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New treatment option for Acute Myeloid Leukemia
Official title VAM in Secondary AML, AML With Extramedullary Involvement, and Myeloid Sarcoma
ClinicalTrials.gov ID: NCT07028086
What this study is testing
What is VAM_GROUP?
VAM_GROUP is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute myeloid leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The mitoxantrone liposomal enhances the tissue permeability of mitoxantrone by incorporating liposomal groups compared to the conventional mitoxantrone formulation, while also reducing the concentration of free mitoxantrone, thereby minimizing drug side effects-particularly cardiotoxicity. Building upon this, the investigators aim to investigate the efficacy and safety of the liposomal mitoxantrone hydrochloride injection in patients with secondary AML, AML with extramedullary involvement, or myeloid sarcoma, in order to explore alternative therapeutic strategies for these populations.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- The patient fully understands this study, voluntarily participates, and signs the informed consent form (ICF)
- Age 18-65 years
- Clinically diagnosed, previously untreated acute myeloid leukemia (non-APL), meeting any one of the following criteria: a. Secondary acute myeloid...
- Normal cardiac function, with left ventricular ejection fraction (LVEF) ≥50%
- Liver and kidney function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal (ULN) (≤5 times...
You likely can't join if
- Assessed as unfit- or frail-AML;
- Patients with a history or concurrent diagnosis of other malignancies requiring treatment
- Uncontrolled systemic diseases (e.g., advanced active infections, uncontrolled hypertension, etc.)
- Known history of immediate or delayed hypersensitivity reactions to the same class of study drugs or excipients
- Pregnant or breastfeeding women, or patients who refuse to use effective contraception during the study period
- Patients with a history of severe neurological or psychiatric disorders
See the full eligibility criteria
- The patient fully understands this study, voluntarily participates, and signs the informed consent form (ICF)
- Age 18-65 years
- Clinically diagnosed, previously untreated acute myeloid leukemia (non-APL), meeting any one of the following criteria: a. Secondary acute myeloid leukemia; b. Therapy-related acute myeloid leukemia; c. AML with...
- Normal cardiac function, with left ventricular ejection fraction (LVEF) ≥50%
- Liver and kidney function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal (ULN) (≤5 times ULN for patients with liver involvement); total bilirubin ≤1.5 times...
- Eastern Cooperative Oncology Group (ECOG) performance status score: 0-2
- Assessed as unfit- or frail-AML;
- Patients with a history or concurrent diagnosis of other malignancies requiring treatment
- Uncontrolled systemic diseases (e.g., advanced active infections, uncontrolled hypertension, etc.)
- Known history of immediate or delayed hypersensitivity reactions to the same class of study drugs or excipients
- Pregnant or breastfeeding women, or patients who refuse to use effective contraception during the study period
- Patients with a history of severe neurological or psychiatric disorders
- Other severe medical conditions, such as myocardial infarction, severe or unstable angina, severe arrhythmias
- Cerebrovascular events (including transient ischemic attacks), etc.
- Known infection with human immunodeficiency virus (HIV); active hepatitis B or C infection; inactive hepatitis carriers or people with low viral titers after receiving non-prohibited antiviral therapy are not excluded
- people who have received strong or moderate CYP3A inducers/inhibitors or strong P-gp inhibitors or related foods within 7 days before starting the study treatment
- Patients unable to take oral medications or with malabsorption syndrome
- Patients deemed by the investigator to be unsuitable for participation in the study
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.