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Immunomodulatory Agent

Leflunomide for Chronic Graft Versus Host Disease

Phase 1

Waitlist Available

Led By Amandeep Salhotra

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

Able to swallow pills

Participants must have steroid-dependent cGVHD. Steroid dependent cGVHD is defined as having persistent signs and symptoms of cGVHD despite the use of prednisone for 2 months without complete resolution of signs and symptoms. Both classic cGVHD and overlap syndromes will be allowed to participate

Must not have

Patients requiring ventilator support

Patients on dialysis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 48 weeks

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trial is studying leflunomide to see if it can help patients with cGVHD who have not responded to steroids.

Who is the study for?

This trial is for patients with chronic graft versus host disease (cGVHD) after a bone marrow transplant, who are dependent on steroids without full relief of symptoms. Participants must have stable organ function and blood counts, be able to swallow pills, and not be pregnant or breastfeeding. They should agree to use birth control and have no active infections or other serious health issues that could interfere with the study.

What is being tested?

The trial is testing Leflunomide's effectiveness in treating cGVHD symptoms when steroids alone aren't enough. It aims to see if this drug can reduce the immune response causing inflammation without the complications linked to prolonged steroid use.

What are the potential side effects?

Leflunomide may cause side effects such as diarrhea, liver enzyme changes, blood pressure variations, potential harm to an unborn child (hence contraception requirement), and possibly others related to weakening of the immune system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can swallow pills.

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I have chronic GVHD that hasn't improved with 2 months of prednisone treatment.

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I have received a stem cell transplant from another person.

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My white blood cell count is healthy without needing medication in the past week.

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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 need a machine to help me breathe.

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I am currently receiving dialysis.

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I am currently experiencing diarrhea not caused by cGVHD.

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I do not have any uncontrolled serious illnesses.

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I do not have any uncontrolled illnesses or active infections.

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My cancer has returned and is active.

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I do not have any active cancer except for minor skin cancer.

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I am experiencing acute graft-versus-host disease.

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I do not have severe heart problems like uncontrolled chest pain or heart failure.

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I am not pregnant and not nursing.

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I have a history of HIV or hepatitis B/C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 48 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 48 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Dose limiting toxicity

Secondary study objectives

Changes in cGVHD severity

Changes in steroid doses while on therapy

Changes in symptom activity

+4 more

Other study objectives

Effect of leflunomide consumption of the presence and levels of GVHD inflammatory biomarkers

Presence and levels of immune cells (i.e., T and B cells, regulatory T cells [T regs], T cell receptor excision circles [TRECs]) after leflunomide consumption

Side effects data

From 2015 Phase 4 trial • 400 Patients • NCT01172639

33%

Upper respiratory tract infection

26%

Abdominal pain

23%

Nausea

19%

Gastroenteritis

16%

Hairloss

14%

Liver function disturbance

12%

Tendinopathy

12%

Arthralgia

Eczema

Vertigo

Hypertension

Arthrosis

Increased transpiration

Back pain

Agitation

Tooth extraction

Paresthesia

Pruritus

Sjogren's disease

Venous insufficiency

Palpitations

Anaemia

Influenza infection

Fatigue

Muscle cramps

Headache

Bronchitis

General malaise

Arthritis

Flushes

Pyrosis

Endometrioid adenocarcinoma

Intervertebral disc disorder

Rotator cuff lesion

Bladder infection

Eye infection

Insomnia

Diarrhoea

Angina

Kidney cancer malignant

Pneumonia

Cough

Genital infection

100%

80%

60%

40%

20%

Study treatment Arm

CoBRA Slim Low Risk Group

Tight Step Up Low Risk Group

CoBRA Classic High Risk Group

CoBRA Slim High Risk Group

CoBRA Avant-garde High Risk Group

Awards & Highlights

All Individual Drugs Already Approved

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

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

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 (leflunomide)Experimental Treatment1 Intervention

Patients receive leflunomide PO QD for days 1-28. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients may optionally continue leflunomide for an additional 6 cycles as long as response or stable disease is maintained.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Leflunomide

FDA approved

0 / 16Eligibility criteria met