Actively Recruiting
Phase 1 Study of Alectinib Combined with Duvelisib for Adults with ALK-Positive Anaplastic Large Cell Lymphoma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-26
30
Participants Needed
7
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of alectinib combined with duvelisib as a time-limited treatment for people with relapsed or refractory ALK-positive anaplastic large cell lymphoma ALCL. This phase 1 study aims to find the highest doses of these drugs that cause few or mild side effects. After determining this dose combination, the study will assess how long the treatments effect lasts in a new group of participants. All participants first receive a 28-day lead-in cycle of alectinib. Following this, a PETCT scan and safety assessment are performed to check for disease progression. Those without progression continue treatment with two additional 28-day cycles combining alectinib and duvelisib. After these combination cycles, participants undergo a response evaluation. Participants will be involved in scans and safety assessments to monitor disease status and side effects. Researchers will measure the maximum tolerated dose over two years and track relapse-free rates for one year. The study includes laboratory tests, performance status assessments, and monitoring of medication adherence and side effects throughout the treatment period.
CONDITIONS
Brief Title
A Study of Alectinib and Duvelisib in People With Anaplastic Lymphoma Kinase-Positive Anaplastic Large Cell Lymphoma (ALK+ALCL)
Research Team
R
Robert Stuver, MD
S
Steven Horwitz, MD
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