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NCT Number: NCT06470841

CHG Combined With Venetoclax and Azacytidine in Newly Diagnosed AML

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.

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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CHG Combined With Venetoclax and Azacytidine

Drug

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.

Other names: VACHG

Primary outcomes

  1. Overall Response Rate (ORR)

    Time frame: 1 year

    ORR was defined as the proportion of patients who achieved CR or PR as their best response

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: through study completion, an average of 3 years

    OS was defined as time from diagnosis to death from any cause or the last follow-up

  2. Progression Free Survival (PFS)

    Time frame: 2 years

    For patients in morphologic remission, documented relapse was considered progression. Relapse following complete remission(CR) is defined as reappearance of leukemic blasts in the peripheral blood or the finding of more than 5% blasts in the BM, not attributable to another cause (eg, BM regeneration after consolidation therapy) or extramedullary relapse.

Study contacts

Contact information is provided by the study sponsor or research team.

Liren Qian, PhD

CONTACT

[email protected]

+861066947192

Sponsors and collaborators

Lead sponsor

Navy General Hospital, Beijing

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jun 24, 2024
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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