Actively Recruiting

Phase 4
Age: 1Year - 18Years
All Genders
NCT06289673

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

Led by St. Jude Children's Research Hospital · Updated on 2026-05-01

850

Participants Needed

3

Research Sites

748 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 1Year - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 1 and 18.99 years
  • Diagnosis of acute lymphoblastic leukemia (ALL) with at least 25% bone marrow blasts or definitive evidence of ALL in peripheral blood if bone marrow sample unavailable
  • Diagnosis of lymphoblastic lymphoma (LLy) with immunophenotypic evidence of lymphoblastic cells, less than 25% bone marrow blasts, and fewer than 1,000 circulating blasts per microliter
  • Diagnosis of mixed phenotype acute leukemia (MPAL) with or without 25% bone marrow involvement, including leukemia or lymphoma forms
Not Eligible

You will not qualify if you...

  • Pregnancy or breastfeeding
  • Prior cancer treatment except for up to one dose of intrathecal chemotherapy, one dose of vincristine, or emergency radiotherapy for organ-compromising masses
  • Current ineligibility for available SJALL therapeutic studies due to prohibited therapy, lack of appropriate study, enrollment in competing trial, or similar reasons
  • Inability or unwillingness to provide written informed consent by participant or legal guardian
  • Presence of major pre-existing disorders such as ataxia telangiectasia, Fanconi anemia, or Charcot Marie Tooth disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Rady Children's Hospital

San Diego, California, United States, 92123

Actively Recruiting

2

Saint Francis Children's Hospital

Tulsa, Oklahoma, United States, 74136

Actively Recruiting

3

St. Jude Children's Research Hospital

Memphis, Tennessee, United States, 38105

Actively Recruiting

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Research Team

S

Seth E. Karol, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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