Clinical Research Directory
Browse clinical research sites, groups, and studies.
Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL)
Sponsor: St. Jude Children's Research Hospital
Summary
This is a clinical trial testing whether the addition of one of two chemotherapy agents, dasatinib or venetoclax, can improve outcomes for children and young adults with newly diagnosed T-cell acute lymphoblastic leukemia and lymphoma or mixed phenotype acute leukemia. Primary Objective * To evaluate if the end of induction MRD-negative rate is higher in patients with T-ALL treated with dasatinib compared to similar patients treated with 4-drug induction on AALL1231. * To evaluate if the end of induction MRD-negative rate is higher in patients with ETP or near-ETP ALL treated with venetoclax compared to similar patients treated with 4-drug induction on AALL1231. Secondary Objectives * To assess the event free and overall survival of patients treated with this therapy. * To compare grade 4 toxicities, event-free survival (EFS) and overall survival (OS) of patients treated with this therapy in induction and reinduction to toxicities of similar patients treated on TOT17.
Official title: SJALL23T: Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL)
Key Details
Gender
All
Age Range
1 Year - 18 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2024-12-27
Completion Date
2033-12
Last Updated
2026-02-27
Healthy Volunteers
No
Interventions
Dexamethasone
Given orally (PO) or intravenously (IV).
Vincristine
Given IV.
Daunorubicin
Given IV.
Calaspargase pegol
Given IV.
Dasatinib
Given PO
Venetoclax
Given PO (ETP, near-ETP, and MPAL only).
Bortezomib
Given IV (T-LLy only).
Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine)
Given Intrathecal (IT), Age adjusted.
Cyclophosphamide
Given IV.
Cytarabine
Given IV or IT.
Mercaptopurine
Given PO.
Nelarabine
Given IV
Methotrexate
Given IT, IV, PO or intramuscular (IM).
Thioguanine
Given PO (participants intolerant to mercaptopurine).
Locations (3)
Rady Children's Hospital
San Diego, California, United States
Saint Francis Children's Hospital
Tulsa, Oklahoma, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States