Clinical trial NCT04971551: 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
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Acute Graft-Versus-Host Disease
Keywords: GVHD
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2021-07-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Overall Response Rate (ORR) at Day 28
timeFrame: Day 28
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From the first day of Jaktinib treatment to death due to any cause，up to 24 months
measure: Incidence and Severity of Adverse Events
timeFrame: From the first day of Jaktinib treatment to 28 days after end of treatment, up to 24 months
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Tumor Hospital
state: Henan
Study officials:
affiliation: Henan Tumor Hospital
name: Yongping Song, PhD
role: PRINCIPAL_INVESTIGATOR
References: