Clinical Study Protocol for the Treatment of ND-AML and RR-AML With KMT2A Gene Abnormalities Using VHEA.
Key facts
- Where
- Huai'an, KínaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Where in Kína
- The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University#Huai'an First People's Hospital#Huai'an, KínaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Huai'an First People's Hospital
- Trial code
- NCT06328179
- Record updated
- 2024. március 25.
- Original description
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.Read full original descriptionShow less
Clinical Study Protocol for the Treatment of Newly Diagnosed and Relapsed/Refractory Acute Myeloid Leukemia With KMT2A Gene Abnormalities Using VHEA（Venetoclax With Homoharringtonine，Etoposide，Cytarabine）
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.
Inclusion: 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: 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; Participation in any other clinical study within 3 months prior to signing the informed consent; Presence of other malignancies; Uncontrolled active infection (including bacterial, fungal, or viral infection) and visceral bleeding; Any other condition deemed unsuitable for participation in this study by the investigator; Pregnant or lactating women.