A Study of Jaktinib for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease.

Study Overview
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Brief Summary
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This is an single-arm, Phase II multi-center study. The purpose of this study is to assess the efficacy and safety of Jaktinib in subjects with Grades II to IV steroid-refractory acute graft-versus-host disease.

Official Title
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A Phase 2 ,Safety and Efficacy Study of Jaktinib Hydrochloride Tablets for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease.

Conditions
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Acute Graft-Versus-Host Disease

Intervention / Treatment
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* Drug: Jaktinib Hydrochloride Tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have undergone first allogeneic hematopoietic stem cell transplantation (allo-HSCT) from any donor source using bone marrow, peripheral blood stem cells, or cord blood for hematologic malignancies. Recipients of nonmyeloablative and myeloablative conditioning regimens are eligible. Clinically suspected Grades II to IV acute GVHD according to NCCN guidelines 2020 V2.0, occurring after allo-HSCT with any conditioning regimen and any anti-GVHD prophylactic program. Subjects with steroid-refractory acute GVHD, defined as any of the following: Subjects with progressive GVHD (ie, increase in stage in any organ system or any new organ involvement) after 3-5 days of primary treatment with methylprednisolone ≥ 2 mg/kg per day (or equivalent) ± Calcineurin inhibitors（CNI）；Subjects with GVHD that has not improved (ie, decrease in stage in at least 1 involved organ system) after 5-7 days of primary treatment with methylprednisolone ≥ 2 mg/kg per day (or equivalent) ± Calcineurin inhibitors（CNI）；Subjects who Corticosteroid dependence（ie, begin corticosteroids at 2.0 mg/kg per day, demonstrate response, but progress before decrease from the initial starting dose of corticosteroids is achieved）. ECOG: 0-2； Life expectancy > 4 weeks； Ability for oral drug intake； Willingness to comply with all study visits and procedures. Exclusion Criteria: Has received more than 2 allo-HSCT. Acute GvHD occurring after non-scheduled donor leukocyte infusion (DLI) administered. Has received more than 1 systemic treatment in addition to corticosteroids for acute GVHD. Presence of an active uncontrolled infection. Serum creatinine > 1.5 ULN or creatinine clearance < 30 mL/min calculated by Cockroft-Gault equation. Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Jaktinib treatment<br>Participants began oral administration of Jaktinib at 75mg twice daily (BID); if stable after the first 3 days of treatment, the dose could be increased to 100mg BID Or continue 75mg BID treatment . | Drug: Jaktinib Hydrochloride Tablets<br>* Oral on an empty stomach<br>* Other names: Jaktinib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate (ORR) at Day 28 | Defined as the percentage of participants demonstrating a complete response (CR), or partial response (PR). | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | Defined as the time from the first day of Jaktinib treatment to death due to any cause | From the first day of Jaktinib treatment to death due to any cause，up to 24 months | 
| Incidence and Severity of Adverse Events |  | From the first day of Jaktinib treatment to 28 days after end of treatment, up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GVHD