acute Graft Versus Host Disease (aGVHD)
Conditions
Interventions
80mg:Participants will receive oral AC-003, 80 milligrams (mg), twice daily (BID) for 28 days
160mg:Participants will receive oral AC-003, 160 milligrams (mg), twice daily (BID) for 28 days.
Sponsors
Hematology Hospital, Chinese Academy of Hospital Sciences (Institute of Hematology, Chinese Academy of Medical Sciences)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. age = 18 years, gender is not limited; 2. must be capable of understanding and willing to participate in this trial while signing an informed consent form; 3. have received hematopoietic stem cell transplantation (HSCT) from any donor source (including HLA-matched related or unrelated, haploidentical and umbilical cord donors) with any pretreatment regimen; 4. patients with grade I-IV aGVHD with a primary onset within 100 days of HSCT according to MAGIC criteria; 5. Glucocorticoids (methylprednisolone = 1 mg/kg/day, or equivalent dose of other hormonal agents) administered systemically for a period of = 72 hours; 6. ECOG PS score 0-2; 7. Expected survival = 4 weeks; 8. Laboratory tests meet the following criteria (growth factors, transfusion support, etc. are allowed within 7 days prior to the first dose): neutrophil count ANC = 0.5×10^9/L; platelet count PLT = 20×10^9/L; creatinine (CREA) = 1×ULN, creatinine clearance = 40 mL/min; AST and ALT = 3×ULN.
Exclusion criteria
Exclusion criteria: 1. recurrent acute Graft-Versus-Host-Disease; 2. patients with features of chronic GVHD (e.g., GVHD overlap syndrome or classic chronic GVHD); 3. patients who have received 2 or more allogeneic hematopoietic stem cell transplantation (allo-HSCT) treatments; 4. patients who have received 1 or more systemic anti-aGVHD therapies in addition to hormonal therapy for aGVHD (except for basic aGVHD prophylaxis); 5. patients who have undergone splenectomy; 6. patients who have received an unplanned donor lymphocyte infusion; 7. patients with progression of underlying disease or with active post-transplant lymphoproliferative disease, or relapse after receiving allo-HSCT; 8. unresolved grade 2 or greater toxicity or complication (other than GVHD) resulting from allo-HSCT; 9. corticosteroid therapy for indications other than GVHD, such as methylprednisolone > 1 mg/kg/day or an equivalent dose of other hormonal medication, within 7 days prior to enrollment; 10. severe organ dysfunction unrelated to GVHD, including: a) cholestatic disease or unresolved hepatic veno-occlusive disease (defined as persistent bilirubin abnormalities and persistent organ dysfunction not attributable to GVHD); b) clinically significant or uncontrolled cardiac disease, including unstable angina, acute myocardial infarction within 6 months prior to screening, NYHA classification III-IV congestive heart failure, left ventricular ejection fraction (EF) 480 ms; 18. any significant clinical or laboratory abnormality that, in the opinion of the investigator, compromises the safety evaluation; 19. patients who are unable to take tablets or are suspected to be allergic to similar drugs or their excipients; 20. participation in other pharmacologic or device clinical trials within 4 weeks prior to Screening; 21. female patients who are planning to become pregnant or who are pregnant or breastfeeding and patients who are unable to use effective contraception throughout the trial and for 3 months after the last dose of the drug 22. other conditions that, in the judgment of the investigator, make participation in this trial unsuitable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of treatment-related adverse events (AEs) ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective remission rate (ORR) at D28 after treatment initiation in aGVHD subjects;Objective remission rate (ORR) at D14 after treatment initiation in aGVHD subjects;Time to first remission in aGVHD subjects;Duration of first remission in aGVHD subjects;Event Free survival (EFS);Recurrence/progression rate of the original disease, mortality rate;Non-recurrent mortality rate (NRM);Proportion of subjects with improved target organ (liver, lower gastrointestinal tract) aGVHD grading with at least a grade 1 reduction in grading after treatment; | — |
Countries
China
Contacts
Public Contactxiaobin.zhou
Accro Bioscience (Suzhou) Limited
Outcome results
None listed