A Study of Jaktinib for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease.
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Jaktinib treatment 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
Oral on an empty stomach
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Overall Response Rate (ORR) at Day 28 [Day 28]
Defined as the percentage of participants demonstrating a complete response (CR), or partial response (PR).
Secondary Outcome Measures
- Overall Survival (OS) [From the first day of Jaktinib treatment to death due to any cause，up to 24 months]
Defined as the time from the first day of Jaktinib treatment to death due to any cause
- Incidence and Severity of Adverse Events [From the first day of Jaktinib treatment to 28 days after end of treatment, up to 24 months]
Eligibility Criteria
Criteria
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.
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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.
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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）.
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ECOG: 0-2；
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Life expectancy > 4 weeks；
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Ability for oral drug intake；
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Willingness to comply with all study visits and procedures.
Exclusion Criteria:
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Has received more than 2 allo-HSCT.
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Acute GvHD occurring after non-scheduled donor leukocyte infusion (DLI) administered.
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Has received more than 1 systemic treatment in addition to corticosteroids for acute GVHD.
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Presence of an active uncontrolled infection.
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Serum creatinine > 1.5 ULN or creatinine clearance < 30 mL/min calculated by Cockroft-Gault equation.
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Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Henan Tumor Hospital | Zhengzhou | Henan | China |
Sponsors and Collaborators
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Investigators
- Principal Investigator: Yongping Song, PhD, Henan Tumor Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ZGJAK013