Graft-Versus-Host DiseaseNCT07594587
A Study of Ruxolitinib in Patients With Graft-Versus Host Disease
An observational study of Graft-Versus-Host Disease, run by Novartis Pharmaceuticals at 1 site in Japan.
Trial summary
This study aims to evaluate the safety and effectiveness of Jakavi® (ruxolitinib) in patients with acute graft-versus host disease (GVHD) and chronic GVHD in clinical practice. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Graft-Versus-Host Disease
- How many people
- 395 participants
- Where
- 1 siteJapan
- Study dates
- 11 May 2026to 15 May 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients treated with ruxolitinib for acute and chronic GVHD after its approval.
Who may be able to join
- Patients with acute and chronic GVHD
- Patients treated with ruxolitinib
Who cannot join
- None
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
About this study
Official title: Post-marketing Database Study in Patients With Graft-Versus Host Disease for JAKAVI Tablets
This study aims to evaluate the safety and effectiveness of Jakavi® (ruxolitinib) in patients with acute graft-versus host disease (GVHD) and chronic GVHD in clinical practice.
- Conditions
- Graft-Versus-Host Disease
- Keywords
- Ruxolitinib, GVHD
- Medical subject headings
- Graft vs Host Disease
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 |
|---|---|---|
| Ruxolitinib Cohort | Patients with acute and chronic GVHD treated with ruxolitinib. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Percentage of Patients With Common Terminology Criteria for Adverse Event (CTCAE) Grade ≥ 3 Infections
Grade ≥ 3 infections according to the CTCAE v5.0.
Measured: Up to 1 year
Number and Percentage of Deaths Due to Infection
Measured: Up to 1 year
Time to First Event
Time to first event is defined as the time from the start date of treatment with ruxolitinib to the first onset date of infection. Grade ≥ 4 infections according to the CTCAE v5.0.
Measured: Up to 1 year
Secondary outcomes (13)
Number and Percentage of CTCAE Grade ≥ 3 Infections
Grade ≥ 3 infections according to the CTCAE v5.0.
Measured: Up to 1 year
Odds Ratio of CTCAE Grade ≥ 3 Infections
Odds ratios of infections and their 95% confidence intervals summarized by risk factors for infection.
Measured: Up to 1 year
Number and Percentage of Patients With Adverse Events Other Than Infections
Measured: Up to 1 year
Number and Percentage of Patients who Died From Reasons Other Than Infection
Measured: Up to 1 year
Time to First Onset of Bone-related Events
The time to the first onset is defined as the time from the start date of treatment with ruxolitinib to the first onset date of CTCAE Grade ≥ 4 fracture or bone-related events other than fracture.
Measured: Up to 1 year
Overall Response Rate (ORR) Among Patients With Acute GVHD
ORR is defined as the proportion of patients with complete response (CR) or partial response (PR).
Measured: Day 28
Number and Percentage of Stages of Disorder for Each Organ Among Patients With Acute GVHD
Measured: Baseline, Day 28, up to 1 year
ORR Among Patients With Chronic GVHD
ORR is defined as the proportion of patients with CR or PR.
Measured: Month 6
Number and Percentage of Chronic GVHD Patients by Response
Response (CR, PR, mixed response, no change, progression) as entered into the database by the physician in accordance with the Japanese Society for Transplantation and Cellular Therapy guidelines for hematopoietic cell transplantation.
Measured: Baseline, Month 6, up to 1 year
Best Overall Response (BOR)
BOR is defined as the proportion of patients with CR or PR at any time point up to Month 12 of treatment.
Measured: Baseline, up to 1 year
Overall Survival
Overall survival is defined as the time from the start date of treatment with ruxolitinib to the date of death due to any cause.
Measured: Up to 1 year
Duration of Response (DOR) Among Chronic GVHD Patients
DOR is defined for patients who achieved a response (CR or PR) by Month 12 of treatment as the time from the date of first documented response by Month 12 to the date of a DOR event (progression of chronic GVHD, death, or initiation of new systemic therapy for chronic GVHD, whichever occurs first).
Measured: Up to 1 year
Time to Response (TTR) Among Chronic GVHD Patients
TTR is defined as the time from the start date of treatment with ruxolitinib to the date of first confirmed response (CR or PR).
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start11 May 2026
- Primary completion15 May 2030 (estimated)
- Study completion15 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft-Versus-Host DiseaseStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 395 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07594587
- Sponsor's protocol ID
- CINC424C1401
- Status last verified
- Jun 2026
- First submitted
- 11 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Database Study in Patients With Graft-Versus Host Disease for JAKAVI Tablets
- ClinicalTrials.gov ID
- NCT07594587
- Acronym / sponsor ID
- CINC424C1401
- Conditions
- Graft-Versus-Host Disease
- Keywords
- Ruxolitinib, GVHD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 395 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 11 May 2026 (actual)
- Primary completion
- 15 May 2030 (estimated)
- Study completion
- 15 May 2030 (estimated)
- First posted
- 19 May 2026 (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.
This study aims to evaluate the safety and effectiveness of Jakavi® (ruxolitinib) in patients with acute graft-versus host disease (GVHD) and chronic GVHD in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ruxolitinib Cohort | – | –Patients with acute and chronic GVHD treated with ruxolitinib. |
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated with ruxolitinib for acute and chronic GVHD after its approval.
Key inclusion criteria (2 listed)
- Patients with acute and chronic GVHD
- Patients treated with ruxolitinib
Key exclusion criteria (2 listed)
- None
- Other protocol-defined inclusion/exclusion criteria may apply.
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
Number and Percentage of Patients With Common Terminology Criteria for Adverse Event (CTCAE) Grade ≥ 3 Infections
Time frame: Up to 1 year
Grade ≥ 3 infections according to the CTCAE v5.0.
Number and Percentage of Deaths Due to Infection
Time frame: Up to 1 year
Time to First Event
Time frame: Up to 1 year
Time to first event is defined as the time from the start date of treatment with ruxolitinib to the first onset date of infection. Grade ≥ 4 infections according to the CTCAE v5.0.
13 secondary outcomes
Number and Percentage of CTCAE Grade ≥ 3 Infections
Time frame: Up to 1 year
Odds Ratio of CTCAE Grade ≥ 3 Infections
Time frame: Up to 1 year
Number and Percentage of Patients With Adverse Events Other Than Infections
Time frame: Up to 1 year
Number and Percentage of Patients who Died From Reasons Other Than Infection
Time frame: Up to 1 year
Time to First Onset of Bone-related Events
Time frame: Up to 1 year
Overall Response Rate (ORR) Among Patients With Acute GVHD
Time frame: Day 28
Number and Percentage of Stages of Disorder for Each Organ Among Patients With Acute GVHD
Time frame: Baseline, Day 28, up to 1 year
ORR Among Patients With Chronic GVHD
Time frame: Month 6
Number and Percentage of Chronic GVHD Patients by Response
Time frame: Baseline, Month 6, up to 1 year
Best Overall Response (BOR)
Time frame: Baseline, up to 1 year
Overall Survival
Time frame: Up to 1 year
Duration of Response (DOR) Among Chronic GVHD Patients
Time frame: Up to 1 year
Time to Response (TTR) Among Chronic GVHD Patients
Time frame: Up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No
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Graft vs Host Disease
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.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Graft-Versus-Host Disease, run by Novartis Pharmaceuticals at 1 site in Japan.
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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and Percentage of Patients With Common Terminology Criteria for Adverse Event (CTCAE) Grade ≥ 3 Infections (time frame: Up to 1 year). The study lists 3 primary outcomes in all. 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 8 Jun 2026.