Front Line Ibrutinib for Newly Diagnosed Chronic Graft-Versus Host Disease

  • STATUS
    Recruiting
  • End date
    Jun 28, 2024
  • participants needed
    40
  • sponsor
    National Cancer Institute (NCI)
Updated on 18 June 2022
bone marrow transplant
immunosuppressive agents
budesonide
neutrophil count
immunosuppression
acute graft-versus-host disease
urine test
beclomethasone
ibrutinib

Summary

Background

Chronic Graft Versus Host Disease (cGVHD) can occur after a person has had a stem cell or bone marrow transplant. In cGVHD, the donor cells attack the recipient s body. Researchers want to see if a drug called ibruntinib can block one of the proteins that lead to the immune reaction that causes cGVHD.

Objective

To see if ibrutinib as a first-line treatment can help people with newly diagnosed cGVHD.

Eligibility

People age 18 and older with newly diagnosed moderate or severe cGVHD

Design

Participants will be screened with

medical and medicine histories

physical exam and vital signs

electrocardiograms (to measure heart function)

assessment of their ability to perform daily activities

blood and urine tests

assessment of their general well-being.

Participants will visit the Clinical Center every 2 weeks for the first 2 months. Then they will visit every 4 weeks.

Participants will take ibrutinib by mouth once every day of every cycle. One cycle is 28 days. Treatment will last up to 2 years. Participants will keep a medicine diary.

Participants will take tests to measure lung function. They may have computed tomography scans of their chest. They will complete questionnaires about their symptoms and how cGVHD is affecting their body and quality of life. They will repeat the screening tests.

Participants may have optional blood tests and/or skin biopsies to better understand the drug s effect on the body.

Participants will be contacted by phone 30 days after treatment ends. They will also be contacted once a year for 2 years to discuss how they are feeling and if they have taken any other medicines to treat cGVHD.

Description

Background
  • Chronic graft-versus-host disease (GvHD) is the leading cause of late morbidity and non-relapse mortality following allogeneic hematopoietic stem cell transplantation (alloHSCT), occurring in 40-60% long-term survivors.
  • Chronic GvHD occurs due to the dysfunctional peripheral tolerance during post-transplant hematopoietic reconstitution that allows the development and persistence of alloreactive donor-derived T and B cells.
  • Prednisone is the front-line therapy; however, about 50% of participants have steroid-refractory disease and there is no standard second-line therapy.
  • The most attractive approach for controlling chronic GvHD would be early therapy intervention which could prevent the most severe and irreversible clinical manifestations.
  • Anti-B-cell therapy delivered early in chronic GvHD could be effective and steroid-sparing.
  • Ibrutinib, reversible small molecule inhibitor of Bruton s tyrosine kinase, has been shown to be well-tolerated and effective in phase 1b/2 trial for steroid refractory chronic GvHD.
    Objective

-To evaluate efficacy of ibrutinib as a first-line treatment for persons with newly diagnosed chronic GvHD by measuring the overall response rate (complete response [CR] + partial response [PR]) at 6 months, according to the 2014 NIH Consensus Criteria

Eligibility
  • Newly diagnosed, moderate or severe chronic GvHD according to the 2014 NIH Consensus Criteria, requiring systemic immunosuppression
  • Age greater than or equal to 18 years old
  • Karnofsky performance status greater than or equal to 60%
  • History of prior alloHSCT; any donors, conditioning regimens and graft sources are allowed
  • Adequate cardiac, hepatic and other organ function
  • Adequate laboratory parameters
Design
  • Multi-center, non-randomized, phase II study
  • Two-stage design will be used to determine the overall response rate (CR + PR) at 6 months
  • Continuous daily dose of ibrutinib 420 mg by mouth, with the potential for dose reductions to 280 mg and 140 mg
  • The accrual ceiling will be set at 40 participants, allowing for a total of up to 28 evaluable subjects.

Details
Condition Chronic GVHD
Treatment Ibrutinib
Clinical Study IdentifierNCT04294641
SponsorNational Cancer Institute (NCI)
Last Modified on18 June 2022

Eligibility

How to participate?

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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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