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

NCT04752527 | Unknown Phase 2

• 1 other identifier: SZ-AML01
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Myeloid Leukemia, Adult

Outcome Measures

Primary Outcomes (1)

• CR/CRi/morphologic leukemia free state (MLFS)

  Complete remission/complete remission with incomplete count recovery/Morphologic Leukemia Free State（after one cycle or two cycles of induction therapy）

  Study start date to study end date, or death, whichever comes first, up to 4 years

Secondary Outcomes (3)

• Event Free Survival(EFS)

  Study start date to study end date, or death, whichever comes first, up to 4 years

• Overall Survival(OS)

  Study start date to study end date, or death, whichever comes first, up to 4 years

• Incidence of Adverse Events

  Study start date to study end date, or death, whichever comes first, up to 4 years

Study Arms (1)

Treatment regime

EXPERIMENTAL

combination of venetoclax plus azacitidine, and Sorafenib for patients with high FLT3-ITD allelic ratio

Drug: venetoclax combined with decitabine

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.

Also known as: combination of venetoclax plus decitabine with or without sorafenib

Treatment regime

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female, 59 \> =Age (years) \>= 18;
• Newly diagnosed as AML patients according to World Health Organization (WHO) classification;
• AML patients meet the adverse risk group according to 2017 European Leukemia Net risk stratification;
• Patients have not received prior therapy for AML (except HU);
• Eastern Cooperative Oncology Group (ECOG) Performance status of 0,1, 2 ;
• Liver function: Total bilirubin ≦3 upper limit of normal (ULN); aspartate aminotransferase (AST) ≦3 ULN; alanine aminotransferase (ALT)≦3 ULN(except extramedullary infiltration of leukemia)
• Renal function：Ccr ≧30 ml/min;
• Patients who sign the informed consent must have the ability to understand and be willing to participate in the study and sign the informed consent.

You may not qualify if:

• Acute promyeloid leukemia；
• AML with central nervous system (CNS) infiltration；
• Patients have received prior hypomethylating agents (HMA) therapy for myelodysplastic syndrome (MDS) and progressed to AML；
• HIV infection;
• Patients with severe heart failure (grade 3-4) ;
• Evidence of other clinically significant uncontrolled condition(s) including, but not limited to: a) Uncontrolled and/or active systemic infection (viral, bacterial or fungal); b) Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. c)An active second cancer that requires treatment within 6 months of study entry
• Patients deemed unsuitable for enrolment by the investigator;
• Patients willing to receive intensive induction chemotherapy
• Female who are pregnant, breast feeding or childbearing potential without a negative urine pregnancy test at screen；
• Patients reject to participate in the study.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology

Suzhou, Jiangsu, 215000, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Decitabine; Sorafenib

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Phenylurea Compounds; Urea; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Pyridines

Central Study Contacts

suning chen, professor

CONTACT

8613814881746; chensuning@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 12, 2021
• Study Start: February 20, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: November 15, 2021

Record last verified: 2021-02

Locations

CN (1)