Recruiting NCT07594587
A Study of Ruxolitinib in Patients With Graft-Versus Host Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Graft-Versus-Host Disease. Basic parameters: from 0 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Post-marketing Database Study in Patients With Graft-Versus Host Disease for JAKAVI Tablets
Overview
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.
Primary outcome measures
- Number and Percentage of Patients With Common Terminology Criteria for Adverse Event (CTCAE) Grade ≥ 3 Infections [Time frame: Up to 1 year]
- Number and Percentage of Deaths Due to Infection [Time frame: Up to 1 year]
- Time to First Event [Time frame: Up to 1 year]
Secondary outcome measures (12)
- 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]
Eligibility criteria
Inclusion criteria
- Patients with acute and chronic GVHD
- Patients treated with ruxolitinib
Exclusion criteria
None
Other protocol-defined inclusion/exclusion criteria may apply.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Japan · 1 center
- Novartis — Tokyo
Identifiers
NCT: NCT07594587 · CINC424C1401