The Maintenance Treatment of "ITIVA" in AML Patients
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.
Timeline
- Start
- 2023-07-11
- Primary completion
- 2025-03-01
- Completion
- 2027-05-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Azacitidine | Other / unclassified | — | — |
| Comparator | Thalidomide | Other / unclassified | — | — |
| Comparator | Venentoclax | Unknown | — | — |
| Comparator | aldesleukin | Protein / enzyme biologic | — | — |
| Comparator | recombinant human interference'- α- 1b, interleukin-2, thalidomide, Venentoclax and Azacitidine | Protein / enzyme biologic | — | — |