A Study to Investigate the Comparative Effectiveness of Ibrutinib in Steroid Dependent/Refractory cGVHD Participants

Primary outcomes

• Part A and Part B: Percentage of Participants with Overall Response Rate [Week 24]: Overall response rate is defined as the percentage of participants who achieve complete response (CR) or partial response (PR) according to modified National Institutes of Health (NIH) response.

Secondary outcomes

• Part B: Rate of Sustained Response [At least 5 months (up to 36 weeks)]: Sustained response rate will be assessed.
• Part B: Duration of Response [Up to 5 months]: Duration of response will be assessed.
• Part A and Part B: Corticosteroid Requirement Changes Over Time [Up to 24 weeks]: The change of the corticosteroid dose requirement during the treatment will be assessed.
• Part B: Time to cGVHD Progression [Up to 36 weeks]: Time to chronic graft versus host disease (cGVHD) progression is defined as the time from the first dose of the ibrutinib to modified NIH response defined progression.
• Part B: Change in Lee cGVHD Symptom Scale [Up to 36 weeks]: Change in Lee cGVHD symptom scale will be assessed. It is a participant reported improvement in symptom burden.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

Part A and Part B

* Must have a confirmed diagnosis of steroid dependent or refractory classic cGVHD defined at any time post-hematopoietic cell transplantation (HCT) as: a) refractory disease - progressive cGVHD manifestations requiring prednisolone at greater than or equal to (>=) 1 milligram per kilogram per day (mg/kg/day) for at least 1 week or persist without improvement despite continued treatment with glucocorticoid (prednisolone at >= 0.5 mg/kg/day or 1 mg/kg every other day) for at least 4 weeks; b) dependent disease: persistent cGVHD manifestations requiring glucocorticoid >= prednisolone 0.25 mg/kg/day or >=0.5mg/kg every other day for at least 8 weeks Part A
* Treated at least 2 or more therapies for cGVHD (including glucocorticoids)
* Participants whose identified last line of conventional salvage treatment is second-fourth line of therapy
* Index date (initiation date of the identified last-line of conventional salvage therapy) at least 28 weeks before the study initiation date Part B
* Treated at least 3 lines therapies for cGVHD (including glucocorticoids)
* Participants who are treated with ibrutinib in their second-fourth line of therapy

Exclusion Criteria:

Part A and Part B

* Known or suspected active acute GVHD
* Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 28 days Part A
* Treated with an investigational agent for their identified last-line of conventional salvage therapy
* Pregnant, breastfeeding during last-line of conventional salvage therapy Part B
* Pregnant, breast-feeding, or of childbearing potential without a negative serum or urine pregnancy test within 7 days of enrollment. Male or female participants of childbearing potential unwilling to use effective contraceptive precautions throughout the trial

• Janssen Korea, Ltd., Korea Clinical Trial, Study director, Janssen Korea, Ltd., Korea