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Clinical Study of Venetoclax Combined With CACAG Regimen in the Treatment of Newly Diagnosed Acute Myeloid Leukemia

Clinical Study of Venetoclax Combined With CACAG Regimen in the Treatment of Newly Diagnosed Acute Myeloid Leukemia

Recruiting
14-75 years
All
Phase 2

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Overview

The purpose of this study is to compare the efficacy and safety of venetoclax combined with CACAG regimen with the traditional "3+7" regimen in the treatment of newly diagnosed acute myeloid leukemia.

Description

Despite the availability of hematopoietic stem cell transplantation and the emergence of many new therapeutic drugs, the prognosis of newly diagnosed acute myeloid leukemia is still poor.Over the past years, combination chemotherapy with anthracycline and standard dose cytarabine (standard "3+7" induction therapy) remains the standard induction. In order to improve the outcome of patients with de novo AML, we developed a venetoclax combined with CACAG regimen in the treatment of de novo AML. In this study, we intent to compare the efficacy and safety of venetoclax combined with CACAG regimen with the traditional "3+7" regimen in the treatment of newly diagnosed acute myeloid leukemia.

Eligibility

Inclusion Criteria:

Patients who are able to understand and willing to sign the informed consent form (ICF).

  • All patients should aged 14 to75 years,no gender limitation.
  • Patients who are newly diagnosed with AML(no M3).
  • Liver function: ALT and AST≤2.5 times the upper limit of normal ,bilirubin≤2 times the upper limit of normal;
  • Renal function: creatinine ≤the upper limit of normal;
  • Patients without any uncontrolled infections , without organ dysfunction or without severe mental illness;
  • The score of Eastern Cooperative Oncology Group (ECOG) is 0-3,and the predicted survival ≥ 4 months.
  • Patients without severe allergic constitution.

Exclusion Criteria:

  • Patients with allergy or contraindication to the study drug;
  • Female patients who are pregnant or breast-feeding.
  • Patients with a known history of alcohol or drug addiction on the basis that there could be a higher risk of non-compliance to study treatment;
  • Patients with mental illness or other states unable to comply with the protocol;
  • Less than 6 weeks after surgical operation of important organs.
  • Liver function: ALT and AST>2.5 times the upper limit of normal ,bilirubin> 2 times the upper limit of normal;Renal function: creatinine >the upper limit of normal;
  • The patient is not suitable for this clinical trial (poor compliance, substance abuse, etc.)

Study details
    Acute Myeloid Leukemia

NCT06068621

Chinese PLA General Hospital

26 January 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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