MedTrace Logo

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

NCT07001384 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-08

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Robert Stuver, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-08
Primary Completion
2031-08-08
Completion
2031-08-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07001384 on ClinicalTrials.gov