Individualized Induction Therapy for Non-elderly Acute Myeloid Leukemia Patients With Adverse Risk Features

Sponsor
The First Affiliated Hospital of Soochow University
Study ID
NCT04752527
Phase
PHASE2
Status
Unknown

Conditions

  • Acute Myeloid Leukemia, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - 59 Years
Healthy Volunteers
Not accepted

Interventions

  • venetoclax combined with decitabine — DRUG
    combination of venetoclax plus decitabine, and sorafenib for patients with high FLT3-ITD allelic ratio. (On day 1 of cycle 1, decitabine 20 mg/m2 will be given intravenously, and will continue for 5 days. Simultaneously the patient will start out with Venetoclax 100mg and progress to 400mg until the 28 day cycle is finished. For patients with high FLT3-ITD allelic ratio, sorafenib was administered at a dose of 400mg orally twice daily, on days 3 through 28.

Study Details

Individualized induction therapy will be applied to the non-elderly acute myeloid leukemia (AML) patients with adverse genetic risk features guided by rapid screening with fluorescence in situ hybridization (FISH) and next-generation sequencing (NGS), such as the combination of Venetoclax plus decitabine, and Sorafenib for patients with high (FMS)-like tyrosine kinase 3-internal tandem duplication (FLT3-ITD) allelic ratio. This study aims to improve induction therapy for non-elderly AML patients with adverse genetic risk features, reduce treatment-related complications, and improve overall survival.

Key Dates

Start date
Feb 20, 2021
Status verified
Feb 2021
Primary completion
Dec 31, 2021
Completion
Dec 31, 2022

Study Design

Enrollment
42 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment regime
    combination of venetoclax plus azacitidine, and Sorafenib for patients with high FLT3-ITD allelic ratio

Primary Outcome Measure

CR/CRi/morphologic leukemia free state (MLFS) [ Time Frame: Study start date to study end date, or death, whichever comes first, up to 4 years ]

Central Contacts

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