PD-1 Inhibitor Combined With Azacytidine and Homoharringtonine Cytarabine G-CSF for Refractory or Relapsed AML

  • End date
    Jan 1, 2024
  • participants needed
  • sponsor
    The First Affiliated Hospital of Soochow University
Updated on 29 April 2021


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 LeukemiaAML 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.

Condition Acute myeloid leukemia, Immunotherapy, Acute Myelogenous Leukemia (AML), Relapsed Adult AML, Refractory Leukemia, immunotherapies, acute myelogenous leukemia, anll, acute myeloblastic leukemia
Treatment Visilizumab, Visilizumab
Clinical Study IdentifierNCT04722952
SponsorThe First Affiliated Hospital of Soochow University
Last Modified on29 April 2021


Yes No Not Sure

Inclusion Criteria

Chinese guidelines for the diagnosis and treatment of relapsed and refractory acute myeloid leukemia (2017 edition)excludes acute promyelocytic leukemia (M3APL)
Hematopoietic stem cell transplantation 3 months, Discontinue immunosuppressant 3 weeks, Patients without graft-versus-host disease
Be at least 18 years of age on day of signing informed consent
Have a performance status of less than or equal to 2 on the Eastern Cooperative Oncology GroupECOG Performance Scale
Demonstrate adequate organ function as defined below, all screening labs should be performed before treatment initiation
ALT(SGPT) less than or equal to 2.5 Upper Limit of NormaULN
AST (SGOT) less than or equal to 2.5 ULN
Serum total bilirubin Less than or equal to 2.0 ULN Note: If total bilirubin >2.0ULN, subjects with Gilbert syndrome records are allowed to join the group
Serum Creatinine 30 mL/min
Total white blood cell (WBC) count 10,000/L Note: hydroxyurea therapy is allowed to reduce white blood cells to meet this inclusion criteria.white blood cells should be determined 24 hours after the last hydroxyurea administration. Final hydroxyurea administration should not 3 days prior to the first azacytidine administration
Treatment without anthracycline or demethylation. Ability to comprehend the investigational nature of the study and provide informed consent

Exclusion Criteria

Patients with chronic myeloid leukemiaAML of other myeloproliferative disorders Malignant neoplasms with other progression Those who can not control severe infections and other underlying diseases can not tolerate chemotherapy Patients with cardiac insufficiency ejection fraction (EF)<30%New York Heart AssociationNYHA standardsCardiac insufficiency II or above Patients with liver and kidney dysfunctionSerum bilirubin (SB)2mg/dlAST is 2.5 times higher than normal upper limit, serum creatinine (SCr) is more than 2.5 mg/dl Serious mental illness uncooperative Refusal to join the study
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