
City of Hope Medical Center, Duarte, CA
Graft vs Host Disease+3 More
Steroid Therapy - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions

  • Graft vs Host Disease
  • Neoplasms
  • Graft-vs-Host Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Graft vs Host Disease

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Up to 6 months

At 28 days
Overall response rate
At day 180
Non-relapse mortality (NRM)
Month 6
Failure-free survival (FFS)
Year 1
Overall survival (OS)
Year 1
Progression-free survival (PFS)
Up to 6 months
Incidence of adverse events
Incidence of bloodstream infection severity
Incidence of bloodstream infections
Total steroids and length of therapy

Trial Safety

Safety Progress

1 of 3

Other trials for Graft vs Host Disease

Trial Design

1 Treatment Group

Treatment of aGVHD (steroid therapy, leflunomide)
1 of 1
Experimental Treatment

18 Total Participants · 1 Treatment Group

Primary Treatment: Steroid Therapy · No Placebo Group · Phase 1

Treatment of aGVHD (steroid therapy, leflunomide)Experimental Group · 3 Interventions: Steroid Therapy, Leflunomide, Cholestyramine · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Leflunomide
2003
Completed Phase 4
~1660
Cholestyramine
2018
Completed Phase 4
~320

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 months
Closest Location: City of Hope Medical Center · Duarte, CA
Photo of Duarte 1Photo of Duarte 2Photo of Duarte 3
2002First Recorded Clinical Trial
11 TrialsResearching Graft vs Host Disease
142 CompletedClinical Trials

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
12,930 Previous Clinical Trials
41,294,442 Total Patients Enrolled
130 Trials studying Graft vs Host Disease
9,931 Patients Enrolled for Graft vs Host Disease
City of Hope Medical CenterLead Sponsor
501 Previous Clinical Trials
2,246,377 Total Patients Enrolled
10 Trials studying Graft vs Host Disease
556 Patients Enrolled for Graft vs Host Disease
Monzr M Al MalkiPrincipal InvestigatorCity of Hope Medical Center
4 Previous Clinical Trials
162 Total Patients Enrolled
1 Trials studying Graft vs Host Disease
50 Patients Enrolled for Graft vs Host Disease

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a Karnofsky performance status of 70 or higher.
Biopsy of acute GvHD target organ is recommended but not required
The evidence of myeloid engraftment is considered sufficient if the ANC is ≥ 0.5 x 10^9/L for 3 consecutive days if ablative therapy was previously used
You have informed consent of the participant and/or legally authorized representative.
The study must be approved by the principal investigator (PI) before the study can be conducted.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.