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Recruiting Phase 2

Clinical Study of Venetoclax Combined With CACAG Regimen in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia

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About this study

The purpose of this study is to compare the efficacy and safety of venetoclax combined with CACAG regimen with BAT regimen in the treatment of relapsed/refractory acute myeloid leukemia.

Condition
Relapsed/Refractory Acute Myeloid Leukemia
Tested
Azacytidine;Cytarabine;Aclacinomycin;Chidamide;Venetoclax;Granulocyte colony-stimulating factor, Best-Available Therapy(...
Sponsor
Chinese PLA General Hospital

Who can join

Age
14 to 75 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 11

  • Minimum age: 14 years
  • Maximum age: 75 years
  • Study condition: Relapsed/Refractory Acute Myeloid Leukemia
  • Patients who are able to understand and willing to sign the informed consent form (ICF).
  • All patients should aged 14 to 75 years,no gender limitation.
  • Patients with R/R AML, diagnosed in accordance with the 2021 edition of the CMA criteria
  • 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 7

  • 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.)

Where

1 site, 1 recruiting

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.