Combined Inhibition of PD-1 and DNA Hypomethylating Agent +/- Chemotherapy in High-risk AML or Elderly Patients With AML Who Are Unfit for Intensive Chemotherapy

• Status: Recruiting
• Trial end date: 2022-08-30

Summary

This phase II trial studies how well tislelizumab combined with DNA hypomethylation agent +/- CAG regimen (cytarabine, idarubicin / Aclarithromycin, rhG-CSF/ PEG-rhG-CSF) work in treating patients with high-risk acute myeloid leukemia (AML) or AML patients older than 60 years of age who are unfit for standard-dose chemotherapy. The expressions of PD-1 and PD-L1 are increased in AML cells. However, blocking the immune checkpoint alone has limited efficacy as a single agent in highly proliferative leukemia cells. During the recovery period after cytotoxic chemotherapy, the activation of PD-1/PD-L1 pathway may be increased and DNA hypomethylation agents can also up-regulate PD-1, PD-L1 and PD-L2 in AML patients. The up-regulation and activation of above immune checkpoint molecules are related to chemotherapy resistance. Therefore, adding chemotherapy and epigenetic regulation agents to Immune checkpoint blockade therapy may work better through overcoming drug resistance in AML treatment.

• Phase: Phase 2

Details

• Lead Sponsor: Chinese PLA General Hospital
• Treatments: Azacitidine; Cytarabine; Decitabine; Idarubicin; Lenograstim; Sargramostim