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Not yet recruiting NCT06470841

CHG Combined With Venetoclax and Azacytidine in Newly Diagnosed AML

Phase II Interventional Acute Myeloid Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CHG Combined With Venetoclax and Azacytidine.
Who it may be relevant to
Registry conditions: Acute Myeloid Leukemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

CHG Regimen Combined With Venetoclax and Azacytidine in Newly Diagnosed Acute Myeloid Leukemia

Overview

The goal of this phase 2 trial is to test the safety and efficacy of CHG Combined With Venetoclax in treating patients with newly diagnosed AML.

Detailed description

The investigators will evaluate response rate of CHG regimen Combined With Venetoclax in newly diagnosed acute myeloid leukemia. After induction therapy, patients will be given standardized treatment according to risk stratification according to NCCN guidelines. Progression free survival (PFS), Overall survival (OS), and Toxicity will be counted.

Interventions

  • Drug CHG Combined With Venetoclax and Azacytidine
    Patients were treated by CHG Combined With Venetoclax and Azacytidine: Venetoclax 100mg po qd d1, 200mg po qd d2, 400mg po qd d3-14; Azacytidine 75 mg/m2 subcutaneous injection qd d1-7; Homoharringtonine 1mg/m2 iv qd d1-14; Cytarabine 10mg/m2 subcutaneous injection q12h d1-14; G 250ug/m2 subcutaneous injection qd d0-14.

Primary outcome measures

  • Overall Response Rate (ORR) [Time frame: 1 year]
Secondary outcome measures (2)
  • Overall Survival (OS) [Time frame: through study completion, an average of 3 years]
  • Progression Free Survival (PFS) [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

  • The patient should, in the investigator's opinion, be able to meet all clinical trial requirements.
  • The patient is willing and able to adhere to the study visit schedule and other protocol requirements.
  • The patient should be diagnosed with AML according to the standard criteria of the World Health Organisation (WHO).
  • The patient should not have received any prior treatment for AML.

Exclusion criteria

  • Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment.
  • Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy.
  • Pregnant or lactating women.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Navy General Hospital — Beijing

Identifiers

NCT: NCT06470841 · WATCH2023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗