This study aims to evaluate the efficacy and safety of PD-1 inhibitor, Azacitidine, and low-dose DLI in AML relapse After allogeneic hematopoietic stem cell transplantation
Patients with a diagnosis of AML relapse after allogeneic hematopoietic stem cell transplantation.
Adequate organ function.
Be able to understand and sign informed consent.
Age 18 to 60 years old.
Diagnosis of anther malignant disease.
Suspected or proven acute or chronic GVHD.
Proven central nervous system leukemia.
Prior treatment with anti-PD-1, anti-PD-L1, or DLI.
Single group
Azacitidine
DrugAzacitidine 75 mg/m2 subcutaneously once daily on days 1-7.
Donor lymphocyte infusion
Biological/VaccineThe 4 DLI doses (dose range: ±10%) of sib-matched donor HSCT patients were 1×10\^6/kg, 5×10\^6/kg, 1×10\^7/kg, 5×10\^7/kg; The 4 DLI doses (dose range: ±10%) of haploidentical or unrelated donor HSCT patients were 1×10\^5/kg, 5×10\^5/kg, 1×10\^6/kg, 5×10\^6/kg.
Camrelizumab
DrugCamrelizumab 200mg Q2W for sib-matched donor HSCT patients, 100mg Q2W for haploidentical or unrelated donor HSCT patients.
Overall response rate (ORR)
The overall response (completed remission, completed remission with incomplete blood count recovery)
Overall Survival (OS)
OS is measured from the time of enrollment to this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive.
Progression-Free Survival (PFS)
PFS is measured from the time of enrollment to this study to progression or death.
Adverse events
It is evaluated and graded according to CTCAE 5.0.
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The First Affiliated Hospital of Soochow University
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Collaborator
