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RECRUITING
NCT06289673
PHASE4

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

Sponsor: St. Jude Children's Research Hospital

View on ClinicalTrials.gov

Summary

The goal of this study is to provide sufficient therapy during the time a patients' B-cell Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LLy) risk category is being determined. The term "risk" refers to the chance of the ALL or LLy coming back after treatment. Primary Objectives * To provide sufficient therapy to enable testing of newly diagnosed acute lymphoblastic leukemia/lymphoma and mixed phenotype acute leukemia/lymphoma tumor samples to determine eligibility and appropriate risk stratification for SJALL therapeutic studies. * To develop a central database of genomic and clinical findings. Secondary Objectives * To assess event free and overall survival data of patients enrolled on this study.

Official title: INITIALL: Identification of Necessary Information for Treatment Induction in Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma

Key Details

Gender

All

Age Range

1 Year - 18 Years

Study Type

INTERVENTIONAL

Enrollment

850

Start Date

2024-12-26

Completion Date

2039-05

Last Updated

2026-03-03

Healthy Volunteers

No

Interventions

DRUG

Dexamethasone

Per mouth (PO) or intravenously (IV) once on Day 1 and PO or IV divided BID (every 12 hours) days 2-7

DRUG

Vincristine

Intravenously (IV) for 1 dose on Day 1 or 2

DRUG

Daunorubicin

Intravenously (IV) for 1 dose on Day 2 or 3 (T-ALL/ T-LLy/ MPAL only)

DRUG

Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine)

Intrathecal (Age adjusted) for 1 dose on Day 4 or 5 or 6

DRUG

Methotrexate

Given IT as part of Intrathecal triple therapy.

DRUG

Cytarabine

Given IT as part of Intrathecal triple therapy.

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