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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04752527
Recruitment Status : Recruiting
First Posted : February 12, 2021
Last Update Posted : November 15, 2021
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital of Soochow University

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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia, Adult Drug: venetoclax combined with decitabine Phase 2

Detailed Description:
The non-elderly AML patients who meet the adverse risk group defined as 2017 European LeukemiaNet (ELN) risk stratification, are more likely to be refractory to intensive induction and have low rates of long-term survival. Venetoclax (drug name) plus decitabine or azacitidine showed tolerable safety and favorable overall response rate (ORR )(complete remission (CR)+CR with incomplete hematologic recovery (CRi) rate: 67%) in elderly AML patients. In addition, combination therapy with sorafenib, cytarabine and idarubicin was able to induce a high CR rate in non-elderly AML patients with FLT3 mutations and a 1-year probability of survival of 74%. The fast next-generation sequencing together with FISH can identify the adverse genetic risk features in AML patients within 72 hours. Individualized induction therapy will be applied to the non-elderly AML patients with adverse genetic risk features guided by rapid screening with FISH and NGS, such as the combination of venetoclax plus decitabine, and Sorafenib for patients with high 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Clinical Study of Individualized Induction Therapy for Non-elderly Patients With Acute Myeloid Leukemia and Adverse Risk Features Guided by Rapid Screening With FISH and NGS
Actual Study Start Date : February 20, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022


Arm Intervention/treatment
Experimental: Treatment regime
combination of venetoclax plus azacitidine, and Sorafenib for patients with high FLT3-ITD allelic ratio
Drug: 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 Name: combination of venetoclax plus decitabine with or without sorafenib




Primary Outcome Measures :
  1. 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 ]
    Complete remission/complete remission with incomplete count recovery/Morphologic Leukemia Free State(after one cycle or two cycles of induction therapy)


Secondary Outcome Measures :
  1. Event Free Survival(EFS) [ Time Frame: Study start date to study end date, or death, whichever comes first, up to 4 years ]
    Event Free Survival

  2. Overall Survival(OS) [ Time Frame: Study start date to study end date, or death, whichever comes first, up to 4 years ]
    Overall Survival

  3. Incidence of Adverse Events [ Time Frame: Study start date to study end date, or death, whichever comes first, up to 4 years ]
    infection, blood transfusion, and other toxicity



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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female, 59 > =Age (years) >= 18;
  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:

  1. Acute promyeloid leukemia;
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04752527


Contacts
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Contact: suning chen, professor 8613814881746 chensuning@sina.com

Locations
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China, Jiangsu
The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology Recruiting
Suzhou, Jiangsu, China, 215000
Contact: Suning Chen    13814881746    chensuning@sina.com   
Sponsors and Collaborators
The First Affiliated Hospital of Soochow University
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Responsible Party: The First Affiliated Hospital of Soochow University
ClinicalTrials.gov Identifier: NCT04752527    
Other Study ID Numbers: SZ-AML01
First Posted: February 12, 2021    Key Record Dates
Last Update Posted: November 15, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Sorafenib
Decitabine
Venetoclax
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites