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

Phase 2

Not yet recruiting

• Conditions: Acute Graft-Versus-Host Disease
• Interventions: Drug: Jaktinib Hydrochloride Tablets

• Registration Number: NCT04971551
• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-19
• Study First Submitted QC: 2021-07-19
• Study First Posted: 2021-07-21
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-06
• Study Start: 2024-12
• Primary Completion: 2025-06
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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 Cockcroft-Gault equation.
• Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Jaktinib treatment	Jaktinib Hydrochloride Tablets	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 .

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Henan Tumor Hospital; 🇨🇳 Zhengzhou, Henan, China