10 Participants Needed

Ibrutinib for Chronic Graft-versus-Host Disease

Recruiting at 2 trial locations
SZ
Overseen BySteven Z Pavletic, M.D.
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: National Cancer Institute (NCI)
Must be taking: Immunosuppressive medications
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing ibrutinib, a pill that blocks a protein causing harmful immune reactions, in adults with newly diagnosed moderate or severe chronic graft-versus-host disease (cGVHD). The goal is to see if this drug can help control the disease by reducing the immune system's attack on the body. Ibrutinib was the first agent approved by the U.S. Food and Drug Administration for the treatment of chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy.

Do I need to stop my current medications to join the trial?

The trial does not require you to stop your current medications, but your doses of other immunosuppressive drugs should be stable for at least 2 weeks before starting the study. You should discuss your specific medications with the trial team to ensure they are compatible with the study requirements.

Is ibrutinib safe for treating chronic graft-versus-host disease?

Ibrutinib, also known as Imbruvica, is generally considered safe for treating chronic graft-versus-host disease, but it can have side effects. Common side effects include muscle pain, fever, pneumonia, stomach pain, mouth sores, diarrhea, and headaches. There are also warnings about more serious risks like bleeding, infections, heart problems, and high blood pressure.12345

How is the drug ibrutinib unique in treating chronic graft-versus-host disease?

Ibrutinib is unique because it is the first drug approved for treating chronic graft-versus-host disease (cGVHD) in both adults and children after other treatments have failed. It works by inhibiting Bruton's tyrosine kinase (BTK), which is different from the standard first-line treatment of high-dose corticosteroids.13467

What data supports the effectiveness of the drug ibrutinib for chronic graft-versus-host disease?

Ibrutinib has been shown to help patients with chronic graft-versus-host disease (cGVHD) who did not respond to other treatments, with studies showing it can improve symptoms and survival. It works by targeting specific cells involved in cGVHD, and has been approved by the FDA for this use based on clinical trial results.13468

Who Is on the Research Team?

SZ

Steven Z Pavletic, M.D.

Principal Investigator

National Cancer Institute (NCI)

Are You a Good Fit for This Trial?

Adults over 18 with newly diagnosed moderate or severe chronic Graft-versus-Host Disease after a stem cell or bone marrow transplant can join. They must be responding to current treatments, agree to use birth control, and have no uncontrolled infections, bleeding disorders, other cancers (with some exceptions), heart issues, hepatitis B/C, or known allergy to Ibrutinib.

Inclusion Criteria

I have had a stem cell transplant from a donor.
I have been newly diagnosed with moderate or severe chronic GvHD and need systemic immunosuppression.
Your test results must be within certain ranges.
See 5 more

Exclusion Criteria

I do not have any uncontrolled infections or bleeding disorders.
My cancer has returned or worsened.
The researchers can decide not to include you for other reasons and they will write it down in your medical record.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive ibrutinib daily for up to 2 years, with regular monitoring and assessments

24 months
Every 2 weeks for the first 2 months, then every 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with annual check-ins for 2 years

24 months
Annual contact

What Are the Treatments Tested in This Trial?

Interventions

  • Ibrutinib
Trial Overview The trial is testing if Ibrutinib can help as a first-line treatment for cGVHD without needing steroids. Participants will take the drug daily for up to two years and attend regular check-ups including physical exams and lung function tests while keeping a medicine diary.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Ibrutinib Without CorticosteroidsExperimental Treatment16 Interventions

Ibrutinib is already approved in European Union, United States, Canada, Japan for the following indications:

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Approved in European Union as Imbruvica for:
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Approved in United States as Imbruvica for:
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Approved in Canada as Imbruvica for:
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Approved in Japan as Imbruvica for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

Ibrutinib (IMBRUVICA) was approved by the FDA for treating chronic graft versus host disease (cGVHD) after other treatments failed, based on a trial with 42 patients that included patient-reported outcomes (PRO) to support efficacy results.
In the trial, 18 patients showed a significant improvement in symptoms, with 10 maintaining this improvement over time, indicating that ibrutinib not only helps clinicians assess treatment effectiveness but also aligns with patients' experiences of symptom relief.
FDA review summary of patient-reported outcome results for ibrutinib in the treatment of chronic graft versus host disease.King-Kallimanis, BL., Wroblewski, T., Kwitkowski, V., et al.[2021]
In the phase III iNTEGRATE study involving 193 patients with chronic graft-versus-host disease (cGVHD), the combination of ibrutinib and prednisone did not show a statistically significant improvement in response rates compared to placebo plus prednisone after 48 weeks.
Both treatment groups experienced similar rates of serious adverse events (49% for ibrutinib-prednisone and 47% for placebo-prednisone), indicating that ibrutinib did not introduce new safety concerns in previously untreated cGVHD patients.
Ibrutinib for First-Line Treatment of Chronic Graft-Versus-Host Disease: Results From the Randomized Phase III iNTEGRATE Study.Miklos, DB., Abu Zaid, M., Cooney, JP., et al.[2023]
Ibrutinib, an FDA-approved drug, shows promise in reversing established chronic graft-versus-host disease (cGVHD) in mouse models by improving survival and reducing disease symptoms, indicating its potential efficacy as a treatment.
The study highlights that both CD4+ T cells and B cells are crucial in the development of cGVHD, and ibrutinib's ability to inhibit these cells suggests it could be a valuable therapeutic option for patients with cGVHD.
Ibrutinib treatment ameliorates murine chronic graft-versus-host disease.Dubovsky, JA., Flynn, R., Du, J., et al.[2021]

Citations

FDA review summary of patient-reported outcome results for ibrutinib in the treatment of chronic graft versus host disease. [2021]
Ibrutinib for First-Line Treatment of Chronic Graft-Versus-Host Disease: Results From the Randomized Phase III iNTEGRATE Study. [2023]
Ibrutinib treatment ameliorates murine chronic graft-versus-host disease. [2021]
Ibrutinib for the treatment of patients with chronic graft-versus-host disease after failure of one or more lines of systemic therapy. [2021]
Ibrutinib: Pediatric First Approval. [2023]
Drug Receives New Indication for Pediatric Graft-Versus-Host Disease. [2023]
Ibrutinib Treatment of Pediatric Chronic Graft-versus-Host Disease: Primary Results from the Phase 1/2 iMAGINE Study. [2022]
An Open-Label, Single-Arm, Multicenter Study of Ibrutinib in Japanese Patients With Steroid-dependent/Refractory Chronic Graft-Versus-Host Disease. [2021]
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