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)

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.

Description

Eligibility

Age range

1–18 years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Dexamethasone

  Given orally (PO) or intravenously (IV).

• Drug
  Vincristine

  Given IV.

• Drug
  Daunorubicin

  Given IV.

• Drug
  Calaspargase pegol

  Given IV.

• Drug
  Dasatinib

  Given PO

• Drug
  Venetoclax

  Given PO (ETP, near-ETP, and MPAL only).

• Drug
  Bortezomib

  Given IV (T-LLy only).

Locations (3)