Acute Graft-Versus-Host Disease
Conditions
Keywords
GVHD
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.
Interventions
Oral on an empty stomach
Sponsors
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) at Day 28 | Day 28 | Defined as the percentage of participants demonstrating a complete response (CR), or partial response (PR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | From the first day of Jaktinib treatment to death due to any cause，up to 24 months | Defined as the time from the first day of Jaktinib treatment to death due to any cause |
| Incidence and Severity of Adverse Events | From the first day of Jaktinib treatment to 28 days after end of treatment, up to 24 months | — |
Countries
China
Contacts
Primary ContactYongping Song, PhD
Outcome results
None listed