This is an open-label, single arm, phase 2 study to evaluate efficacy and safety of PD1 inhibitor Camrelizumab(SHR-1210) combined with DNA methyltransferase inhibitor decitabine in elderly patients with relapse and refractory acute myeloid leukemia.
In this single-center, open-label, nonrandomized, no control, prospective clinical trial, 29 relapsed or refractory acute myeloid leukemia patients will be enrolled. Patients will be administered Camrelizumab(SHR-1210) at D1 and D15 and decitabine at D1-5. Treatment repeats every 28 days until disease progression or unacceptable toxicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
A humanized monoclonal immunoglobulin
A DNA methyltransferase inhibitor
Overall response rate
CR, CRi, and morphologic leukemia-free state (MLFS)
Time frame: 6 months
Complete remission (CR) rate
Blast and promyelocytic leukemia less than 5% in bone marrow
Time frame: 6 months
Progress-free survival (PFS)
PFS is defined from the date of entry on study until disease progression, including treatment failure, relapse from CR, or death from any causes.
Time frame: 2 years
Overall survival (OS)
OS is defined for patients entering the study as time to death of all causes.
Time frame: 2 years
6-month overall survival rate
To evaluate overall survival rate at 6 months from study entry.
Time frame: 6 months
12-month overall survival rate
To evaluate overall survival rate at 12 months from study entry.
Time frame: 12 months
Hematological and non-hematological toxicity
Assessed according to the Common Terminology Criteria for Adverse Events Version 4.03.
Time frame: 2 years
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