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Prevention (ibrutinib) for Graft-versus-Host Disease

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 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 an 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
~1720
Echocardiography
2013
Completed Phase 4
~11670

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,239 Previous Clinical Trials
3,771,559 Total Patients Enrolled
Mohamed A. Kharfan Dabaja, M.D., M.B.A.Principal InvestigatorMayo Clinic
~27 spots leftby Jun 2027
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