This is an single center, single arm, phase 3 study to evaluate efficacy and safety of PD-1 Inhibitor combined with DNA methyltransferase inhibitor Azacytidine and HAG regimen for patients with relapsed and refractory acute myeloid leukemia.
Treatment for Acute Myeloid Leukemia(AML) that has not responded to treatment (refractory) or has returned after treatment (relapsed) often do not work. Researchers want to see if an immunotherapy drug, combined with a less intense chemotherapy, may be able to help.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Azacytidine 75mg/(m2.d) by IV on days 1-7 of every cycle. Anti-PD-1 mAb 200mg by IV on day 8 of every cycle. Homoharringtonine(HHT) 2mg/(m2.d) by IV on days 1-6 of every cycle Cytarabine 10mg/(m2.d) by SC on days 1-7 of every cycle Granulocyte colony-stimulating factor(G-CSF) 300ug/d by SC on days 1-7 of every cycle,until absolute neutrophil count(ANC) \> 5X109/L or white blood cell(WBC)\> 20X109/L.
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGComplete remission, Incomplete blood count recovery,Partial remission(CR+CRi+PR)
Number of Participants (Responders) Achieving CR+CRi+PR After the Eighth Cycle Treatments
Time frame: 8 months
Overall Response Rate (ORR)
Number of Participants (Responders) Achieving Overall Response Rate(ORR) After the Eighth Cycle Treatments
Time frame: 8 months
Overall survival (OS)
time from randomization to death from any cause
Time frame: 3 years
Event free survival(EFS)
The time between the beginning of the group and the occurrence of any event, including death, progression of the disease, chemotherapy regimen, conversion to chemotherapy, addition of other treatment, occurrence of fatal or intolerable side effects, etc
Time frame: 3 years
Progression free survival(PFS)
Time between the beginning of randomization and the progression (in any way) of tumorigenesis or (for any reason) death
Time frame: 3 years
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