A Pilot and Surgical Study of Larotrectinib for Treatment of Children with Newly Diagnosed High-Grade Glioma with NTRK Fusion

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508953-16-00

Acronym

CONNECT1903

Enrollment

Registered

2024-05-15

Start date

2024-10-25

Completion date

Unknown

Last updated

2024-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newly diagnosed high grade glioma (HGG) including diffuse intrinsic pontine glioma (DIPG)

Brief summary

Disease control rate (CR, CCR, PR, SD) presented as frequency and percentage. Time frame: At the end of cycle 2, Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. Time frame: From Day 1 of Course 1 of combination treatment with chemotherapy/ from Day 1 of treatment after radiotherapy through 30 days following end of protocol treatment

Interventions

DRUGLarotrectinib Bayer

DRUGCYCLOPHOSPHAMIDE MONOHYDRATE

DRUGMETHOTREXATE

DRUGCARBOPLATIN

DRUGVINCRISTINE SULFATE

DRUGETOPOSIDE PHOSPHATE

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Disease control rate (CR, CCR, PR, SD) presented as frequency and percentage. Time frame: At the end of cycle 2, Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. Time frame: From Day 1 of Course 1 of combination treatment with chemotherapy/ from Day 1 of treatment after radiotherapy through 30 days following end of protocol treatment	—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026