A Multicenter, Single Arm Clinical Study on the Efficacy and Safety of the ITIVA Protocol in Patients With Complete Remission of AML at Initial Diagnosis
We apply for this clinical study to evaluate the efficacy of combined recombinant human interference'- α- 1b, interleukin-2, and thalidomide regimen in obtaining MRD positive AML patients in CR,as well as the efficacy of the Venentoclax and azacitidine regimen and the combined recombinant human interference'- α- 1b, interleukin-2, and thalidomide regimen in alternately maintaining the treatment of MRD negative AML patients. The study included two cohorts. The first cohort consisted of AML patients who obtained CR or CRi but MRD positive after induction chemotherapy and consolidation chemotherapy. They were randomly given two cycles of recombinant human interference'- α- 1b, interleukin-2, and thalidomide or VA regimen treatment, and the MRD conversion rates of the two groups were analyzed. In the second cohort , after induction chemotherapy and consolidation chemotherapy, AML patients with CR or CRi and negative MRD were obtained, and were given recombinant human interference'- α- 1b, interleukin-2, and thalidomide, Venentoclax and Azacitidine triple alternative maintenance treatment, to analyze the impact of maintenance treatment scheme on long-term survival of aml patients.
• Male or female, ≥ 14 years old.
• According to the WHO (2016) diagnostic criteria, the diagnosis of newly diagnosed AML is met (excluding APL).
• After conventional induction and chemotherapy with at least two consolidation schemes (at least one cycle of the scheme containing medium dose or above of Cytarabine, or the scheme of vinecla combined with Azacitidine gets remission, and continues to use the scheme to consolidate at least 6-8 cycles), CR or CRI can be achieved.
• \<6 months from the last chemotherapy.
• Having sufficient organ functions: creatinine clearance rate ≥ 30 mL/min; Bilirubin\<3.0 × Upper limit of normal value (ULN) (sufficient liver function level); Platelets ≥ 50 × 10\^9/L; Neutrophil count ≥ 1 × 10\^9/L in granulocyte stimulated hematopoietic therapy
• Whole body functional state score (ECOG) 0-2 points
• The subjects are willing and able to follow the process required by this protocol.