Health Trials

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

This trial does not accept healthy volunteers

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 >28 days of age and < 22 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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fludarabine

    Drug

    Intravenous (IV) infusion

  • Cytarabine

    Drug

    Intravenous (IV) infusion

  • Gemtuzumab Ozogamicin

    Drug

    Intravenous (IV) infusion

  • Azacitidine

    Drug

    Intravenous (IV) infusion or subcutaneous injection

  • Venetoclax

    Drug

    Orally via tablet or powder suspension

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Arm A: Control Arm without VenetoclaxActive comparator 4 interventions
Group B: Arm B: Experimental Arm with VenetoclaxExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Overall Survival (OS)

Time frame
Up to 5 years

Secondary outcomes

1

Morphology Event Free Survival (EFS)

Time frame
Up to 5 years
2

Flow-based Event Free Survival (EFS)

Time frame
Up to 5 years
3

Flow-based Overall Response Rate (ORR)

Time frame
Up to Day 84
4

Morphological Overall Response Rate (ORR)

Time frame
Up to Day 84

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

PedAL BCU, LLC

Lead sponsor

Princess Maxima Center for Pediatric Oncology (European Sponsor)

Collaborator

AbbVie

Collaborator

Roche-Genentech

Collaborator

EuPAL

Collaborator

Source ClinicalTrials.gov
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