NCT05177731

Venetoclax + Decitabine vs. "7+3" Induction Chemotherapy in Young AML

Comparing the Efficacy and Safety of Venetoclax Combined With Decitabine Versus Conventional "7+3" Induction Chemotherapy of Acute Myeloid Leukemia in Young Adults

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 188 (actual)
• Sponsor: Chen Suning · Academic / Other
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Not accepted

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)

Detailed description

This is an open-label, multicenter, phase 2 randomized clinical trial to compare the therapeutic efficacy and safety of venetoclax and decitabine to the conventional induction chemotherapy (7+3 regimen) 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 consolidation 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.

Conditions

• AML, Adult
• Chemotherapy Effect

Interventions

Type	Name	Description
DRUG	Venetoclax	Orally by mouth
DRUG	Decitabine for Injection	Intravenous infusion
DRUG	Cytarabine	Intravenous infusion
DRUG	Idarubicin	Intravenous infusion
DRUG	Gilteritinib	Orally by mouth

Timeline

• Start date: 2022-03-01
• Primary completion: 2024-02-28
• Completion: 2024-12-31
• First posted: 2022-01-05
• Last updated: 2024-10-03

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study