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Phase 1RecruitingPriority 4 · Lower priorityNCT07001384

A Study of Alectinib and Duvelisib in People With Anaplastic Lymphoma Kinase-Positive Anaplastic Large Cell Lymphoma (ALK+ALCL)

ClinicalTrials.gov

Plain-language summary

This Phase 1 trial is testing Alectinib and Duvelisib for people whose anaplastic large cell lymphoma (ALCL) has come back or has not responded to previous treatment. The study starts with lower doses to find the safest effective dose before testing in more people. It is available at 7 US locations across multiple states.

Who can join (key eligibility)

  • Age 18 Years or older
  • Lymphoma came back or did not respond to prior treatment
  • Must be well enough for treatment (adequate performance status)
  • May require specific number of prior treatments

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

What's being tested

Alectinib (DRUG): All patients will receive a lead-in cycle (28 days) of alectinib. | Duvelisib (DRUG): After the lead-in cycle of alectinib, in the absence of progressive disease as assessed by PET/CT scan, all patients will then receive two 28-day cycles of alectinib plus duvelisib.

Drugs / treatments
Alectinib, Duvelisib
Treatment length
Ask the trial team for details
Visit frequency
Ask the trial team for details

At a glance

Phase
Phase 1
Status
Recruiting
Design
Non-randomized, open-label
Enrollment target
30 patients
Primary endpoint
Determine the maximum tolerated dose (MTD)
Ages
18 Years to —
Start date
2025-08-08
Est. completion
2031-08-08

Locations

7 US sites · 7 total

New JerseyNew York

Contact

Sponsor
Memorial Sloan Kettering Cancer Center (OTHER)
Contact
Robert Stuver, MD | stuverr@mskcc.org | 646-608-4308

Tags

ALCLMaintenanceRelapsed/Refractory
TrialCompass — Clinical Trial Summary

A Study of Alectinib and Duvelisib in People With Anaplastic Lymphoma Kinase-Positive Anaplastic Large Cell Lymphoma (ALK+ALCL)

NCT07001384

Phase: Phase 1 | Status: Recruiting | Priority: Lower

Plain-language summary

This Phase 1 trial is testing Alectinib and Duvelisib for people whose anaplastic large cell lymphoma (ALCL) has come back or has not responded to previous treatment. The study starts with lower doses to find the safest effective dose before testing in more people. It is available at 7 US locations across multiple states.

Who can join

  • Age 18 Years or older
  • Lymphoma came back or did not respond to prior treatment
  • Must be well enough for treatment (adequate performance status)
  • May require specific number of prior treatments

What's being tested

Alectinib (DRUG): All patients will receive a lead-in cycle (28 days) of alectinib. | Duvelisib (DRUG): After the lead-in cycle of alectinib, in the absence of progressive disease as assessed by PET/CT scan, all patients will then receive two 28-day cycles of alectinib plus duvelisib.

Drugs / treatments: Alectinib, Duvelisib

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: Determine the maximum tolerated dose (MTD)

Ages: 18 Years to —

Start date: 2025-08-08 | Est. completion: 2031-08-08

Locations

7 US sites · 7 total

New Jersey, New York

Contact

Robert Stuver, MD | stuverr@mskcc.org | 646-608-4308

Sponsor: Memorial Sloan Kettering Cancer Center (OTHER)

Tags

ALCL · Maintenance · Relapsed/Refractory

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT07001384

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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