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

Janssen (J&J Innovative Medicine)

Status: Terminated

Conditions: Chronic Graft vs Host Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT04852692

CR108945

54179060GVH4001 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness of ibrutinib compared to conventional salvage treatments in participants with steroid dependent/refractory chronic graft versus host disease (cGVHD) by measuring overall cGVHD response (modified National Institutes of Health [NIH] response defined complete response [CR] and partial response [PR]) at Week 24.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

15 participants in 2 patient groups

Part A: Retrospective Phase

Description:

Retrospective collection of data for eligible participants with steroid dependent/refractory chronic graft versus host disease (cGVHD) who initiated salvage treatments from initiation point (administration starting point of the salvage treatment) of the identified last-line of conventional salvage therapy for cGVHD treatment as their second-forth line therapy and will be collected for up to 24 weeks from the initiation point.

Part B: Prospective Phase

Description:

Prospectively enroll participants with steroid dependent/refractory cGVHD that are decided to be treated with ibrutinib in second-fourth line therapy for the treatment of cGVHD. Participants will continue to receive corticosteroids as a standard of care.