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

NCT ID: NCT04971551

Last Updated: 2024-03-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2025-07-31

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.

Conditions

Acute Graft-Versus-Host Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 .

Group Type: EXPERIMENTAL

Jaktinib Hydrochloride Tablets

Intervention Type: DRUG

Oral on an empty stomach

Interventions

Jaktinib Hydrochloride Tablets

Oral on an empty stomach

Intervention Type: DRUG

Other Intervention Names

Jaktinib

Eligibility 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.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yongping Song, PhD

Role: PRINCIPAL_INVESTIGATOR

Henan Tumor Hospital

Locations

Henan Tumor Hospital

Zhengzhou, Henan, China

Countries

China

Central Contacts

Yongping Song, PhD

Role: CONTACT

songyongping001@126.com

+86-0371-65587320

Facility Contacts

Yongping Song, PhD

Role: primary

+86-0371-65587320

Other Identifiers

ZGJAK013

Identifier Type: -

Identifier Source: org_study_id