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New treatment option for AML, Adult
Official title Comparison of VA and D/IA Induction Regimens in Elderly Fit Acute Myeloid Leukemia Patients
ClinicalTrials.gov ID: NCT07132684
What this study is testing
What is Daunorubicin/Idarubicin?
Daunorubicin/Idarubicin is an investigational medicine, being studied as a potential treatment for aml, adult.
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
- This study is a multicenter, randomized, controlled phase III clinical trial aimed at comparing the efficacy of two induction chemotherapy regimens-VA (Venetoclax + Azacitidine) and D/IA (Daunorubicin/Idarubicin + Cytarabine)-in elderly patients (aged 55-75) with acute myeloid leukemia (AML) who are fit for intensive chemotherapy.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 to 75
You may be able to join if
- Diagnosis of AML according to WHO (2022) or ICC criteria.
- Age ≥55 and ≤75 years.
- ECOG performance status score of 0-2.
- Adequate organ function:
- Total bilirubin ≤1.5× upper limit of normal (ULN)
You likely can't join if
- Acute promyelocytic leukemia with PML-RARA fusion gene.
- AML with RUNX1-RUNX1T1 or CBFB-MYH11 fusion genes.
- AML with BCR-ABL fusion gene.
- Relapsed or refractory AML (previously treated with induction chemotherapy, but hydroxyurea is allowed).
- Concurrent other malignancies requiring treatment.
- Active cardiac disease (e.g., uncontrolled angina, recent myocardial infarction, severe arrhythmias, uncontrolled heart failure, LVEF below normal).
See the full eligibility criteria
- Diagnosis of AML according to WHO (2022) or ICC criteria.
- Age ≥55 and ≤75 years.
- ECOG performance status score of 0-2.
- Adequate organ function:
- Total bilirubin ≤1.5× upper limit of normal (ULN)
- AST and ALT ≤2.5× ULN
- Serum creatinine \<2× ULN
- Cardiac enzymes \<2× ULN
- Left ventricular ejection fraction (LVEF, by echocardiogram) within normal range Signed informed consent by the patient or legal representative.
- Acute promyelocytic leukemia with PML-RARA fusion gene.
- AML with RUNX1-RUNX1T1 or CBFB-MYH11 fusion genes.
- AML with BCR-ABL fusion gene.
- Relapsed or refractory AML (previously treated with induction chemotherapy, but hydroxyurea is allowed).
- Concurrent other malignancies requiring treatment.
- Active cardiac disease (e.g., uncontrolled angina, recent myocardial infarction, severe arrhythmias, uncontrolled heart failure, LVEF below normal).
- Severe infectious diseases (e.g., untreated tuberculosis, pulmonary aspergillosis).
- Other conditions deemed unsuitable by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, 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, 55 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, 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.