Chronic Graft vs Host DiseaseNCT04852692
A Study to Investigate the Comparative Effectiveness of Ibrutinib in Steroid Dependent/Refractory cGVHD Participants
An observational study of Chronic Graft vs Host Disease, run by Janssen Korea, Ltd., Korea at 8 sites in South Korea.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Graft vs Host Disease
- How many people
- 15 participants
- Where
- 8 sitesSouth Korea
- Study dates
- 21 Jun 2021to 6 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with steroid dependent or refractory chronic graft versus host disease (cGVHD) will be included.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
8 sites in 1 country.
8 sites in 1 country
South Korea8 sites
Soonchunhyang University Bucheon Hospital
Bucheon-si, 14584
Pusan National University Hospital
Busan, 49241
Kyungpook National University Hospital
Daegu, 41944
Seoul National University Hospital
Seoul, 03080
Severance Hospital
Seoul, 03722
Soonchunhyang University Seoul Hospital
Seoul, 04401
Samsung Medical Center
Seoul, 06351
The Catholic University of Korea Seoul St Mary s Hospital
Seoul, 06591
About this study
Official title: A Retrospective/Prospective, Multicenter, Non-interventional, Historical Control Study Investigating Comparative Effectiveness of IMBRUVICA in Steroid Dependent/Refractory cGVHD Patients
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.
- Conditions
- Chronic Graft vs Host Disease
- Keywords
- Chronic, Ibrutinib, Retrospective, Prospective
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Part A: Retrospective Phase | 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 | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 24
Secondary outcomes (5)
Part B: Rate of Sustained Response
Sustained response rate will be assessed.
Measured: At least 5 months (up to 36 weeks)
Part B: Duration of Response
Duration of response will be assessed.
Measured: Up to 5 months
Part A and Part B: Corticosteroid Requirement Changes Over Time
The change of the corticosteroid dose requirement during the treatment will be assessed.
Measured: Up to 24 weeks
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.
Measured: Up to 36 weeks
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.
Measured: Up to 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start21 Jun 2021
- Primary completion6 Aug 2021
- Study completion6 Aug 2021
Why it stopped: After conducting pilot phase, the study team decided to stop the study as the study couldn't meet the study target number of patients and study objectives.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Graft vs Host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Korea, Ltd., Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Korea, Ltd., Korea Clinical Trial, Study director, Janssen Korea, Ltd., Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852692
- Sponsor's protocol ID
- CR108945
- Other IDs
- 54179060GVH4001
- Status last verified
- May 2025
- First submitted
- 16 Apr 2021
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective/Prospective, Multicenter, Non-interventional, Historical Control Study Investigating Comparative Effectiveness of IMBRUVICA in Steroid Dependent/Refractory cGVHD Patients
- ClinicalTrials.gov ID
- NCT04852692
- Acronym / sponsor ID
- CR108945
- Conditions
- Chronic Graft vs Host Disease
- Keywords
- Chronic, Ibrutinib, Retrospective, Prospective
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: After conducting pilot phase, the study team decided to stop the study as the study couldn't meet the study target number of patients and study objectives.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Janssen Korea, Ltd., KoreaIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 6 Aug 2021 (actual)
- Study completion
- 6 Aug 2021 (actual)
- First posted
- 21 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: Retrospective Phase | – | –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 | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with steroid dependent or refractory chronic graft versus host disease (cGVHD) will be included.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Part A and Part B: Percentage of Participants with Overall Response Rate
Time frame: 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.
5 secondary outcomes
Part B: Rate of Sustained Response
Time frame: At least 5 months (up to 36 weeks)
Part B: Duration of Response
Time frame: Up to 5 months
Part A and Part B: Corticosteroid Requirement Changes Over Time
Time frame: Up to 24 weeks
Part B: Time to cGVHD Progression
Time frame: Up to 36 weeks
Part B: Change in Lee cGVHD Symptom Scale
Time frame: Up to 36 weeks
Results and safety
The study was stopped early (reason given: After conducting pilot phase, the study team decided to stop the study as the study couldn't meet the study target number of patients and study objectives.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Korea, Ltd., Korea Clinical Trial study director
Janssen Korea, Ltd., Korea
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Graft vs Host Disease, run by Janssen Korea, Ltd., Korea at 8 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: After conducting pilot phase, the study team decided to stop the study as the study couldn't meet the study target number of patients and study objectives.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A and Part B: Percentage of Participants with Overall Response Rate (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.