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NCT07770698 · ClinicalTrials.gov record · last posted 2026-08-18

A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia

StatusNot Yet Recruiting
PhasePhase 1/2
Started2026-10
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from the ClinicalTrials.gov record
The goal of this clinical trial is to learn if sonrotoclax (BGB-11417) is safe and may help treat children and adolescents with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) that has come back after treatment or has not responded to treatment. The study will also learn how the body processes sonrotoclax when it is given with other medicines. The main questions it aims to answer are: * Is sonrotoclax safe and well tolerated when given with other anti-cancer medicines? * How does the body absorb, process, and remove sonrotoclax? * Does treatment with sonrotoclax, in combination with other medicines, help reduce or eliminate leukemia? Researchers will give sonrotoclax together with other anti-cancer medicines to participants with relapsed or refractory AML or ALL. Participants will: * Take sonrotoclax in combination with other anti-cancer medicines * Have regular clinic visits for physical exams, blood tests, heart monitoring, and other safety assessments. * Provide blood samples to measure how the body processes sonrotoclax. * Have tests to evaluate how their leukemia responds to treatment. * Continue treatment as long as it is helping and side effects remain manageable, according to the study plan.
Trial Details
NCT Number NCT07770698
Lead Sponsor BeOne Medicines
Conditions Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, B-cell Acute Lymphoblastic Leukemia, Pediatric Cancer, Pediatric ALL, Relapsed, Pediatric ALL, Pediatric ALL, B Cell, Acute Myeloid Leukemia +4 more
Enrollment 30 participants
Start Date 2026-10
Primary Completion 2030-04-30 (estimated)
Study Completion 2031-09 (estimated)
Updated on ClinicalTrials.gov 2026-08-18