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Ibrutinib for Preventing Graft-versus-Host Disease

Phase 2

Recruiting

Led By Mohamed A. Kharfan Dabaja, MD, MBA

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

HLA matched-related, matched unrelated donors (defined as 8/8 [class I: HLA A, B, C, and class II: DRB1]), or HLA-mismatched-unrelated donors (defined as 7/8 [with single mismatch at class I: HLA A, B, C, or class II: DRB1])

Absolute neutrophil count (ANC) must be ≥ 1000/mm^3 (without growth factor support) (obtained ≤ 7 days prior to registration)

Must not have

Uncontrolled acute GVHD at time of registration

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 year post registration

Awards & highlights

No Placebo-Only Group

Summary

This trial evaluates how effective ibrutinib is in preventing chronic graft-versus-host disease (GVHD) in patients receiving donor hematopoietic cell transplantation. In this treatment, patients receive

Who is the study for?

This trial is for patients who've had a donor stem cell transplant to treat conditions like cancer. It's designed to see if taking Ibrutinib after the transplant can prevent chronic graft-versus-host disease, which happens when donor cells attack the patient's body.

What is being tested?

The study is testing Ibrutinib, a kinase inhibitor that blocks proteins involved in immune responses that could lead to chronic GVHD. The goal is to determine if it can help prevent this condition post-transplant.

What are the potential side effects?

Ibrutinib may cause side effects such as diarrhea, bleeding problems, high blood pressure, infections due to low white blood cell counts, irregular heartbeat, and muscle and bone pain.

Eligibility Criteria

Inclusion Criteria

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

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My donor is a perfect or near-perfect match for my bone marrow transplant.

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My white blood cell count is healthy without medication.

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I am 18 years old or older.

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I am mostly able to care for myself.

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My kidney function, measured by creatinine clearance, is good.

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I agree to use effective birth control and a barrier method during and for 3 months after treatment.

Exclusion Criteria

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

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I currently have uncontrolled acute graft-versus-host disease.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I am not on chemotherapy, immunotherapy, experimental drugs, or radiotherapy while taking ibrutinib.

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I do not have any untreated serious infections.

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I cannot swallow pills or have a stomach condition that affects drug absorption.

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I have not had a heart attack or uncontrolled heart rhythm problems in the last 6 months.

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I have chronic GVHD as confirmed by NIH before or at registration.

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My condition worsened after my last transplant.

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My cancer has spread to my brain or spinal cord.

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I need blood thinners like warfarin.

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My liver disease is moderate to severe.

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I have not had any other cancer in the last 5 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 year post registration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 1 year post registration

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 year post registration for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Cumulative incidence of NIH moderate/severe chronic graft-versus-host disease (GVHD)

Secondary study objectives

Cumulative incidence of chronic GVHD of all grades

Cumulative incidence of complete immune suppression (IS) discontinuation

Cumulative incidence of late acute GVHD

+7 more

Awards & Highlights

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: Prevention (ibrutinib)Experimental Treatment3 Interventions

Patients receive ibrutinib PO QD on days 1-30 of each cycle. Cycles repeat every 30 days for up to 12 cycles on study. Additionally, patients undergo an echocardiography prior to registration and blood sample collection throughout study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Echocardiography

2013

Completed Phase 4

~11580

Biospecimen Collection

2004

Completed Phase 3

~2030