The Maintenance Treatment of "ITIVA" in AML Patients (NCT06256627) | Clinical Trial Compass
RecruitingNot Applicable
The Maintenance Treatment of "ITIVA" in AML Patients
China130 participantsStarted 2023-07-11
Plain-language summary
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.
Who can participate
Age range14 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. Have a history of APL.
What they're measuring
1
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
✕. 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.
✕. There is a history of AML active central nervous system involvement.
✕. HIV infected patients.
✕. Uncontrolled infection.
✕. Merge New York Heart Association\>Level 2 Cardiovascular Dysfunction Status. Level 2 is defined as heart disease where the subject feels comfortable during rest, but regular physical activity can lead to fatigue, palpitations, breathing difficulties, or angina.