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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04971551
Other study ID # ZGJAK013
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date December 2024
Est. completion date July 2025

Study information

Verified date March 2024
Source Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Contact Yongping Song, PhD
Phone +86-0371-65587320
Email songyongping001@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date July 2025
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Jaktinib Hydrochloride Tablets
Oral on an empty stomach

Locations

Country Name City State
China Henan Tumor Hospital Zhengzhou Henan

Sponsors (1)

Lead Sponsor Collaborator
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary Incidence and Severity of Adverse Events From the first day of Jaktinib treatment to 28 days after end of treatment, up to 24 months
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