Trial studying safety and effects for AML (Acute Myelogenous Leukemia)
Official title Efficacy of Venetoclax Combined With Intensive Chemotherapy in Different Subgroups of AML
ClinicalTrials.gov ID: NCT06635681
What this study is testing
What is Daunorubicin?
Daunorubicin is an investigational medicine, being studied as a potential treatment for aml (acute myelogenous 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
- Acute myeloid leukemia (AML) is a common hematological malignancy.
- 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 14 to 60
You may be able to join if
- Patients who meet AML according to WHO (2022) or AML and MDS/AML defined by ICC standards.
- Age ≥14 years old, ≤ 60 years old, male or female.
- The physical status assessment (ECOG-PS) of the Eastern Oncology Collaboration group was 0-2 points.
- Total bilirubin ≤ 1.5 times the upper limit of normal value (same age);
- AST and ALT≤ 2.5 times the upper limit of normal value (same age);
You likely can't join if
- Acute promyelocytic leukemia with PML-RARA fusion gene
- Acute myeloid leukemia with BCR-ABL fusion gene
- Treated patients (but can receive hydroxyurea or cytarabine to the lower tumor burden).
- Concurrent malignant tumors of other organs (those requiring treatment).
- A history of uncontrolled or symptomatic angina;
- Myocardial infarction less than 6 months after enrollment;
See the full eligibility criteria
- Patients who meet AML according to WHO (2022) or AML and MDS/AML defined by ICC standards.
- Age ≥14 years old, ≤ 60 years old, male or female.
- The physical status assessment (ECOG-PS) of the Eastern Oncology Collaboration group was 0-2 points.
- Total bilirubin ≤ 1.5 times the upper limit of normal value (same age);
- AST and ALT≤ 2.5 times the upper limit of normal value (same age);
- Blood creatinine \< 2 times the upper limit of normal (same age);
- Myocardial enzymes \< 2 times the upper limit of normal (same age);
- Left ventricular ejection fraction \>50% by measure of echocardiogram (ECHO). Informed consent must be signed before the commencement of all specific study procedures, and signed by the patient himself or his immediate...
- Acute promyelocytic leukemia with PML-RARA fusion gene
- Acute myeloid leukemia with BCR-ABL fusion gene
- Treated patients (but can receive hydroxyurea or cytarabine to the lower tumor burden).
- Concurrent malignant tumors of other organs (those requiring treatment).
- A history of uncontrolled or symptomatic angina;
- Myocardial infarction less than 6 months after enrollment;
- Have a history of arrhythmia requiring drug treatment or severe clinical symptoms;
- Uncontrolled or symptomatic congestive heart failure (\> NYHA level 2);
- Serious infectious diseases (uncured tuberculosis, pulmonary aspergillosis).
- Those who were not considered suitable for inclusion by the researchers.
The study team makes the final eligibility decision.
Where it is enrolling
- Tianjin, Tianjin Municipality, 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, but 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, 14 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.