Study of Efficacy and Safety of Ruxolitinib in Chinese Participants With Corticosteroid-refractory Chronic Graft vs. Host Disease
NCT ID: NCT06824103
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
50 participants
INTERVENTIONAL
2025-09-09
2032-01-11
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ruxolitinib
Chinese participants (adult and pediatric) who will receive ruxolitinib daily.
Ruxolitinib
Ruxolitinib is taken orally daily at 10 mg BID, given as two 5 mg tablets.
Interventions
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Ruxolitinib
Ruxolitinib is taken orally daily at 10 mg BID, given as two 5 mg tablets.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* Participants currently receiving systemic corticosteroids for the treatment of cGvHD for a duration of \< 12 months prior to Cycle 1 Day 1, and have a confirmed diagnosis of corticosteroid refractory cGvHD defined per 2014 NIH consensus criteria (Martin et al 2015) irrespective of the concomitant use of a calcineurin inhibitor, as follows:
* A lack of response or disease progression after administration of minimum prednisone 1 mg/kg/day for at least 1 week (or equivalent) OR
* Disease persistence without improvement despite continued treatment with prednisone at \>0.5 mg/kg/day or 1 mg/kg/every other day for at least 4 weeks (or equivalent) OR
* Increase to prednisone dose to \>0.25 mg/kg/day after two unsuccessful attempts to taper the dose (or equivalent)
* Participants has Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Exclusion Criteria
* 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.
12 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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
Novartis Investigative Site
Chengdu, Sichuan, China
Novartis Investigative Site
Hangzhou, Zhejiang, China
Novartis Investigative Site
Ningbo, Zhejiang, China
Novartis Investigative Site
Wenzhou, Zhejiang, China
Novartis Investigative Site
Beijing, , China
Novartis Investigative Site
Beijing, , China
Novartis Investigative Site
Changsha, , China
Novartis Investigative Site
Shanghai, , China
Novartis Investigative Site
Shanhecun, , China
Countries
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Central Contacts
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Novartis Pharmaceuticals
Role: CONTACT
Other Identifiers
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CINC424D2413
Identifier Type: -
Identifier Source: org_study_id
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