Study of Efficacy and Safety of Ruxolitinib in Patients With Grade II to IV Steroid-refractory Acute Graft vs. Host Disease
NCT ID: NCT06462469
Last Updated: 2025-11-25
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
36 participants
INTERVENTIONAL
2024-07-04
2028-02-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ruxolitinib
Participants will receive ruxolitinib orally of 10 mg BID daily (given as two 5-mg tablets, approximately 12 hours apart).
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
* 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.
* Clinically diagnosed Grades II to IV acute GvHD as per standard criteria occurring after alloSCT requiring systemic immune suppressive therapy.
* Evident myeloid and platelet engraftment (confirmed within 48 hours prior to study treatment (ruxolitinib) start):
* Confirmed diagnosis of steroid refractory aGvHD defined as participants administered systemic corticosteroids (methylprednisolone at least 1 mg/kg/day \[or equivalent prednisone dose at least 1.25 mg/kg/day\]), given alone or combined with calcineurin inhibitors (CNI) and either:
1. Progression based on organ assessment after at least 3 days compared to organ stage at the time of initiation of systemic corticosteroid +/- CNI for the treatment of Grade II to IV aGvHD. OR
2. Failure to achieve at a minimum partial response based on organ assessment after 7 days compared to organ stage at the time of initiation of systemic corticosteroid +/-CNI for the treatment of Grade II to IV. OR
3. Participants who fail corticosteroid taper defined as fulfilling either one of the following criteria:
* Requirement for an increase in the corticosteroid dose to methylprednisolone ≥ 1 mg/kg/day (or equivalent prednisone dose ≥ 1.25 mg/kg/day). OR
* Failure to taper the methylprednisolone dose to \< 0.5 mg/kg/day (or equivalent prednisone dose \<0.6 mg/kg/day) for a minimum of 7 days.
Exclusion Criteria
* Clinical presentation resembling de novo chronic GvHD or GvHD overlap syndrome with both acute and chronic GvHD features.
* Failed prior alloSCT within the past 6 months. Presence of relapsed primary malignancy after the alloSCT was performed.
* Presence of an active uncontrolled infection including significant bacterial, fungal, viral or parasitic infection requiring treatment.
* SR-aGvHD occurring after non-scheduled donor lymphocyte infusion (DLI) administered for pre-emptive treatment of malignancy recurrence. Note: Participants who have received a scheduled DLI as part of their transplant procedure and not for management of malignancy relapse are eligible.
* Presence of significant respiratory disease, severely impaired renal function, clinically significant or uncontrolled cardiac disease, unresolved cholestatic and liver disorders (not attributable to aGvHD). Disorders and/or current therapy with medications that interfere with coagulation or platelet function.
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
Guangzhou, Guangdong, China
Novartis Investigative Site
Guangzhou, Guangdong, China
Novartis Investigative Site
Zhengzhou, Henan, China
Novartis Investigative Site
Wuhan, Hubei, China
Novartis Investigative Site
Changchun, Jilin, China
Novartis Investigative Site
Xian, Shanxi, China
Novartis Investigative Site
Chengdu, Sichuan, China
Novartis Investigative Site
Hangzhou, Zhejiang, China
Novartis Investigative Site
Beijing, , China
Novartis Investigative Site
Beijing, , China
Novartis Investigative Site
Beijing, , China
Novartis Investigative Site
Beijing, , China
Novartis Investigative Site
Dalian, , China
Novartis Investigative Site
Fuzhou, , China
Novartis Investigative Site
Shanghai, , China
Novartis Investigative Site
Taian, , China
Novartis Investigative Site
Tianjin, , China
Countries
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Central Contacts
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Novartis Pharmaceuticals
Role: CONTACT
Other Identifiers
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CINC424C2416
Identifier Type: -
Identifier Source: org_study_id
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