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.
Full Title of Study: “A Phase 2 ,Safety and Efficacy Study of Jaktinib Hydrochloride Tablets for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease.”
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: June 2023
- Drug: Jaktinib Hydrochloride Tablets
- Oral on an empty stomach
Arms, Groups and Cohorts
- 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 .
Clinical Trial Outcome Measures
- Overall Response Rate (ORR) at Day 28
- Time Frame: Day 28
- Defined as the percentage of participants demonstrating a complete response (CR), or partial response (PR).
- Overall Survival (OS)
- Time Frame: 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
- Time Frame: From the first day of Jaktinib treatment to 28 days after end of treatment, up to 24 months
Participating in This Clinical Trial
- 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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Provider of Information About this Clinical Study
- Overall Official(s)
- Yongping Song, PhD, Principal Investigator, Henan Tumor Hospital
- Overall Contact(s)
- Yongping Song, PhD, +86-0371-65587320, email@example.com
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