The clinical study of PD-1 inhibitor Tislelizumab combined with HMA+HA/HAG in the treatment of relapsed and refractory AML and elderly AML
Conditions
Interventions
Group 1:HMA combined with Tislelizumab plus low-dose chemotherapy for relapsed and refractory AML
group 2:HMA combined with Tislelizumab plus low-dose chemotherapy for the treatment of early-diagnosed AML
Sponsors
Department of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technol
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Queue 1 admission criteria: 1. Male or non-pregnant non-lactating female patients, aged >= 18 years; 2. AML diagnosed according to the 2016 WHO AML diagnostic criteria (Annex 1, Annex 2) Patients (except M3 type and BCR-ABL positive AML); 3. Patients with relapsed/refractory AML are defined as meeting one of the following conditions: (1) Newly treated cases undergo standard induction chemotherapy and 2 courses of treatment have not achieved complete remission (CR); (2) Those who have undergone consolidation or intensive treatment after reaching CR and have relapsed within 12 months (relapse is defined as: recurrence of leukemia cells in peripheral blood or blast cells in bone marrow> 5% after reaching CR, and the above manifestations have been excluded after consolidation chemotherapy Other reasons such as bone marrow regeneration); (3) Relapse after 12 months of consolidation or intensive treatment after reaching CR, but not reaching CR after being induced by standard protocols; (4) Those who have accumulated 2 or more relapses; 4. Expected survival period >= 3 months; 5. The subject's white blood cell (WBC) count before enrollment must be = 50%; 7. Renal function: serum creatinine (Creatinine, Cr) 60 years old, no gender limit; 2. Newly diagnosed primary AML or secondary AML that meets the WHO diagnostic criteria (primitive cells in bone marrow or peripheral blood >=20%; or primordial cells = 3 months; 5. The subject's white blood cell count = 50%; 7. Serum creatinine value <= 2 x ULN; 8. Serum bilirubin value <= 2 x ULN, or serum bilirubin value <= 3 x ULN (if it is caused by leukemia or Gilbert syndrome); 9. Serum transaminase <= 2.5 x ULN, or serum transaminase <= 5 x ULN (if elevated transaminase is considered to be caused by leukemia infiltration); 10. Effective contraception/avoidance measures should be taken throughout the treatment period and 6 months after the treatment period; 11. Sign a wr
Exclusion criteria
Exclusion criteria: 1. APL; 2. Received anti-tumor biologic drug therapy (such as monoclonal antibody) within 12 weeks before the first administration; 3. There are active, known or suspected autoimmune diseases; 4. Women during pregnancy and lactation; 5. Past history of solid organ transplantation; 6. Symptomatic central nervous system leukemia; 7. Severe interstitial lung disease or active pneumonia; 8. There are other major diseases or infections that are not clinically controllable; 9. Known history of systemic autoimmune diseases; 10. Uncontrolled concurrent diseases, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone marrow cytology; | — |
Countries
China
Contacts
Public ContactHong Mei
Union Hospital, Tongji Medical College of HUST
Outcome results
None listed