Comparison of VA and D/IA Induction Regimens in Elderly Fit Acute Myeloid Leukemia Patients
Recruiting
Phase 3
Interventional Study
AML, Adult
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 55 – 75
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 240 (estimated)
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China · Other
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About This Trial
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.
Trial Locations
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Eligibility Criteria
Inclusion 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 enzy…
Contacts