NCT06328179Recruiting
Clinical Study Protocol for the Treatment of ND-AML and RR-AML With KMT2A Gene Abnormalities Using VHEA.
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）
Source: ClinicalTrials.gov · Last updated 25 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 34 (estimated)
- First submitted
- 18 Mar 2024
- Start date
- 24 May 2022
- Primary completion date
- 30 Dec 2027
- Lead sponsor
- Huai'an First People's Hospital
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT06328179
What you commit to
- Study type: Interventional
- Planned participants: 34
- From 24 May 2022 to the primary completion date, 30 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- 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.
Other
- Pregnant or lactating women;
Who the study is looking for
- 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.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University#Huai'an First People's Hospital# Coordinator of this site? Confirm its status | Huai'an | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.