acute myeloid leukemia
Conditions
Interventions
Experimental Group:Cyclophosphamide and PD-1 Monoclonal Antibody Combined with 3+7 Regimen(Idarubicin +cytosine-1-beta-D-arabinofuranoside)
Control Group:Idarubicin +cytosine-1-beta-D-arabinofuranoside
Sponsors
Medical Center of Hematology, Xinqiao Hospital, Army Medical University, Chongqing, China
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: ? Patients fully understand the study, voluntarily participate, and sign the Informed Consent Form (ICF); ? Patients aged 18-60 years (inclusive) with newly diagnosed acute myeloid leukemia (AML) in accordance with the World Health Organization (WHO) criteria, regardless of gender; ? ECOG performance status score = 2, or KPS score = 90, or PS score = 1; ? No concurrent active second malignant tumor; ? Estimated survival time > 3 months; ? No prior radiotherapy, chemotherapy, targeted therapy, hematopoietic stem cell transplantation, or any other anti-tumor treatment within 4 weeks before enrollment (for patients with hyperleukocytic leukemia, hydroxyurea and low-dose cytarabine are permitted for tumor burden reduction); ? Classified as high-risk according to the NCCN 2024 AML Guidelines; ? Female participants of childbearing age must undergo a serum pregnancy test within 14 days before the first administration of the study drug, with a negative result; all participants (both male and female) must agree to use regular and effective contraceptive measures throughout the study period.
Exclusion criteria
Exclusion criteria: ? Confirmed acute promyelocytic leukemia (APL); BCR-ABL-positive leukemia; ? Patients who have received live vaccines (including attenuated live vaccines) within 4 weeks before randomization and/or plan to receive live vaccines after enrollment; ? Patients with low to intermediate risk stratification; ? Patients with severe heart disease or abnormal lung function that affects survival; ? Patients with concurrent active second primary malignancy; ? Presence of uncontrolled active infection before the first administration of the study drug; ? Patients who cannot ensure completion of the required treatment plan and follow-up observations; ? Patients deemed unsuitable to participate in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission Rate of Induction Therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-year Overall Survival;1-Year Progression-Free Survival;Recurrence Rate;Mortality Rate; | — |
Countries
China
Contacts
Public ContactZhang Cheng
Medical Center of Hematology, Xinqiao Hospital, Army Medical University, Chongqing, China
Outcome results
None listed