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ADVL1823: Larotrectinib (LOXO-101) in Children with TRK Fusion Solid Tumors and Relapsed Leukemia

About this study

This is a Phase II study of larotrectinib, a type of drug that works by blocking cell signal proteins that are thought to be important for tumors to grow. In a Phase II study, the goal is to find out what effects, good and/or bad, a drug or combination of drugs has on people with a type of cancer.

We are using larotrectinib in this study because it has been shown to block the growth of cancer cells with TRK fusions in children and adults who have TRK fusion cancers that have not gone away or have come back after standard therapy. In children and adults with TRK fusion cancers, larotrectinib has caused tumors to shrink in most but not all patients. This study will evaluate what the effects of larotrectinib are if given at the time cancer is first diagnosed instead of standard therapy. We do not know if it will work against your cancer.

Larotrectinib has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of children and adults with TRK fusion cancers that have spread after standard therapy, are not able to be surgically removed after standard therapy, or for whom there is no standard therapy available. Using larotrectinib to treat patients with newly diagnosed TRK fusion cancers, as is being done in this study, is still experimental.

Eligibility overview

  • 21 years old or younger
  • Newly diagnosed infantile fibrosarcoma or solid tumor with NTRK1, NTRK2 or NTRK3 fusion OR
  • Relapsed/refractory acute leukemia with NTRK1, NTRK2 or NTRK3 fusion

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.


Full title:

Larotrectinib for Previously Untreated TRK Fusion Pediatric Solid Tumors and TRK Fusion Relapsed Pediatric Acute Leukemias

Study goal:

The main goals of this study are to find out the good and/or bad effects larotrectinib has on your type of cancer. Researchers also want to learn more about the side effects of larotrectinib and how larotrectinib works against cancer cells.


Solid tumors, leukemias


21 years or younger

Clinical trials categories:

Childhood Cancer Solid Tumors Lymphoma Leukemia

For physicians and researchers

Patients accepted to St. Jude must be referred by a physician or other qualified medical professional. Learn how St. Jude can partner with you to care for your patient.


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