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

Chronic Graft vs Host Disease Clinical Trial

Official title:

A Retrospective/Prospective, Multicenter, Non-interventional, Historical Control Study Investigating Comparative Effectiveness of IMBRUVICA in Steroid Dependent/Refractory cGVHD Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04852692
• Other study ID #: CR108945
• Secondary ID: 54179060GVH4001
• Status: Terminated
• Start date: June 21, 2021
• Est. completion date: August 6, 2021

Study information

• Verified date: March 2024
• Source: Janssen Korea, Ltd., Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: August 6, 2021
• Est. primary completion date: August 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Graft vs Host Disease
• Graft vs Host Disease

Locations

Country	Name	City	State
Korea, Republic of	Soonchunhyang University Bucheon Hospital	Bucheon-Si
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	Soonchunhyang University Seoul Hospital	Seoul
Korea, Republic of	The Catholic University of Korea Seoul St. Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Korea, Ltd., Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A and Part B: Percentage of Participants with Overall Response Rate	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.	Week 24
Secondary	Part B: Rate of Sustained Response	Sustained response rate will be assessed.	At least 5 months (up to 36 weeks)
Secondary	Part B: Duration of Response	Duration of response will be assessed.	Up to 5 months
Secondary	Part A and Part B: Corticosteroid Requirement Changes Over Time	The change of the corticosteroid dose requirement during the treatment will be assessed.	Up to 24 weeks
Secondary	Part B: Time to cGVHD Progression	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.	Up to 36 weeks
Secondary	Part B: Change in Lee cGVHD Symptom Scale	Change in Lee cGVHD symptom scale will be assessed. It is a participant reported improvement in symptom burden.	Up to 36 weeks