TriangleNCT02195869 · CITED IN SOURCE DOCUMENTS
Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Chronic Graft Versus Host Disease
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE1, PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2019-07-11
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Phase 1b: To Evaluate the Safety and Tolerability of Ibrutinib in Steroid Dependent/Refractory cGVHD.
Phase 2: Overall Response Rate as the Percentage of Participants With Response
Sustained Response Rate as the Percentage of Participants With Sustained Response
To Evaluate the Clinical Efficacy of Ibrutinib in Steroid Dependent/Refractory cGVHD by Measuring: Duration of Response (DOR)
Corticosteroid Requirement Changes Over Time
Percentage of Participants With Overall Improvement in Lee cGVHD Symptom Summary Score
Phase 2b: To Evaluate the Safety and Tolerability of Ibrutinib in Steroid Dependent/Refractory cGVHD
Adverse events
Limitations, agreements, and source contact
Who could take part
- 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.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Subjects receive daily dose of 420 mg of Ibrutinib capsules
- intervention Names
- Drug: Ibrutinib
- label
- Phase 1b: Dose Level 1
- type
- EXPERIMENTAL
- description
- Subjects receive daily dose of 280 mg of Ibrutinib capsules
- intervention Names
- Drug: Ibrutinib
- label
- Phase 1b: Dose Level 2
- type
- EXPERIMENTAL
- description
- Subjects receive daily dose of 140 mg of Ibrutinib capsules
- intervention Names
- Drug: Ibrutinib
- label
- Phase 1b: Dose Level 3
- type
- EXPERIMENTAL
- description
- Subjects receive daily dose of recommended phase 2 dose
- intervention Names
- Drug: Ibrutinib
- label
- Phase 2
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Phase 1b: Dose Level 1
- Phase 1b: Dose Level 2
- Phase 1b: Dose Level 3
- Phase 2
- name
- Ibrutinib
- other Names
- PCI32765
- type
- DRUG
Study design
- allocation
- NON_RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 45
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Number of participants with dose-limiting toxicities as a measure of safety profile to determine recommended dose of ibrutinib
- measure
- Phase 1b: To Evaluate the Safety and Tolerability of Ibrutinib in Steroid Dependent/Refractory cGVHD.
- time Frame
- 28 treatment days after last subject enrolled in Phase 1 dose level(s).
- description
- Overall Response Rate is defined as the proportion of subjects who achieved complete response (CR) or partial response (PR). Response criteria are based on NIH cGVHD Response assessment (Pavletic 2006; Measurement of Therapeutic Response, ASBMT Web site).
- measure
- Phase 2: Overall Response Rate as the Percentage of Participants With Response
- time Frame
- Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months.
- secondary Outcomes
- description
- For subjects who achieved an NIH-defined CR or PR, the proportion of subjects who achieved CR or PR that was sustained for at least 20 weeks (140 days). Intermittent SD was also acceptable.
- measure
- Sustained Response Rate as the Percentage of Participants With Sustained Response
- time Frame
- Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months.
- description
- For subjects who achieved an NIH-defined CR or PR, the interval between the date of initial documentation of a response and the date of first documented evidence of PD, death, or date of censoring if applicable.
- measure
- To Evaluate the Clinical Efficacy of Ibrutinib in Steroid Dependent/Refractory cGVHD by Measuring: Duration of Response (DOR)
- time Frame
- Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months.
- description
- Average daily corticosteroid dose assessed each week.
- measure
- Corticosteroid Requirement Changes Over Time
- time Frame
- Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months.
- description
- Subject reported improvement in symptom burden. The symptom burden will be measured according to the Lee cGVHD Symptom Scale. A change in \>7 points on the Lee cGVHD Symptom Scale will be considered significant and relates to improvement in quality of life. A score is calculated for each subscale by taking the mean of all items completed if more than 50% were answered and normalizing to a 0 to 100 scale. A total summary score is calculated as the average of these 7 subscales if at least 4 subscales have valid scores. There are 7 subscales (Skin, Energy, Lung, Eye, Nutrition, Mouth and Psychological) with ratings as follow: 0- Not at all, 1- Slightly, 2 Moderately, 3 Quite a bit, 4-Extremely; with a lower values representing a better outcome.
- measure
- Percentage of Participants With Overall Improvement in Lee cGVHD Symptom Summary Score
- time Frame
- Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months.
- description
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Ibrutinib
- measure
- Phase 2b: To Evaluate the Safety and Tolerability of Ibrutinib in Steroid Dependent/Refractory cGVHD
- time Frame
- From first dose with study drug until 30 days after the last dose of study drug, up to 36.7 months
Full study description
- brief 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.
Source references
- references
- citation
- 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.
- pmid
- 34102349
- type
- DERIVED
- citation
- 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.
- pmid
- 31260802
- type
- DERIVED
- citation
- 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.
- pmid
- 28924018
- type
- DERIVED
Source notices and limitations
Discovery and provenance
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- ossed over to receive IMBRUVICA. 14. 3 Chronic Graft versus Host Disease Study 1129 The safety and efficacy of IMBRUVICA in cGVHD were evaluated in Study 1129 (NCT02195869), an open-label, multi-center, single-arm trial of 42 patients with cGVHD after failure of first line corticosteroid therapy and requiring additional therapy.
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Preserved source evidence · Not medical advice