Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Chronic Graft Versus Host Disease
NCT ID: NCT02195869
Last Updated: 2019-07-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
45 participants
INTERVENTIONAL
2014-07-14
2017-09-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Phase 1b: Dose Level 1
Subjects receive daily dose of 420 mg of Ibrutinib capsules
Ibrutinib
Phase 1b: Dose Level 2
Subjects receive daily dose of 280 mg of Ibrutinib capsules
Ibrutinib
Phase 1b: Dose Level 3
Subjects receive daily dose of 140 mg of Ibrutinib capsules
Ibrutinib
Phase 2
Subjects receive daily dose of recommended phase 2 dose
Ibrutinib
Interventions
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Ibrutinib
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No more than 3 previous treatments for cGVHD.
* Receiving baseline systemic glucocorticoid therapy (at stable dose) for cGVHD at study entry.
* Men and women ≥18 years old.
* Karnofsky performance status ≥60.
Exclusion Criteria
* Current treatment with sirolimus AND either cyclosporine or tacrolimus.
* History of treatment with a tyrosine kinase inhibitor (eg, imatinib), purine analogs or other cancer chemotherapy in the 4 weeks prior to starting study drug.
* Currently active, clinically significant cardiovascular disease.
* Uncontrolled infections not responsive to antibiotics, antiviral medicines, or antifungal medicines or a recent infection requiring systemic treatment that was completed ≤14 days before the first dose of study drug.
* Progressive underlying malignant disease including post-transplant lymphoproliferative disease.
* History of other malignancy (not including the underlying malignancy that was the indication for transplant)
* Concomitant use of warfarin or other Vitamin K antagonists
* Known bleeding disorders or hemophilia.
* History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
* Known history of human immunodeficiency virus (HIV) or active with hepatitis C virus (HCV) or hepatitis B virus (HBV).
* Concurrent use of a strong cytochrome P450(CYP) 3A inhibitor.
18 Years
ALL
No
Sponsors
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Pharmacyclics LLC.
INDUSTRY
Responsible Party
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Principal Investigators
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Lori Styles, MD
Role: STUDY_DIRECTOR
Pharmacyclics LLC.
Locations
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City of Hope Medical Center
Duarte, California, United States
University of California, San Francisco
San Francisco, California, United States
Stanford University
Stanford, California, United States
Emory University, Winship Cancer Institute
Atlanta, Georgia, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Vanderbilt University Medical Center, Henry-Joyce Cancer Clinic
Nashville, Tennessee, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Countries
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References
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Doki N, Toyosaki M, Shiratori S, Osumi T, Okada M, Kawakita T, Sawa M, Ishikawa T, Ueda Y, Yoshinari N, Nakahara S. An Open-Label, Single-Arm, Multicenter Study of Ibrutinib in Japanese Patients With Steroid-dependent/Refractory Chronic Graft-Versus-Host Disease. Transplant Cell Ther. 2021 Oct;27(10):867.e1-867.e9. doi: 10.1016/j.jtct.2021.05.019. Epub 2021 Jun 6.
Waller EK, Miklos D, Cutler C, Arora M, Jagasia MH, Pusic I, Flowers MED, Logan AC, Nakamura R, Chang S, Clow F, Lal ID, Styles L, Jaglowski S. Ibrutinib for Chronic Graft-versus-Host Disease After Failure of Prior Therapy: 1-Year Update of a Phase 1b/2 Study. Biol Blood Marrow Transplant. 2019 Oct;25(10):2002-2007. doi: 10.1016/j.bbmt.2019.06.023. Epub 2019 Jun 28.
Miklos D, Cutler CS, Arora M, Waller EK, Jagasia M, Pusic I, Flowers ME, Logan AC, Nakamura R, Blazar BR, Li Y, Chang S, Lal I, Dubovsky J, James DF, Styles L, Jaglowski S. Ibrutinib for chronic graft-versus-host disease after failure of prior therapy. Blood. 2017 Nov 23;130(21):2243-2250. doi: 10.1182/blood-2017-07-793786. Epub 2017 Sep 18.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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PCYC-1129-CA
Identifier Type: -
Identifier Source: org_study_id
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