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Clinical Trial Summary

This research is being done to assess the therapeutic efficacy and safety of a promising (venetoclax and decitabine) versus conventional "7+3"chemotherapy in induction young patients with acute myeloid leukemia. This study involves the following: Venetoclax and decitabine (investigational combination) Cytarabine and idarubicin (per standard of care)


Clinical Trial Description

This is an open-label, multicenter, phase Ⅲ randomized clinical trial to compare the therapeutic efficacy and safety of conventional induction chemotherapy (7+3 regimen) to the combination of venetoclax and decitabine among fit, young adults with newly diagnosed acute myeloid leukemia (AML). Conventional induction chemotherapy with idarubicin and cytarabine is the standard of induction chemotherapy for acute myeloid leukemia (AML). The FDA has approved the combination therapy of venetoclax and decitabine for elderly (> 60 year old) patients with newly diagnosed AML not eligible for intensive chemotherapy. Venetoclax is an inhibitor of BCL-2 (B-cell lymphoma 2, a protein that initiates tumor growth, disease progression, and drug resistance), which can lead to cancer cell death. Decitabine, a demethylation agent, has the potential to synergically target leukemia stem cell populations when combined with venetoclax as its homologous drug azacytidine. Participants will be randomly assigned to one of the different induction groups and followed with either consolidated chemotherapy or allogeneic hematopoietic stem cell transplantation after remission. After completion of study treatment, participants are followed up every 3 to 6 months for up to 2 years. It is expected that about 188 people will take part in this research study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05177731
Study type Interventional
Source The First Affiliated Hospital of Soochow University
Contact Suning Chen
Phone +86-13814881746
Email [email protected]
Status Recruiting
Phase Phase 3
Start date January 1, 2022
Completion date December 31, 2024

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