acute graft versus host disease
Conditions
Interventions
Gecacitinib group:treatment with gecacitinib,50mg bid
Sponsors
Sichuan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Voluntarily sign informed consent, aged >= 18 years at time of signing; 2.Recipients who underwent non-myeloablative, myeloablative, or reduced-intensity allo-HSCT from any donor source using bone marrow, peripheral blood stem cells, or umbilical cord blood; 3.Defined myeloid hematopoietic reconstitution and platelet reconstitution:ANC>0.5×10^9/L,PLT>25×10^9/L; 4.grade I to grade III (MAGIC standard) aGvHD patients; 5.ECOG score 0-2; 6.The expected survival time is more than 4 weeks; 7.swallowed tablet; 8.Ability to follow study and folow-up procedures;
Exclusion criteria
Exclusion criteria: 1.Patients who have received more than two allo-HSCT; 2.Patients with DLI or induced SR-aGVHD after prophylactic treatment of malignant tumor recurrence; 3.Patients who need to use other JAK inhibitors; 4.patients with active bleeding; 5.Patients diagnosed or suspected of chronic GVHD; 6.Unresolved toxicity or complications due to all-HSCT (except aGVHD); 7.Any significant clinical or laboratory abnormalities that may affect the safety evaluator; 8.Patients had a history of NHA grade III or IV congestive heart failure, uncontrolled or unstable angina or myocardial infarction, cerebrovascular accident, or pulmonary embolism within 6 months prior to screening; 9.Patients with arrhythmic disease requiring treatment at the time of screening, or with a QTc interval (QTcB) > 480ms; 10.The renal function was seriously damaged during screening (serum creatinine > 1.5 × ULN); 11.Patients with gastrointestinal ulcer diagnosed before transplantation, with a history of gastrointestinal resection, etc., which may affect drug absorption; 12.Patients who had not fully recovered from surgery within the first 4 weeks were screened; 13.Cholestatic disease, hepatic sinusoidal obstruction/hepatic veno-occlusive disease at the time of screening; 14.Active and uncontrolled viral infection at the time of screening; 15.patients with a history of active tuberculosis within 6 months before screening; 16.Patients with epilepsy or using psychotropic drugs, sedatives at the time of screening; 17.Female patients who plan to become pregnant or are pregnant or breastfeeding and patients who are unable to use effective contraception throughout the trial period; Male patients who did not use condoms during the administration and within 2 days after the last dose; 18.Patients with malignancy other than the transplanted tumor in the previous 5 years; 19.Treatment with drugs that anticoagulate or platelet function (except low molecular weight heparin); 20.Combined with other serious diseases, the researchers believe may affect patient safety or compliance; 21.Suspected allergy to gecacitinib hydrochloride, similar drugs, or any of its excipients; 22.Participants in clinical trials of other new drugs or medical devices within 4 weeks prior to screening; 23.The researcher judges that there are other factors that are not suitable for participating in the study; 24.Presence of uncontrolled active infections;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR at 28 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| Diachronic changes of ECOG PS score and FACT-BMT score compared with baseline;Overall survival at week 24;Incidence of adverse events;ORR at 1/2/6/8/12 weeks;Disease recurrence rate;Non-recurrent mortality;Duration of remission;Relapse-related mortality; | — |
Countries
China
Contacts
Public ContactHuang Xiaobing
Sichuan Provincial People's Hospital
Outcome results
None listed