drugset / Trial / NCT06390319

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)

NCT06390319

Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2024-12-27
Primary completion
2027-12
Completion
2033-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule Intravenous
Subject Venetoclax Small molecule Oral
Subject dasatinib anhydrous Small molecule Oral
Background Calaspargase Pegol Protein / enzyme biologic Intravenous
Background Cyclophosphamide Other / unclassified Intravenous
Background Cytarabine Small molecule Intravenous
Background Daunorubicin Small molecule Intravenous
Background Dexamethasone Small molecule Oral
Background Hydrocortisone Other / unclassified Intrathecal
Background MERCAPTOPURINE ANHYDROUS Small molecule Oral
Background Methotrexate Small molecule Intrathecal
Background Nelarabine Small molecule Intravenous
Background Thioguanine Small molecule Oral
Background Vincristine Small molecule Intravenous