A Study of Ruxolitinib in Patients With Graft-Versus Host Disease

Primary outcomes

• Number and Percentage of Patients With Common Terminology Criteria for Adverse Event (CTCAE) Grade ≥ 3 Infections [Up to 1 year]: Grade ≥ 3 infections according to the CTCAE v5.0.
• Number and Percentage of Deaths Due to Infection [Up to 1 year]
• Time to First Event [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.

Secondary outcomes

• Number and Percentage of CTCAE Grade ≥ 3 Infections [Up to 1 year]: Grade ≥ 3 infections according to the CTCAE v5.0.
• Odds Ratio of CTCAE Grade ≥ 3 Infections [Up to 1 year]: Odds ratios of infections and their 95% confidence intervals summarized by risk factors for infection.
• Number and Percentage of Patients With Adverse Events Other Than Infections [Up to 1 year]
• Number and Percentage of Patients who Died From Reasons Other Than Infection [Up to 1 year]
• Time to First Onset of Bone-related Events [Up to 1 year]: 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.
• Overall Response Rate (ORR) Among Patients With Acute GVHD [Day 28]: ORR is defined as the proportion of patients with complete response (CR) or partial response (PR).
• Number and Percentage of Stages of Disorder for Each Organ Among Patients With Acute GVHD [Baseline, Day 28, up to 1 year]
• ORR Among Patients With Chronic GVHD [Month 6]: ORR is defined as the proportion of patients with CR or PR.
• Number and Percentage of Chronic GVHD Patients by Response [Baseline, Month 6, up to 1 year]: 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.
• Best Overall Response (BOR) [Baseline, up to 1 year]: BOR is defined as the proportion of patients with CR or PR at any time point up to Month 12 of treatment.
• Overall Survival [Up to 1 year]: Overall survival is defined as the time from the start date of treatment with ruxolitinib to the date of death due to any cause.
• Duration of Response (DOR) Among Chronic GVHD Patients [Up to 1 year]: 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).
• Time to Response (TTR) Among Chronic GVHD Patients [Up to 1 year]: TTR is defined as the time from the start date of treatment with ruxolitinib to the date of first confirmed response (CR or PR).

Sex: All, ages: 0 Years to any

Inclusion Criteria:

* Patients with acute and chronic GVHD
* Patients treated with ruxolitinib

Exclusion Criteria:

None

Other protocol-defined inclusion/exclusion criteria may apply.

• Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals