drugset / Trial / NCT05183035
Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)
Phase 3
Recruiting
130 enrolled
PedAL BCU, LLC
AbbVie · collabEuPAL · collabPrincess Maxima Center for Pediatric Oncology (European Sponsor) · collabRoche-Genentech · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2022-10-01
- Primary completion
- 2027-02
- Completion
- 2031-04
Publications
- Daniels KP, Pounds SB, Wu H, Wang L, Alexander TB, Budhraja A, Wolf J, Westover T, Mead PE, Mehr CM, Gupta SD, Lacayo NJ, Inaba H, Rees M, Pui CH, Opferman JT, Klco JM, Rubnitz JE, Karol SE. Venetoclax in combination with cytarabine with or without idarubicin or azacitidine in children, adolescents, and young adults with relapsed or refractory acute myeloid leukaemia (VENAML): a multicentre, phase 1 expansion study. Lancet Haematol. 2026 Jul 8:S2352-3026(26)00136-5. doi: 10.1016/S2352-3026(26)00136-5. Online ahead of print.
- Badawi M, Gopalakrishnan S, Engelhardt B, Palenski T, Karol SE, Rubnitz JE, Menon R, Salem AH. Dosing of Venetoclax in Pediatric Patients with Relapsed Acute Myeloid Leukemia: Analysis of Developmental Pharmacokinetics and Exposure-Response Relationships. Clin Ther. 2024 Oct;46(10):759-767. doi: 10.1016/j.clinthera.2024.09.008. Epub 2024 Oct 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Venetoclax | Small molecule | 600 mg | Oral |
| Background | Azacitidine | Other / unclassified | — | Intravenous |
| Background | Cytarabine | Small molecule | 2 g | Intravenous |
| Background | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |
| Background | Gemtuzumab Ozogamicin | Monoclonal antibody | 3 mg/m2 | Intravenous |