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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)

Must not have

Recipient of more than one allogeneic HCT

Current or planned use of other investigational agents, or concurrent biological, chemotherapy, or radiation therapy during the study treatment period

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

No Placebo-Only Group

Approved for 5 Other Conditions

All Individual Drugs Already Approved

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received more than one bone marrow transplant from a donor.

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I am not using, nor do I plan to use, other experimental treatments or therapies during this study.

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I do not have severe organ problems not caused by GvHD.

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I need a machine to help me breathe or a lot of extra oxygen.

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I do not have ongoing liver problems due to bile flow issues or unresolved veno-occlusive disease.

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I do not have severe heart problems that are not under control.

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I am currently receiving dialysis.

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I have been treated with steroids for more than 3 days for graft-versus-host disease.

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I am not pregnant or breastfeeding.

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I have been diagnosed with GVHD overlap syndrome.

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I have been diagnosed with HIV.

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I have been treated with leflunomide before.

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I do not have an active infection causing severe symptoms or instability.

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My prostate cancer is low grade and my PSA levels are stable.

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I have early-stage cervical cancer.

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I am taking medication for acute graft-versus-host disease.

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I have been treated for skin cancer.

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I have been successfully treated for a non-invasive breast cancer.

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My cancer returned after a stem cell transplant from a donor.

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I have a serious illness that is not under control.

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I need a machine to help me breathe.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events

Secondary study objectives

Failure-free survival (FFS)

Incidence of bloodstream infection severity

Sepsis

+4 more

Awards & Highlights

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.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Leflunomide

FDA approved

Cholestyramine

FDA approved

0 / 26Eligibility criteria met