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Study for Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma

This study is for children and teens aged 1 to 18 with newly diagnosed acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma (LLy), or mixed phenotype acute leukemia (MPAL). The goal is to give enough initial treatment with medicines like dexamethasone, vincristine, daunorubicin, and intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine) while doctors figure out the best long-term treatment plan for you. This initial treatment lasts for 7 days. Researchers will collect information about your leukemia or lymphoma to help decide your risk category, which tells them the chance of the cancer coming back. The study aims to gather this information by Day 8 and track it over several years.

Study design
This is an interventional study planning to enroll 850 participants. It is a single-arm study where all participants receive the same initial treatment.
What's involved
You would receive 7 days of chemotherapy, including oral or intravenous medications and an initial spinal tap with chemotherapy. Diagnostic procedures will also be performed.
Compensation
Not stated in the trial record.
Follow-up
Your data will be collected and tracked for up to 5 years after joining the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06289673

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

Recruiting
PHASE4Ages 1–18InterventionalTreatment
St. Jude Children's Research Hospital
~850 participants
Updated 2026-07-14 on ClinicalTrials.gov
What's tested:DexamethasoneVincristineDaunorubicinIntrathecal triple therapy (methotrexate + hydrocortisone + cytarabine)MethotrexateCytarabine

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sufficient phenotypic and/or genomic data necessary for therapeutic protocol assignment by Day 8 (completion of INITIALL therapy).
Measured over 1 week from study entry
+1 more outcome measured

Conditions

Acute Lymphoblastic Leukemia
Lymphoblastic Lymphoma
Mixed Phenotype Acute Leukemia

Explore related trials

Acute Lymphoblastic LeukemiaLymphoblastic LymphomaMixed Phenotype Acute Leukemia

Where it's being run

5 sites across 5 states
California1
Louisiana1
North Carolina1
Oklahoma1
Tennessee1

Study leadership

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

Who to contact

Seth E. Karol, MD
[email protected]
888-226-4343
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age 1-18.99 years
Diagnosis of acute leukemia / lymphoma as below:
Acute lymphoblastic leukemia (ALL) with at least 25% bone marrow blasts or definitive evidence of ALL in peripheral blood (in those without an available bone marrow sample).
Lymphoblastic lymphoma (LLy) with immunophenotypic evidence of a lymphoblastic population and \<25% bone marrow blasts and less than 1,000 circulating blasts/ microL.
Mixed phenotype acute leukemia (MPAL) with or without 25% bone marrow involvement (i.e. patients with either leukemia or lymphoma are eligible).

Exclusion

Pregnant or breastfeeding
Receipt of prior cancer directed therapy with the exclusion of up to 1 dose of intrathecal chemotherapy, 1 dose of vincristine, or emergency radiotherapy due to organ compromising malignant mass. There is no exclusion for prior steroid therapy.
Known to be currently ineligible for available SJALL therapeutic studies (e.g. receipt of prohibited therapy, no appropriate SJALL therapeutic study available, enrolled on competing trial, etc.).
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
Major pre-existing abnormalities such as ataxia telangiectasia, Fanconi anemia, Charcot Marie Tooth, etc.

What this trial measures

  • Sufficient phenotypic and/or genomic data necessary for therapeutic protocol assignment by Day 8 (completion of INITIALL therapy).1 week from study entry

    The proportion of patients with sufficient immunophenotypic, genomic, and clinical data to allow determination of eligibility for currently open trials at the enrolling institution.

  • Complete data within the INITIALL database3 months, 1 year, 3, 5 years from study entry

    The proportion of patients with complete data within the INITIALL protocol database as described in the protocol.