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Venetoclax, Azacitidine, and Mitoxantrone Hydrochloride Liposome Versus Idarubicin and Cytarabine in Newly Diagnosed AML

ConditionAcute Myeloid Leukemia (AML)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe First Affiliated Hospital of Soochow University

About this trial

This study aims to evaluate the efficacy and safety of venetoclax combined with azacitidine and mitoxantrone hydrochloride liposome (MVA) versus idarubicin combined with cytarabine (IA) in the treatment of newly diagnosed AML.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. The patient fully understands the study, voluntarily participates, and has signed the informed consent form (ICF).

Disqualifiers

Acute promyelocytic leukemia (APL);

Central nervous system leukemia (CNSL);

AML secondary to chemotherapy/radiotherapy for other malignancies or antecedent hematological disorders (e.g., MDS, MPN, CML);

Prior treatment with hypomethylating agents (HMA) or venetoclax;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mitoxantrone Hydrochloride Liposome

    Drug

    Mitoxantrone Hydrochloride Liposome: 24 mg/m², administered by intravenous drip (ivgtt) on day 1

  • Venetoclax

    Drug

    Venetoclax: 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3-9, administered orally (po)

  • Azacitidine

    Drug

    Azacitidine: 75 mg/m², administered subcutaneously (sc) on days 1-7

  • Idarubicin

    Drug

    Idarubicin: 12 mg/m², administered by intravenous drip (ivgtt) on days 1-3

  • Cytarabine

    Drug

    Cytarabine: 100 mg/m², administered by intravenous drip (ivgtt) on days 1-7

Treatment groups

204 Participants
are divided into 2 treatment groups
Group A: MVAExperimental treatment 3 interventions
Group B: IAActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Composite Complete Remission(CRc) rate after one cycle of induction therapy

Complete remission plus complete remission with partial hematologic recovery plus complete remission with incomplete hematologic recovery (CR+CRh+CRi). Response is assessed according to the the European LeukemiaNet (ELN) 2022 criteria.

Time frame
At the end of the first treatment cycle (Day 28 ± 7), each cycle is 28 days).

Secondary outcomes

1

Measurable residual disease (MRD) negativity rate (by flow cytometry and molecular testing) among patients who achieved CRc after induction therapy

Percentage of participants who achieve a CRc MRD- as defined by investigators based on ELN 2022 criteria.

Time frame
At the end of each cycle (Day 28 ± 7), each cycle is 28 days, up to 2 cycles.
2

Overall response rate(ORR) to induction therapy

CRc+morphologic leukemia-free state (MLFS)+partial remission (PR). Response is assessed according to the the European LeukemiaNet (ELN) 2022 criteria.

Time frame
At the end of each cycle (Day 28 ± 7), each cycle is 28 days, up to 2 cycles
3

Time to CRc

Defined as the time from day 1 of the treatment until the patient achieves CRc. Response is assessed according to the the European LeukemiaNet (ELN) 2022 criteria.

Time frame
Within 100 days from day 1 of treatment.
4

1-year relapsed-free survival (RFS) rate

Defined only for patients achieving CRc. Measured from the date of achievement of remission until the date of hematologic relapse or death from any cause.

Time frame
up to 1 years after the date of the last enrolled participants

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital of Soochow University

Lead sponsor

CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: