Back to resultsA Study of Jaktinib for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease.
Primary Purpose
Acute Graft-Versus-Host Disease
Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Jaktinib Hydrochloride Tablets
Sponsored by
About this trial
This is an interventional treatment trial for Acute Graft-Versus-Host Disease focused on measuring GVHD
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 Cockroft-Gault equation.
- Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds.
Sites / Locations
- Henan Tumor Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Jaktinib treatment
Arm Description
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 .
Outcomes
Primary Outcome Measures
Overall Response Rate (ORR) at Day 28
Defined as the percentage of participants demonstrating a complete response (CR), or partial response (PR).
Secondary Outcome Measures
Overall Survival (OS)
Defined as the time from the first day of Jaktinib treatment to death due to any cause
Incidence and Severity of Adverse Events
Full Information
NCT ID
NCT04971551
First Posted
July 19, 2021
Last Updated
November 28, 2022
Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
1. Study Identification
Unique Protocol Identification Number
NCT04971551
Brief Title
A Study of Jaktinib for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease.
Official Title
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
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Graft-Versus-Host Disease
Keywords
GVHD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Jaktinib treatment
Arm Type
Experimental
Arm Description
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 .
Intervention Type
Drug
Intervention Name(s)
Jaktinib Hydrochloride Tablets
Other Intervention Name(s)
Jaktinib
Intervention Description
Oral on an empty stomach
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR) at Day 28
Description
Defined as the percentage of participants demonstrating a complete response (CR), or partial response (PR).
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Defined as the time from the first day of Jaktinib treatment to death due to any cause
Time Frame
From the first day of Jaktinib treatment to death due to any cause，up to 24 months
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 Cockroft-Gault equation.
Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yongping Song, PhD
Phone
+86-0371-65587320
Email
songyongping001@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongping Song, PhD
Organizational Affiliation
Henan Tumor Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henan Tumor Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongping Song, PhD
Phone
+86-0371-65587320
12. IPD Sharing Statement
Learn more about this trial
A Study of Jaktinib for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease.
We'll reach out to this number within 24 hrs