RecruitingAcute Myeloid Leukemia

Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)

Eligible age

0–21 yrs

Accepts

All genders

Locations

31 states

Healthy volunteers

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About this study

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.

Sponsor: PedAL BCU, LLC

You may qualify if…

✓ 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.
✓ 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 anthracycline containing chemotherapy per investigator discretion.
✓ Participants must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2 (≥ 50% Lansky or Karnofsky score).

You may not qualify if…

✕ Participants who in the opinion of the investigator may not be able to comply with the study requirements of the study, are not eligible.
✕ Participants with Down syndrome.
✕ Participants with Acute promyelocytic leukemia (APL) or Juvenile myelomonocytic leukemia (JMML).
✕ Participants with isolated CNS3 disease or symptomatic CNS3 disease.
✕ Participants with malabsorption syndrome or any other condition that precludes enteral administration of venetoclax.
✕ Participants who are currently receiving an investigational drug other than those specified for this study.
✕ Participants with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known congenital bone marrow failure syndrome.
✕ Participants with known prior allergy to any of the medications used in protocol therapy.