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

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.

Conditions

• Acute Lymphoblastic Leukemia
• Lymphoblastic Lymphoma

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).

Sponsors & Collaborators

• Pfizer

  collaborator INDUSTRY

• Amgen

  collaborator INDUSTRY

• St. Jude Children's Research Hospital

  lead OTHER

Principal Investigators

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

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

1 Year

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-23

Primary Completion

2028-05-31

Completion

2034-05-31

FDA Drug

Yes

Countries

• United States

Study Locations