Recurrent/refractory acute myeloid leukemia
Conditions
Interventions
Experimental group:Sotoclera + azacitidine +HAG (homoharringtonine, cytarabine, granulocyte colony-stimulating factor)
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Meet the following diagnostic criteria for relapsed/refractory acute myeloid leukemia. (Refractory AML was defined as failure to achieve composite complete remission (cCR, CR/CRh/CRi) after 2 cycles of induction therapy. cCR was not achieved with 6 cycles of induction therapy or 180 days, whichever occurred first, if the front-line therapy was a low-intensity regimen. Relapsed AML was defined as the presence of leukemia cells in peripheral blood or bone marrow blasts > 5% again, or extramedullary leukemic cell infiltration after cCR). 2. Aged 18 to 75 years; 3. Eastern Cooperative Oncology Group Performance Score (ECOG PS) of 2 or lower; 4. The following organ functional conditions must meet:(1) Liver function (total bilirubin =30 mL/min); (3) Cardiac function (ejection fraction >= 50%); 5.Women of childbearing age must have a negative serum pregnancy test within 7 days prior to the first dose. In addition, they must use an effective contraceptive method before the first dose of study drug, during study treatment and for at least 180 days after the last dose of study drug; 6.Men of reproductive age must use an effective method of contraception during the study treatment and for at least 90 days after the last dose of study drug. Sperm donation is not allowed during this period; 7.The patient is fully informed of the study and obtains an informed consent form (ICF) signed by the patient or his/her legal representative to comply with the study protocol and follow-up process;
Exclusion criteria
Exclusion criteria: 1.Patients with APL; 2.Malignant tumor in the past 2 years, except for cured localized skin cancer, superficial bladder cancer, cervical cancer or cancer in situ of breast cancer, and localized prostate cancer with Gleason score <= 6; 3.HIV is known to be positive; 4.Patients who are positive for hepatitis B or hepatitis C infection, except those whose viral load cannot be detected within 3 months (Note: patients with Hepatitis B core antibody positive [HBcAb+ ] but Hepatitis B surface antigen negative [HBsAg-] can only meet the condition if the DNA of hepatitis B virus (HBV) cannot be detected with a sensitivity <= 20 IU/mL. In this case, patients should receive regular monitoring of HBV DNA and receive prophylactic antiviral drug treatment according to the central diagnosis and treatment routine; patients with hepatitis C virus (HCV) antibody+ are only eligible if they cannot detect HCV RNA and are willing to monitor HCV reactivation; 5.Uncontrolled concomitant diseases, including but not limited to: ongoing or active uncontrolled infections, cardiovascular disease, or psychiatric conditions/social conditions that would limit compliance with study requirements; 6.Patients who receive any moderate or strong CYP3A4 inhibitor (7 days or 5 half-lives, whichever is longer) or moderate or strong CYP3A4 inducer (14 days or 5 half-lives, whichever is longer) treatment before the first use of sonrotoclax; 7.Patients with previous venetoclax refractory and early relapse, that is, patients with recurrence time <12 months; 8.Patients who are known to have hypersensitivity reactions to any component in the study protocol; 9.Known involvement of the central nervous system in AML; 10.Previously received organ, bone marrow, or peripheral blood stem cell transplantation; 11.Patients who are simultaneously participating in another therapeutic clinical study; 12.Pregnant or lactating women, or patients who plan to have children during the study period;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year OS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Early mortality rate;Evaluate the complete remission rate at the end of induction therapy according to the 2022 ELN criteria;Event free survival;Relapse free survival;Duration of continuous complete remission;Overall survival;Minimal residual disease-negative complete remission rate at the end of induction therapy and at the end of consolidation/maintenance therapy.; | — |
Countries
China
Contacts
Public ContactYin Qingsong
Henan Cancer Hospital
Outcome results
None listed