RecruitingPhase 4NCT06289673

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

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


Sponsor

St. Jude Children's Research Hospital

Enrollment

850 participants

Start Date

Dec 26, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 1 YearMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at what information doctors need right at the start of treatment for children newly diagnosed with acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma — a cancer of the blood and lymph system. The goal is to identify which early test results are most critical for guiding treatment decisions. **You may be eligible if...** - Your child is between 1 and 18 years old - Your child has been newly diagnosed with ALL, lymphoblastic lymphoma, or mixed phenotype acute leukemia (a cancer involving multiple blood cell types) **You may NOT be eligible if...** - The patient is pregnant or breastfeeding - The patient has already received cancer treatment (with limited exceptions such as a single dose of certain chemotherapy drugs or emergency radiation) 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGDexamethasone

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

DRUGVincristine

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

DRUGDaunorubicin

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

DRUGIntrathecal triple therapy (methotrexate + hydrocortisone + cytarabine)

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

DRUGMethotrexate

Given IT as part of Intrathecal triple therapy.

DRUGCytarabine

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06289673


Related Trials