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.
Have a history of APL.
Morphologically recurrent or refractory AML patients.
Previous history of prodromal hematological diseases or treatment-related AML.
MRD positive patients are scheduled to undergo allogeneic hematopoietic stem cell transplantation within one month. Patients with negative MRD are scheduled to undergo allogeneic hematopoietic stem cell transplantation within 6 months. Patients who have previously received allogeneic hematopoietic stem cell transplantation.
Parallel
recombinant human interference'- α- 1b, interleukin-2, thalidomide, Venentoclax and Azacitidine
DrugPatients in arm1 were randomly divided into two groups, namely the " interference'- α- 1b, interleukin-2, thalidomide" treatment group and the "VA" treatment group. After receiving a two cycle protocol, patients were evaluated for the endpoint of the trial and their MRD conversion rate was calculated. Patients in arm2 will receive triple maintenance treatment, completing three alternative regimens into one cycle. The regimen maintenance treatment will be maintained for a total of 8 cycles. Each medication regimen takes 28 days as a cycle. The number of days administered per cycle can be adjusted based on the patient's blood count.
the negative MRD conversion rate of AML patients and whether the combination of triple maintenance treatment can improve relapse free survival (RFS) in AML patients
To evaluate the negative MRD conversion rate of AML patients after "interference'- α- 1b, interleukin-2, and thalidomide" treatment and whether triple maintenance treatment can improve relapse free survival (RFS) in AML patients who have achieved CR or CRi through conventional induction and consolidation chemotherapy
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