Clinical Study Protocol for the Treatment of ND-AML and RR-AML With KMT2A Gene Abnormalities Using VHEA.
About this study
This study is a clinical trial aimed at evaluating the efficacy and safety of the VHEA（Venetoclax with Homoharringtonine，Etoposide，Cytarabine）regimen in the treatment of newly diagnosed and relapsed/refractory acute myeloid leukemia (AML) with MLL gene abnormalities. This study includes the induction and consolidation phases of AML treatment.
- Condition
- Acute Myeloid Leukemia
- Tested
- Venetoclax 100 mg d1，200 mg d2，400 mg d3-14；
- Sponsor
- Huai'an First People's Hospital
Who can join
- Age
- 18 to 60 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 8
- Minimum age: 18 years
- Maximum age: 60 years
- Study condition: Acute Myeloid Leukemia
- Age between 18 and 60 years old;Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Expected survival time of at least 3 months.
- Does not meet any of the following criteria for severe heart, lung, liver, or kidney disease:A) History of congestive heart failure requiring treatment, or ejection fraction ≤ 50%, or presence of chronic stable angina;B) Lung diffusing capacity for carbon monoxide (DLCO) ≤ 65%, or forced expiratory volume in one second (FEV1) ≤ 65%;C) Moderate liver dysfunction, total bilirubin \> 1.5 to ≤ 3.0 × upper limit of normal (ULN);D) Creatinine clearance ≥ 30 mL/min to \< 45 mL/min.
- No other significant contraindications to chemotherapy as determined by the physician;
- Capable of understanding and willing to sign the informed consent form for this study.
Exclusion 6
- Presence of other malignancies;
- Underwent cardiac vascular intervention or stent placement within 12 months prior to signing the informed consent, or history of myocardial infarction, unstable angina, or other clinically significant cardiac disease;
- Uncontrolled active infection (including bacterial, fungal, or viral infection) and visceral bleeding;
- Pregnant or lactating women;
- Participation in any other clinical study within 3 months prior to signing the informed consent;
- Any other condition deemed unsuitable for participation in this study by the investigator.
Where
1 site, 1 recruiting
The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University（Huai'an First People's Hospital）
Huai'an, Jiangsu, China
Contact
-
Shandong Tao
15252393900 TSD8884@126.com
Potential match only. Final eligibility is determined by the study team.