NCT07594587

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
395

participants targeted

Target at P75+ for all trials

Timeline
46mo left

Started May 2026

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 19, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

May 31, 2026

Expected
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2030

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2030

Last Updated

May 19, 2026

Status Verified

April 1, 2026

Enrollment Period

3.8 years

First QC Date

May 11, 2026

Last Update Submit

May 11, 2026

Conditions

Graft-Versus-Host Disease

Keywords

RuxolitinibGVHD

Outcome Measures

Primary Outcomes (3)

  • 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.

    Up to 1 year

  • Number and Percentage of Deaths Due to Infection

    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.

    Up to 1 year

Secondary Outcomes (13)

  • Number and Percentage of CTCAE Grade ≥ 3 Infections

    Up to 1 year

  • Odds Ratio of CTCAE Grade ≥ 3 Infections

    Up to 1 year

  • 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

  • +8 more secondary outcomes

Study Arms (1)

Ruxolitinib Cohort

Patients with acute and chronic GVHD treated with ruxolitinib.

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treated with ruxolitinib for acute and chronic GVHD after its approval.

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2026

First Posted

May 19, 2026

Study Start (Estimated)

May 31, 2026

Primary Completion (Estimated)

March 15, 2030

Study Completion (Estimated)

March 15, 2030

Last Updated

May 19, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share