Neoplasms

Blood and Lymph Conditions

All Conditions

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasm, Residual

Neoplasms by Histologic Type

Hematologic Diseases

Neoplastic Processes

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Cytarabine

Tislelizumab

Azacitidine

Decitabine

Lenograstim

Idarubicin

Antimetabolites

Antiviral Agents

Immunosuppressive Agents

Immunologic Factors

Enzyme Inhibitors

Antineoplastic Agents, Immunological

Adjuvants, Immunologic

Anti-Bacterial Agents

Antibiotics, Antitubercular

Decitabine, 20 mg/m2/d, IV, on days 1-5; or Azacitidine, 75 mg/m2/d,SC, on days 1-7.

Aclamycin hydrochloride, 20 mg/d, IV, on day 1, 3, and 5 (For relapse/resistance AML, on days 1-5.); or idarubicin hydrochloride,10 mg/d, IV, on day 1, 3, and 5.

Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Cytarabine,100 mg, IV, q12h/d. For patients with one of the following conditions, cytarabine,10 mg, SC, q12h/d: (1) There are obvious heart, lung, and kidney complications; (2) Bone marrow is hypoproliferative; (3) Age\> 75 years old; (4) Age\> 60 years old who are unfit for standard-dose chemotherapy.

Recombinant human granulocyte colony stimulating factor injection, 5 μg/kg, SC, from day 0 to stop of chemotherapy after the WBC count exceeds 10.0×10\^9/L; or Pegylated recombinant human granulocyte stimulating factor injection Liquid, 100 μg/kg, SC, on day 0.

Tislelizumab,200 mg, IV, on the next day after chemotherapy was stopped.

Tislelizumab combined with DNA demethylation agent +/- CAG regimen

Dai-hong Liu, MD

Xiao-ning Gao, MD

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.

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

A Phase II, Single Arm Study of Tislelizumab Combined With DNA Demethylation Agent +/- CAG Regimen in the Treatment of Patients With High-risk AML or AML Patients Older Than 60 Years of Age Who Are Unfit for Intensive Chemotherapy

The percentage of subjects with complete remission (CR) and incomplete hematological recovery (CRi) within 2 medication cycles.

The time from first obtaining CR or CRi to relapse or death from AML.

the time from the day of treatment to relapse, progression or death (whichever occurs first is preferred).

The time from the day of treatment to death.

The percentage of subjects with CR and CRi (calculated based on the best response) at the 28th day after treatment.

The incidence of adverse events will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

The expression levels of PD-L1 in acute myeloid leukemia bone marrow cells will be assessed at the 28th day after each medication cycle.

Chinese PLA General Hospital

Director

Spots Global Cancer Trial Database for acute myeloid leukemia, elderly, unfit