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

NCT06289673 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 850

Last updated 2026-05-01

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

Principal Investigators

  • Seth E. Karol, MD · 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
2024-12-26
Primary Completion
2034-05-31
Completion
2039-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06289673 on ClinicalTrials.gov