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Study of Efficacy and Safety of Ruxolitinib in Chinese Participants With Corticosteroid-refractory Chronic Graft vs. Host Disease | Clinical Trials | Clareo Health

RECRUITINGPHASE4

Study of Efficacy and Safety of Ruxolitinib in Chinese Participants With Corticosteroid-refractory Chronic Graft vs. Host Disease

A Single-arm Multi-center Study of Ruxolitinib in Chinese Participants With Corticosteroid-refractory Chronic Graft Versus Host Disease After Allogeneic Stem Cell Transplantation

NCT06824103•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

The purpose of the study is to assess the efficacy and safety of ruxolitinib in Chinese adult and pediatric participants aged 12 years or older with corticosteroid-refractory chronic graft vs. host disease (SR-cGvHD).

Detailed Description

This is a single arm, multi-center, open label study which will enroll approximately 50 participants and investigate the efficacy and safety of ruxolitinib administered in adult and adolescent (≥12 years old) Chinese participants with SR-cGvHD. The total duration on study for an individual participant will be up to 164 weeks (approximately 3 years). The study consists of following periods, with each cycle comprised of 4 weeks (28 days): * Screening Period (Day -28 to Day -1) * Treatment period (Day 1 to Cycle 39/EOT) * Safety follow-up (Last dose +30 days) * Long-term survival follow-up period (EOT to 156 weeks on study).

Eligibility

Age

12 - 100 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Signed informed consent must be obtained prior to participation in the study.
•Male or female Chinese participants aged 12 or older at the time of informed consent
•Able to swallow tablets.- Have undergone alloSCT from any donor source (matched unrelated donor, sibling, haplo-identical) using bone marrow, peripheral blood stem cells, or cord blood. Recipients of non-myeloablative, myeloablative, and reduced intensity conditioning are eligible.
•Evident myeloid and platelet engraftment:
•* Absolute neutrophil count (ANC) \>1,000/mm3 AND
•* Platelet count ≥25,000/mm3
•Note: Use of growth factor supplementation and transfusion support is allowed during the trial, however, transfusion to reach a minimum platelet count for inclusion is not allowed during screening and at baseline.
•Participants with clinically diagnosed cGvHD staging of moderate to severe according to NIH Consensus Criteria (Jagasia et al 2015) prior to Cycle 1 Day 1.
•* Moderate cGvHD: at least one organ (not lung) with a score of 2, 3 or more organs involved with a score of 1 in each organ, or lung score of 1.
•* Severe cGvHD: at least 1 organ with a score of 3, or lung score of 2 or 3.
+5 more criteria

Exclusion Criteria

•Participants who have received two or more systemic treatments for cGvHD in addition to corticosteroids ± CNI for cGvHD.
•Participants who have received ROCK2 inhibitors for cGvHD.
•Participants that transition from active aGvHD to cGvHD without tapering off corticosteroids ± CNI and any systemic treatment
•Note: Participants receiving up to 30 mg by mouth once a day of hydrocortisone (i.e., physiologic replacement dose) of corticosteroids are allowed.
•Participants who were treated with prior JAK inhibitors for aGvHD; except when the participant achieved complete or partial response and has been off JAK inhibitor treatment for at least 8 weeks prior to Cycle 1 Day 1.
•Failed prior alloSCT within the past 6 months from Cycle 1 Day 1.
•Participants with relapsed primary malignancy, or who have been treated for relapse after the alloSCT was performed.
•SR-cGvHD occurring after a non-scheduled donor lymphocyte infusion (DLI) administered for pre-emptive treatment of malignancy recurrence. Participants who have received a scheduled DLI as part of their transplant procedure and not for management of malignancy relapse are eligible.
•Other protocol-defined inclusion/exclusion may apply.

Locations (19)

Novartis Investigative Site

Hefei, Anhui, China

Novartis Investigative Site

Guangzhou, Guangdong, China

Novartis Investigative Site

Guangzhou, Guangdong, China

Novartis Investigative Site

Nanning, Guangxi, China

Novartis Investigative Site

Guiyang, Guizhou, China

Novartis Investigative Site

Shijiazhuang, Hebei, China

Novartis Investigative Site

Zhengzhou, Henan, China

Novartis Investigative Site

Wuhan, Hubei, China

Novartis Investigative Site

Nanjing, Jiangsu, China

Novartis Investigative Site

Nanchang, Jiangxi, China

Key Dates

Start Date

September 9, 2025

Primary Completion Date

November 29, 2029

Completion Date

January 11, 2032

Last Updated

November 26, 2025

Enrollment

ESTIMATED participants

Conditions

Graft vs. Host DiseaseChronic Graft vs. Host DiseaseCorticosteroid-refractory Chronic Graft vs. Host Disease

Interventions

Ruxolitinib

DRUG

Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111 novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 26, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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