RecruitingPhase 2NCT06390319

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)

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)

Sponsor

St. Jude Children's Research Hospital

Enrollment

100 participants

Start Date

Dec 27, 2024

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 1 YearMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding dasatinib or venetoclax to standard chemotherapy improves outcomes in children and young adults newly diagnosed with T-cell leukemia (T-ALL), T-cell lymphoma (T-LLy), or a mixed type of leukemia (MPAL). **You may be eligible if...** - You are between 1 and 18 years old - You have been newly diagnosed with T-cell ALL, T-cell lymphoblastic lymphoma, or mixed phenotype acute leukemia - You are already enrolled in the INITIALL study and have had no more than 3 days of chemotherapy on that study - Your liver and kidney function are within acceptable limits for your age **You may NOT be eligible if...** - You have had prior chemotherapy outside of what is allowed by INITIALL - You have significant nerve damage (grade 2 or higher neuropathy) - You have a condition that prevents you from taking oral medications - You have HIV or active hepatitis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGDexamethasone

Given orally (PO) or intravenously (IV).

DRUGVincristine

Given IV.

DRUGDaunorubicin

Given IV.

DRUGCalaspargase pegol

Given IV.

DRUGDasatinib

Given PO

DRUGVenetoclax

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

DRUGBortezomib

Given IV (T-LLy only).

DRUGIntrathecal triple therapy (methotrexate + hydrocortisone + cytarabine)

Given Intrathecal (IT), Age adjusted.

DRUGCyclophosphamide

Given IV.

DRUGCytarabine

Given IV or IT.

DRUGMercaptopurine

Given PO.

DRUGNelarabine

Given IV

DRUGMethotrexate

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

DRUGThioguanine

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06390319

Related Trials

Identification of Necessary Information for Treatment Induction in Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma

NCT062896733 locations

CD4CAR for CD4+ Leukemia and Lymphoma

NCT038295406 locations

A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy in T-Cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma (T-RRex)

NCT0651479412 locations

Universal 4SCAR7U Targeting CD7-positive Malignancies

NCT059950281 location

First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia

NCT0406733656 locations