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

RECRUITINGPhase 2Sponsored by Chinese PLA General Hospital
Actively Recruiting
PhasePhase 2
SponsorChinese PLA General Hospital
Started2023-08-01
Est. completion2029-01-31
Eligibility
Age14 Years – 75 Years
Healthy vol.Accepted

Summary

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.

Eligibility

Age: 14 Years – 75 YearsHealthy volunteers accepted
Inclusion Criteria:

* 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 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.)

Conditions2

CancerRelapsed/Refractory Acute Myeloid Leukemia

Interventions1

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