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

NCT04971551 | Not Yet Recruiting Phase 2

• 1 other identifier: ZGJAK013
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

GVHD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Overall Survival (OS)

  From the first day of Jaktinib treatment to death due to any cause，up to 24 months

• Incidence and Severity of Adverse Events

  From the first day of Jaktinib treatment to 28 days after end of treatment, up to 24 months

Study Arms (1)

Jaktinib treatment

EXPERIMENTAL

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

Interventions

Jaktinib Hydrochloride Tablets DRUG

Oral on an empty stomach

Also known as: Jaktinib

Jaktinib treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

Henan Tumor Hospital

Zhengzhou, Henan, China

Location

Study Officials

• Yongping Song, PhD

  Henan Tumor Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongping Song, PhD

CONTACT

+86-0371-65587320; songyongping001@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: July 21, 2021
• Study Start: December 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: March 6, 2024

Record last verified: 2024-03

Locations

CN (1)