NCT05183035 · PedAL BCU, LLC
Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)
What this study is about
A study to evaluate if the randomly assigned 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.
View original scientific description
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.
Interventions
DRUG
Fludarabine
Intravenous (IV) infusion
DRUG
Cytarabine
Intravenous (IV) infusion
DRUG
Gemtuzumab Ozogamicin
Intravenous (IV) infusion
DRUG
Azacitidine
Intravenous (IV) infusion or subcutaneous injection
DRUG
Venetoclax
Orally via tablet or powder suspension
Primary outcome measures
Overall Survival (OS)
Time frame: Up to 5 years
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Participants must have enrolled on APAL2020SC, NCT Number: NCT04726241 prior to enrollment on ITCC-101/APAL2020D. (This is only applicable for participants in USA/Canada/Australia/New Zealand sites/LLS territory).
- Participants must be ≥ 29 days of age and ≤ 21 years of age at enrollment.
- Participants must have one of the following: 1. Children, adolescents, and young adults with AML without demonstrated FLT3/internal tandem duplication (ITD) mutation. Ideally, the status of the mutation needs to be proven in the current relapse. Nevertheless, patients with previous FLT3/ITD negative test from prior lines can be included based on local results in order to not delay the start of treatment. 2. And participants must have AML which is either:
- Untreated second relapse, in participants who are sufficiently fit to undergo another round of intensive chemotherapy, or
- Untreated first relapse, in participants who cannot tolerate additional anthracyclin
Where
- Phoenix, Arizona
- Little Rock, Arkansas
- Long Beach, California
- Orange, California
- San Francisco, California
- Aurora, Colorado
- New Haven, Connecticut
- Wilmington, Delaware
- Washington D.C., District of Columbia
- Fort Myers, Florida
- Gainesville, Florida
- Jacksonville, Florida
And 31 more locations — see the full list below.
Collaborators
Princess Maxima Center for Pediatric Oncology (European Sponsor), AbbVie, Roche-Genentech, EuPAL
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 19, 2026 · Source of record for eligibility and locations