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Venetoclax and Azacitidine Combined With Chidamide (VAC) for the Treatment of Newly Diagnosed Acute Monocytic Leukemia

ConditionsAcute Monocytic LeukemiaNewly Diagnosed
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Soochow University

About this trial

This study is to investigate the therapeutic efficacy and side effect of venetoclax, azacytidine combined with chidamide for newly diagnosed acute monocytic leukemia patients that are ineligible for intensive chemotherapy

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

>= 60 years of age

Must meet the laboratory requirements per the protocol.

Female participant must not be pregnant or breastfeeding and is not considering becoming pregnant or donating eggs during the study or for approximately 90 days after the last dose of study drug.

Female participants of childbearing potential must agree to use at least 1 protocol-specified method of birth control and male participants, if sexually active with female partner(s) of childbearing potential, must agree to practice the protocol-specified contraception.

Disqualifiers

Patients who are allergic to the study drug or drugs with similar chemical structures

Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception

Active infection

Active bleeding

Trial design

Design model

Parallel

Treatments tested in this trial

  • Chidamide

    Drug

    Chidamide 10mg orally daily for 7 days (d1-d7)

  • Azacitidine

    Drug

    azacytidine 75mg/m2 daily for 7 days (d1-d7)

  • Venetoclax

    Drug

    Venetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-28)

Treatment groups

92 Participants
are divided into 2 treatment groups
Group A: VAC groupExperimental treatment 3 interventions
Group B: VA groupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Composite Complete Remission Rate

The composite complete remission rate(complete remission plus complete remission with incomplete blood cell count recovery)

Time frame
At the end of Cycle 1 or 2 (each cycle is 28 days)
2

Overall response rate (ORR)

The overall response (completed remission without minimal residual disease, completed remission with incomplete blood count recovery, morphologic leukemia-free state and partial remission)

Time frame
At the end of Cycle 1 or 2 (each cycle is 28 days)

Secondary outcomes

1

Duration of Response (DOR)

It is measured the time from initial response to subsequent disease progression or relapse

Time frame
1 year
2

Overall Survival (OS)

It is measured from the time of entry into this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive

Time frame
1 year
3

Progression-Free Survival (PFS)

It is measured from the time from randomization to progression or death

Time frame
1 year
4

Adverse reactions in hematology

Record of adverse events in hematological system during and after VEN+AZA+Chidamide regimen induction (agranulocytosis days, PLT/RBC transfusion units)

Time frame
At the end of Cycle 1 (each cycle is 28 days)

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

Jining Medical University

Collaborator

The Second People's Hospital of Huai'an

Collaborator

The First Affiliated Hospital of Bengbu Medical University

Collaborator

Northern Jiangsu People's Hospital

Collaborator

Affiliated Hospital of Nantong University

Collaborator

Suzhou Hospital of Traditional Chinese Medicine

Collaborator

Taizhou University

Collaborator

Source ClinicalTrials.gov
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