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Prevention (ibrutinib) for Graft-versus-Host Disease

Q: Has the FDA given its approval for Ibrutinib to be used in preventing a specific condition?

<p>Power's team rates the safety of Prevention (<a href="https://www.withpower.com/clinical-trials/ibrutinib">ibrutinib</a>) as a 2 on the scale, indicating that in this Phase 2 trial there is some evidence supporting its safety but no data yet confirming its effectiveness.</p>

Phase 2

Waitlist Available

Led By Mohamed A. Kharfan Dabaja, M.D., M.B.A.

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 year post registration

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Cumulative incidence of chronic GVHD of all grades

Cumulative incidence of complete immune suppression (IS) discontinuation

Cumulative incidence of late acute GVHD

+7 more

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 and echocardiography prior to registration and blood sample collection throughout study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ibrutinib

2014

Completed Phase 4

~1890

Biospecimen Collection

2004

Completed Phase 2

~1700

Echocardiography

2013

Completed Phase 4

~11670

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,220 Previous Clinical Trials

3,767,911 Total Patients Enrolled

Mohamed A. Kharfan Dabaja, M.D., M.B.A.Principal InvestigatorMayo Clinic

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available for patients to participate in this trial?

"As per the data provided on clinicaltrials.gov, recruitment for this particular research endeavor has concluded. The listing was initially made public on March 1st, 2024 and last amended on February 14th of the same year. Although recruitment is closed for this trial, there are currently an additional 167 trials actively seeking participants at present."

Answered by AI

Has the FDA given its approval for Ibrutinib to be used in preventing a specific condition?

"Power's team rates the safety of Prevention (ibrutinib) as a 2 on the scale, indicating that in this Phase 2 trial there is some evidence supporting its safety but no data yet confirming its effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ibrutinib for the Prevention of Chronic Graft-Versus-Host Disease in Patients Undergoing Donor Stem Cell Transplant

2024. "Ibrutinib for the Prevention of Chronic Graft-Versus-Host Disease in Patients Undergoing Donor Stem Cell Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06271616.

All > Graft Vs Host Disease