Phase 2
N=42
Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Chronic Graft Versus Host Disease
Graft Versus Host Disease
Bottom Line
View on ClinicalTrials.gov: NCT02195869 ↗Enrolled (actual)
42
Serious AEs
52.4%
Results posted
Jul 2019
Primary outcome: Primary: Phase 1b: To Evaluate the Safety and Tolerability of Ibrutinib in Steroid Dependent/Refractory cGVHD. — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ibrutinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pharmacyclics LLC.
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase 1b: To Evaluate the Safety and Tolerability of Ibrutinib in Steroid Dependent/Refractory cGVHD. |
— | — |
| PRIMARY Phase 2: Overall Response Rate as the Percentage of Participants With Response |
69 | — |
| SECONDARY Sustained Response Rate as the Percentage of Participants With Sustained Response |
69 | — |
| SECONDARY To Evaluate the Clinical Efficacy of Ibrutinib in Steroid Dependent/Refractory cGVHD by Measuring: Duration of Response (DOR) |
NA | — |
| SECONDARY Corticosteroid Requirement Changes Over Time |
0.31; 0.32; 0.32; 0.31; 0.31; 0.30 | — |
| SECONDARY Percentage of Participants With Overall Improvement in Lee cGVHD Symptom Summary Score |
42.9 | — |
| SECONDARY Phase 2b: To Evaluate the Safety and Tolerability of Ibrutinib in Steroid Dependent/Refractory cGVHD |
42 | — |
Summary
The purpose of this study is to assess the safety and clinical efficacy of ibrutinib in subjects with steroid dependent or refractory Chronic Graft Versus Host Disease.
Eligibility Criteria
Inclusion Criteria
- Steroid dependent or refractory classic chronic GVHD disease.
- 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
- Known or suspected active acute GVHD.
- 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.
Data sourced from ClinicalTrials.gov (NCT02195869). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.