Actively Recruiting
Leflunomide in Combination With Steroids for the Treatment of Acute Graft-versus-Host Disease After Donor Stem Cell Transplant for Hematologic Malignancies
Led by City of Hope Medical Center · Updated on 2025-07-04
18
Participants Needed
1
Research Sites
185 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Leflunomide in Combination With Steroids for the Treatment of Acute Graft-versus-Host Disease After Donor Stem Cell Transplant for Hematologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided documented informed consent and assent when appropriate
- Agreed to allow use of archival tissue from tumor biopsies or obtained approval from study PI
- Age 18 years or older
- Karnofsky performance status of 70 or higher
- Clinically suspected grade II-IV acute graft-versus-host disease after allogeneic stem cell transplant
- Grade I acute graft-versus-host disease requiring systemic steroids is allowed
- Biopsy of affected organ recommended but not required
- Enrollment within 72 hours from start of steroids
- Evidence of myeloid engraftment (ANC \u2265 0.5 x 10^9/L for 3 days if ablative therapy used)
- No prior systemic treatment for acute graft-versus-host disease except up to 72 hours of prednisone \u2264 2 mg/kg/day or equivalent
- Able to swallow and retain oral medication
- Total bilirubin \u2264 2 times upper limit of normal unless Gilbert's disease or recent aGvHD
- AST \u2264 3 times upper limit of normal
- ALT \u2264 3 times upper limit of normal
- Creatinine clearance \u2265 50 mL/min
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective birth control or abstain from heterosexual activity during study and 3 months after
You will not qualify if you...
- Received more than one allogeneic stem cell transplant
- More than 3 days of systemic corticosteroids for acute graft-versus-host disease prior to study
- Presence of graft-versus-host disease overlap syndrome
- Prior treatment with leflunomide
- Current or planned use of other investigational agents or concurrent therapies
- Use of other drugs for acute graft-versus-host disease treatment
- Allergic reactions to leflunomide or cholestyramine
- Clinically significant uncontrolled illness
- On dialysis
- Requires ventilator support
- Active uncontrolled infection causing instability or symptoms
- Known HIV infection
- Active hepatitis B or C requiring treatment or positive viral tests
- Evidence of relapsed primary disease or treated relapse post-transplant
- Severe organ dysfunction unrelated to graft-versus-host disease
- Non-hematologic malignancy within past 3 years except certain treated cancers
- Pregnant or breastfeeding females
- Any other condition that contraindicates participation or compliance issues
AI-Screening
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Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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