OncoMatch/Clinical Trials/NCT05183035
Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)
Is NCT05183035 recruiting? Yes, currently enrolling (Sep 2026). This Phase 3 trial studies multiple treatments for acute myeloid leukemia.
Treatment: Fludarabine · Cytarabine · Gemtuzumab Ozogamicin · Azacitidine · Venetoclax — A study to evaluate if the randomized addition of venetoclax to a chemotherapy backbone (fludarabine/cytarabine/gemtuzumab ozogamicin \[GO\]) improves survival of children/adolescents/young adults with acute myeloid leukemia (AML) in 1st relapse who are unable to receive additional anthracyclines, or in 2nd relapse.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: FLT3 wild-type
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Lab requirements
Kidney function
Creatinine clearance or GFR ≥ 60ml/min/1.73 m^2, or normal serum creatinine based on age/sex
Liver function
Direct bilirubin < 1.5 x ULN; alkaline phosphatase ≤ 2.5 x ULN; ALT ≤ 2.5 x ULN (up to 5x ULN if due to leukemia infiltrate or steatosis)
Cardiac function
No history of congestive heart failure in need of medical treatment; no pre-treatment diminished left ventricular function (SF < 25% or EF < 40%); no signs of congestive heart failure at presentation of relapse
Adequate organ function: renal, hepatic, cardiac as defined in protocol
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Phoenix Children's Hospital · Phoenix, Arizona
- Arkansas Children's Hospital · Little Rock, Arkansas
- MemorialCare Miller Children's and Women's Hospital Long Beach · Long Beach, California
- Children's Hospital of Orange County Main Campus - Orange · Orange, California
- Benioff Children's Hospital - Mission Bay · San Francisco, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05183035 currently recruiting?
Yes, this trial is currently recruiting patients.
Does this trial require FLT3?
Yes, FLT3 wild-type is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 21 years or younger and at least 0 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages