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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    188
  • sponsor
    Chen Suning
Updated on 13 March 2022

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)

Description

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

Details
Condition AML, Adult, Chemotherapy Effect
Treatment cytarabine, Idarubicin, venetoclax, Decitabine for Injection
Clinical Study IdentifierNCT05177731
SponsorChen Suning
Last Modified on13 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female, 59 > =Age (years) >= 18
Newly diagnosed as AML patients according to World Health Organization (WHO) classification
Patients have not received prior therapy for AML (except hydroxyurea and Ara-C<1.0g/d)
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(Creatinine Clearance Rate) ≧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

Exclusion Criteria

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
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
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