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Phase 1, Phase 2RecruitingPriority 3 · Moderate priorityNCT04925609

Brigatinib in Pediatric and Young Adult Patients With ALK+ ALCL, IMT or Other Solid Tumors

ClinicalTrials.gov

Plain-language summary

This Phase 1, Phase 2 trial is comparing different first-line treatment approaches for people newly diagnosed with ALK-positive ALCL. Patients are randomly assigned to different treatment groups to see which approach works best. This trial does not currently list US sites.

Who can join (key eligibility)

  • Age 1 Year to 25 Years years
  • Newly diagnosed, not yet treated
  • Must be well enough for treatment (adequate performance status)

Final eligibility is determined by the trial team. This list is a starting point only.

What's being tested

Brigatinib (DRUG): Brigatinib is a second generation novel, orally administered, tyrosine kinase inhibitor (TKI) that potently inhibits activated variants of ALK and to a lesser extent ROS1.

Drugs / treatments
Brigatinib
Treatment length
Ask the trial team for details
Visit frequency
Ask the trial team for details

At a glance

Phase
Phase 1, Phase 2
Status
Recruiting
Design
Non-randomized, open-label
Enrollment target
65 patients
Primary endpoint
Phase 1: assess the MTD/RP2D regimen; Phase 1: to characterize the PK of brigatinib; Phase 1: to characterize the PK of brigatinib; Phase 1: to characterize the PK of brigatinib; Phase 2: ORR in IMT; Phase 2: EFS in ALCL
Ages
1 Year to 25 Years
Start date
2022-08-18
Est. completion
2033-12

Locations

0 US sites · 2 total

No US sites currently listed.

Contact

Sponsor
Princess Maxima Center for Pediatric Oncology (OTHER)
Contact
Maaike Boonstra | m.boonstra@prinsesmaximacentrum.nl | +31642055985

Tags

ALCL ALK+Newly diagnosedRelapsed/Refractory
TrialCompass — Clinical Trial Summary

Brigatinib in Pediatric and Young Adult Patients With ALK+ ALCL, IMT or Other Solid Tumors

NCT04925609

Phase: Phase 1, Phase 2 | Status: Recruiting | Priority: Medium

Plain-language summary

This Phase 1, Phase 2 trial is comparing different first-line treatment approaches for people newly diagnosed with ALK-positive ALCL. Patients are randomly assigned to different treatment groups to see which approach works best. This trial does not currently list US sites.

Who can join

  • Age 1 Year to 25 Years years
  • Newly diagnosed, not yet treated
  • Must be well enough for treatment (adequate performance status)

What's being tested

Brigatinib (DRUG): Brigatinib is a second generation novel, orally administered, tyrosine kinase inhibitor (TKI) that potently inhibits activated variants of ALK and to a lesser extent ROS1.

Drugs / treatments: Brigatinib

Treatment length: Ask the trial team for details

Visit frequency: Ask the trial team for details

Trial design

Non-randomized, open-label

Enrollment target: 65 patients

Primary endpoint: Phase 1: assess the MTD/RP2D regimen; Phase 1: to characterize the PK of brigatinib; Phase 1: to characterize the PK of brigatinib; Phase 1: to characterize the PK of brigatinib; Phase 2: ORR in IMT; Phase 2: EFS in ALCL

Ages: 1 Year to 25 Years

Start date: 2022-08-18 | Est. completion: 2033-12

Locations

0 US sites · 2 total

Contact

Maaike Boonstra | m.boonstra@prinsesmaximacentrum.nl | +31642055985

Sponsor: Princess Maxima Center for Pediatric Oncology (OTHER)

Tags

ALCL ALK+ · Newly diagnosed · Relapsed/Refractory

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT04925609

Prepared using TrialCompass (trialcompass.com) on June 19, 2026. For informational purposes only. Always discuss with your healthcare team.
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Data sourced from ClinicalTrials.gov.

For informational purposes only. Not medical advice — always consult your healthcare team.

Built with care for the rare cancer community.

Data last updated: June 2026

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