RecruitingPhase 1NCT07001384

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)

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

30 participants

Start Date

Aug 8, 2025

Study Type

INTERVENTIONAL

Conditions

Anaplastic Large Cell Lymphoma Anaplastic Lymphoma Kinase

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether the combination of two drugs — alectinib (a targeted therapy) and duvelisib (a PI3K inhibitor) — can treat a rare type of blood cancer called ALK-positive Anaplastic Large Cell Lymphoma (ALK+ ALCL) that has come back or stopped responding to prior treatment. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of ALK+ ALCL - Your lymphoma has relapsed or is no longer responding after at least one prior chemotherapy-based treatment - You are in reasonably good health (ECOG 0–2) - Prior treatment with an ALK inhibitor is allowed - Your blood counts and organ function meet the study requirements **You may NOT be eligible if...** - You have never had any systemic treatment before - You have certain serious infections, severe organ problems, or active autoimmune conditions - You are pregnant or breastfeeding - You have uncontrolled central nervous system disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAlectinib

All patients will receive a lead-in cycle (28 days) of alectinib.

DRUGDuvelisib

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.