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

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

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

Treatments tested in this trial

  • Chidamide
  • Azacitidine
  • Venetoclax

Treatment groups

92 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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