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Phase 2, Phase 3RecruitingPriority 3 · Moderate priorityNCT05770037

DETERMINE Trial Treatment Arm 01: Alectinib in Adult, Paediatric and Teenage/Young Adult Patients With ALK Positive Cancers

ClinicalTrials.gov

Plain-language summary

This Phase 2, Phase 3 trial is studying Alectinib for people with anaplastic large cell lymphoma (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)

  • Must be well enough for treatment (adequate performance status)
  • See full trial listing for complete eligibility

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

What's being tested

Alectinib (DRUG): Adult patients will be administered alectinib orally at a dose of 600 mg (four 150 mg capsules) twice daily. Paediatric patients with a body weight ≥40 kg and who are able to swallow the capsules, will be administered alectinib orally at a dose of 600 mg (four 150 mg capsules) twice daily. Each cycle of treatment will consist of 28 days and patients may continue on treatment until disease progression without clinical benefit, unacceptable AEs or withdrawal of consent.

Drugs / treatments
Alectinib
Treatment length
Ask the trial team for details
Visit frequency
Ask the trial team for details
TrialCompass — Clinical Trial Summary

DETERMINE Trial Treatment Arm 01: Alectinib in Adult, Paediatric and Teenage/Young Adult Patients With ALK Positive Cancers

NCT05770037

Phase: Phase 2, Phase 3 | Status: Recruiting | Priority: Medium

Plain-language summary

This Phase 2, Phase 3 trial is studying Alectinib for people with anaplastic large cell lymphoma (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

  • Must be well enough for treatment (adequate performance status)
  • See full trial listing for complete eligibility

What's being tested

Alectinib (DRUG): Adult patients will be administered alectinib orally at a dose of 600 mg (four 150 mg capsules) twice daily. Paediatric patients with a body weight ≥40 kg and who are able to swallow the capsules, will be administered alectinib orally at a dose of 600 mg (four 150 mg capsules) twice daily. Each cycle of treatment will consist of 28 days and patients may continue on treatment until disease progression without clinical benefit, unacceptable AEs or withdrawal of consent.

Drugs / treatments: Alectinib

Treatment length: Ask the trial team for details

Visit frequency: Ask the trial team for details

Trial design

Non-randomized, open-label

Enrollment target: 30 patients

Primary endpoint: Objective Response (OR); Durable Clinical Benefit (DCB)

Ages: — to —

Start date: 2023-12-18 | Est. completion: 2029-10

Locations

0 US sites · 27 total

Contact

Aida Sarmiento Castro | determine@cancer.org.uk | +44 207 242 0200

Sponsor: Cancer Research UK (OTHER)

Tags

ALCL · any

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT05770037

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