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.

Conditions

• T-cell Acute Lymphoblastic Leukemia
• T-cell Lymphoma
• Mixed Phenotype Acute Leukemia

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).

DRUG

Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine)

Given Intrathecal (IT), Age adjusted.

DRUG

Cyclophosphamide

Given IV.

DRUG

Cytarabine

Given IV or IT.

DRUG

Mercaptopurine

Given PO.

DRUG

Nelarabine

Given IV

DRUG

Methotrexate

Given IT, IV, PO or intramuscular (IM).

DRUG

Thioguanine

Given PO (participants intolerant to mercaptopurine).

Sponsors & Collaborators

• AbbVie

  collaborator INDUSTRY

• St. Jude Children's Research Hospital

  lead OTHER

Principal Investigators

• Seth E. Karol, MD, MSCI · St. Jude Children's Research Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-27

Primary Completion

2027-12-31

Completion

2033-12-31

FDA Drug

Yes

Countries

• United States

Study Locations