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

ConditionsRelapsed Acute Myeloid LeukemiaRefractory Acute Myeloid LeukemiaB-cell Acute Lymphoblastic LeukemiaPediatric CancerPediatric ALL, RelapsedPediatric ALLPediatric ALL, B CellAcute Myeloid LeukemiaAcute Lymphoblastic LeukemiaPediatric AMLR/R AMLR/R B-cell ALL
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age6-17
SponsorBeOne Medicines

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have a performance status of Lansky ≥50 for participants ≤16 years of age or Karnofsky ≥50 for participants >16 years of age.

Have adequate renal function, defined as an estimated or measured glomerular filtration rate (GFR) ≥60 mL/min.

Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2.5 × the institutional upper limit of normal (ULN)

Total bilirubin ≤1.5 × the institutional ULN.

Disqualifiers

Have central nervous system (CNS) 2 or CNS 3 disease at screening.

Have toxicity from prior anticancer therapy that has not recovered to ≤Grade 1, as defined by the applicable toxicity grading criteria.

Have a history of prior allogeneic stem cell transplantation <90 days from enrollment or if if ≥ 90 days from enrollment, with active graft-versus-host disease (GVHD), or requiring immunosuppressive drugs for treatment of GVHD, or have taken calcineurin inhibitors within 4 weeks prior to consent.

Have a diagnosis of acute promyelocytic leukemia (APL) or juvenile myelomonocytic leukemia (JMML).

Trial design

Design model

Single group

Treatments tested in this trial

  • sonrotoclax

    Drug

    Administered orally as a tablet

  • Azacitidine

    Drug

    administered intravenously or subcutaneously

  • Inotuzumab ozogamicin

    Drug

    administered via intravenous infusion

  • Dexamethasone

    Drug

    administered via intravenous injection or orally

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Cohort 1: Sonrotoclax + Azacitidine (R/R AML)Experimental treatment 2 interventions
Group B: Cohort 2: Sonrotoclax + Inotuzumab Ozogamicin + Dexamethasone (R/R B-cell ALL)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Assessed by treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and laboratory abnormalities,. Includes adverse events meeting protocol-defined dose-limiting toxicity (DLT) criteria.

Time frame
From first dose of study drug to 30 days after last dose; up to approximately 12 months in cohort 1 and 4 months in cohort 2.
2

Part 1: Recommended Dose for Expansion (RDFE) of Sonrotoclax

Dose selected based on safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity observed in Part 1, as determined by the Safety Monitoring Committee (SMC)

Time frame
From first dose through end of Cycle 1 (each cycle is 28 days); approximately 2 months

Secondary outcomes

1

Complete Remission (CR) Rate

Percentage of participants achieving a best overall response of complete remission (CR), as assessed by investigator's review

Time frame
Up to approximately 2 months
2

Area Under the Curve From Time Zero to Last Measurable Concentration (AUClast) for Sonrotoclax

Time frame
Up to approximately 1 month
3

Maximum Observed Plasma Concentration (Cmax) for Sonrotoclax

Time frame
Up to approximately 1 month
4

Plasma Concentration Measured Immediately Prior to the Next Scheduled Dose (Ctrough) for Sonrotoclax

Time frame
Up to approximately 1 month

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

BeOne Medicines

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: