Individualized Induction Therapy for Non-elderly Acute Myeloid Leukemia Patients With Adverse Risk Features
NCT ID: NCT04752527
Last Updated: 2021-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
42 participants
INTERVENTIONAL
2021-02-20
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment regime
combination of venetoclax plus azacitidine, and Sorafenib for patients with high FLT3-ITD allelic ratio
venetoclax combined with decitabine
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.
Interventions
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venetoclax combined with decitabine
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Newly diagnosed as AML patients according to World Health Organization (WHO) classification;
3. AML patients meet the adverse risk group according to 2017 European Leukemia Net risk stratification;
4. Patients have not received prior therapy for AML (except HU);
5. Eastern Cooperative Oncology Group (ECOG) Performance status of 0,1, 2 ;
6. 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)
7. Renal function：Ccr ≧30 ml/min;
8. 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.
Exclusion Criteria
2. AML with central nervous system (CNS) infiltration；
3. Patients have received prior hypomethylating agents (HMA) therapy for myelodysplastic syndrome (MDS) and progressed to AML；
4. HIV infection;
5. Patients with severe heart failure (grade 3-4) ;
6. 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
7. Patients deemed unsuitable for enrolment by the investigator;
8. Patients willing to receive intensive induction chemotherapy
9. Female who are pregnant, breast feeding or childbearing potential without a negative urine pregnancy test at screen；
10. Patients reject to participate in the study.
18 Years
59 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Soochow University
OTHER
Responsible Party
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Locations
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The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
Suzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Suning Chen
Role: primary
Other Identifiers
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SZ-AML01
Identifier Type: -
Identifier Source: org_study_id