RecruitingPhase 2NCT06533748

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

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


Sponsor

St. Jude Children's Research Hospital

Enrollment

128 participants

Start Date

Jan 23, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 1 YearMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests an intensive treatment regimen for children and young adults with high-risk B-cell acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) — blood and lymph node cancers that require aggressive treatment when they present with certain high-risk features. The study builds on an earlier baseline study (called INITIALL) and offers more intensive therapy for patients whose cancer is considered higher risk based on specific clinical or biological factors. **You may be eligible if...** - You are 1 to 18 years old and previously enrolled in the INITIALL study - You have B-cell ALL or lymphoblastic lymphoma - You meet at least one high-risk feature: older age (10+), high white blood cell count at diagnosis, cancer in the brain or spinal fluid, testicular involvement, certain steroid pre-treatment, or stage 3-4 lymphoblastic lymphoma - Your liver and kidney function meet the minimum required levels **You may NOT be eligible if...** - You did not enroll in the INITIALL study - You received chemotherapy outside of what is allowed by INITIALL - You do not meet the high-risk clinical criteria described - Your liver or kidney function is below the required thresholds 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.

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Interventions

DRUGDexamethasone

Given orally (PO) or intravenously (IV).

DRUGVincristine

Given IV.

DRUGInotuzumab

Given IV.

DRUGBlinatumomab

Given IV.

DRUGDasatinib

Given PO.

PROCEDUREIT MHA

Given Intrathecal (IT), Age adjusted.

DRUGCyclophosphamide

Given IV.

DRUGCytarabine

Given IV or IT.

DRUGMethotrexate

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

DRUG6-Mercaptopurine

Given PO.

DRUGCalaspargase

Given IV.

DRUGDaunorubicin

Given IV.

DRUGThioguanine

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

View Full Details on ClinicalTrials.gov

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NCT06533748


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