A Study of Jaktinib for the Treatment of Steroid-Refracto... | NCT04971551

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

NCT04971551

Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Status

Unknown status

Last Update Posted

Mar 6, 2024Actual

Enrollment

60Estimated

Phase

Phase 2

Conditions

Acute Graft-Versus-Host Disease

Interventions

Jaktinib Hydrochloride Tablets

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2024Estimated

Primary Completion Date

Jun 2025Estimated

Completion Date

Jul 2025Estimated

First Submitted Date

Jul 19, 2021

First Submission Date that Met QC Criteria

Jul 19, 2021

First Posted Date

Jul 21, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2024

Last Update Posted Date

Mar 6, 2024Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Jaktinib Hydrochloride Tablets	Drug	Oral on an empty stomach	Jaktinib treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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
Incidence and Severity of Adverse Events

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided