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Immunosuppressant
Leflunomide + Steroids for Graft-versus-Host Disease
Phase 1
Recruiting
Led By Monzr M Al Malki
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >= 18 years old
Creatinine clearance of >= 50 mL/min per 24-hour urine test or the Cockcroft-Gault formula (performed within 14 days prior to day 1 of protocol therapy)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
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.
Who is the study for?
Adults (18+) who've had a stem cell transplant for blood cancer and are now facing acute graft-versus-host disease can join. They must be able to take oral meds, have no severe organ issues unrelated to the disease, not be on dialysis or have uncontrolled infections, and agree to birth control if applicable. Prior leflunomide use or more than 72 hours of steroids for this condition disqualifies them.Check my eligibility
What is being tested?
The trial is testing the safety of combining leflunomide with steroids in treating acute graft-versus-host disease post-stem cell transplant. It's seeing if this combo helps manage immune responses better so that donor cells don't attack the patient's body.See study design
What are the potential side effects?
Leflunomide may cause liver problems, high blood pressure, nausea, diarrhea, hair loss, rash or itchy skin. Steroids can lead to mood swings, weight gain, sleep issues and higher infection risk. Cholestyramine might cause digestive discomfort like constipation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My kidney function, measured by creatinine clearance, is adequate.
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I can swallow and keep down pills.
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I am a woman who can have children and my pregnancy test is negative.
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I am able to care for myself but may not be able to do active work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
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
Sepsis
+5 moreTrial 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cholestyramine
FDA approved
Leflunomide
FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,836 Total Patients Enrolled
1 Trials studying Graft-versus-Host Disease
236 Patients Enrolled for Graft-versus-Host Disease
City of Hope Medical CenterLead Sponsor
567 Previous Clinical Trials
1,922,642 Total Patients Enrolled
Monzr M Al MalkiPrincipal InvestigatorCity of Hope Medical Center
6 Previous Clinical Trials
316 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am capable of having children and have not been surgically sterilized.I have received more than one bone marrow transplant from a donor.I haven't had cancer other than my current one in the last 3 years.I do not have severe organ problems not caused by GvHD.I need a machine to help me breathe or a lot of extra oxygen.I do not have ongoing liver problems due to bile flow issues or unresolved veno-occlusive disease.I do not have severe heart problems that are not under control.I have only used prednisone for acute GvHD for less than 72 hours.I am currently receiving dialysis.I am 18 years old or older.I started steroids for GvHD less than 72 hours ago and haven't delayed joining because of biopsy results.I have been treated with steroids for more than 3 days for graft-versus-host disease.I am not using, nor do I plan to use, other experimental treatments or therapies during this study.I do not have active hepatitis needing treatment, or if I had it, it's now undetectable.My kidney function, measured by creatinine clearance, is adequate.I am not pregnant or breastfeeding.I have been diagnosed with GVHD overlap syndrome.I have been diagnosed with HIV.I have been treated with leflunomide before.I do not have an active infection causing severe symptoms or instability.My white blood cell count is healthy after treatment.My prostate cancer is low grade and my PSA levels are stable.I am suspected to have a moderate to severe reaction after a bone marrow transplant.I have received a stem cell transplant for blood cancer or disorder, regardless of the donor or source.I have early-stage cervical cancer.I am taking medication for acute graft-versus-host disease.I have been treated for skin cancer.I have been successfully treated for a non-invasive breast cancer.I can swallow and keep down pills.I am a woman who can have children and my pregnancy test is negative.You have had allergic reactions in the past to medicines that are similar to the study drug (leflunomide or cholestyramine).My cancer returned after a stem cell transplant from a donor.I have a serious illness that is not under control.I need a machine to help me breathe.I am able to care for myself but may not be able to do active work.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment of aGVHD (steroid therapy, leflunomide)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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 clinicaltrials.gov, 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
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