Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)

ConditionAcute Myeloid Leukemia

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age29-21

SponsorPedAL BCU, LLC

About this trial

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.

Eligibility criteria

Qualifiers

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/Blood Cancer United territory).

Participants must be ≥ 29 days of age and ≤ 21 years of age at enrollment.

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.

Untreated second relapse, in participants who are sufficiently fit to undergo another round of intensive chemotherapy, or