NCT07001384

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

A Phase I Study of Alectinib Plus Duvelisib in Anaplastic Lymphoma Kinase-Positive Anaplastic Large Cell Lymphoma (ALK+ ALCL)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The researchers are doing this study to see if alectinib in combination with duvelisib is a safe and effective time-limited treatment for people with relapsed or refractory ALK+ anaplastic large cell lymphoma (ALCL). The researchers will test different doses of the study drugs to find the highest doses that cause few or mild side effects in participants. Once they find this dose combination, they will test it in a new group of participants to learn how long the effect of the combination lasts after the end of treatment

Conditions

• Anaplastic Lymphoma Kinase
• Anaplastic Large Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Alectinib	All patients will receive a lead-in cycle (28 days) of alectinib.
DRUG	Duvelisib	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.

Timeline

• Start date: 2025-08-08
• Primary completion: 2031-08-08
• Completion: 2031-08-08
• First posted: 2025-06-03
• Last updated: 2026-04-08

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study