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RECRUITING
NCT06533748
PHASE2

Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma

Sponsor: St. Jude Children's Research Hospital

View on ClinicalTrials.gov

Summary

This is a Phase II clinical trial testing the use of two antigen-directed therapies, inotuzumab and blinatumomab, as part of induction therapy for children and young adults with newly diagnosed B-cell precursor acute lymphoblastic leukemia and lymphoma. Primary Objective * To assess if the flow-cytometry assessed MRD-negative remission rate following an immunotherapy-based Induction in NCI-high risk patients without favorable genetic features is higher than the results of similar patients treated on AALL1131. Secondary Objectives * To compare flow-cytometry assessed MRD-negative rates at the end of Induction for patients treated with this therapy compared to similar patients treated on TOT17. * To compare the rate of significant toxicities in patients treated with this therapy to those treated with standard-risk therapy on TOT17. * To assess the event free and overall survival of patients treated with this therapy.

Official title: SJALL23H: Combination Antigen-Directed Induction Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma

Key Details

Gender

All

Age Range

1 Year - 18 Years

Study Type

INTERVENTIONAL

Enrollment

128

Start Date

2025-01-23

Completion Date

2034-05

Last Updated

2026-02-12

Healthy Volunteers

No

Interventions

DRUG

Dexamethasone

Given orally (PO) or intravenously (IV).

DRUG

Vincristine

Given IV.

DRUG

Inotuzumab

Given IV.

DRUG

Blinatumomab

Given IV.

DRUG

Dasatinib

Given PO.

PROCEDURE

IT MHA

Given Intrathecal (IT), Age adjusted.

DRUG

Cyclophosphamide

Given IV.

DRUG

Cytarabine

Given IV or IT.

DRUG

Methotrexate

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

DRUG

6-Mercaptopurine

Given PO.

DRUG

Calaspargase

Given IV.

DRUG

Daunorubicin

Given IV.

DRUG

Thioguanine

Given PO (participants intolerant to mercaptopurine).

Locations (2)

Saint Francis Children's Hospital

Tulsa, Oklahoma, United States

St. Jude Children's Research Hospital

Memphis, Tennessee, United States