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

Last updated: February 27, 2026
Sponsor: St. Jude Children's Research Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Lymphoproliferative Disorders

Lymphoma

Leukemia

Treatment

Cytarabine

Vincristine

Dexamethasone

Clinical Study ID

NCT06289673
INITIALL
NCI-2024-01659
  • Ages 1-18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 1-18.99 years

  • Diagnosis of acute leukemia / lymphoma as below:

  • Acute lymphoblastic leukemia (ALL) with at least 25% bone marrow blasts ordefinitive evidence of ALL in peripheral blood (in those without an availablebone marrow sample).

  • Lymphoblastic lymphoma (LLy) with immunophenotypic evidence of a lymphoblasticpopulation and <25% bone marrow blasts and less than 1,000 circulating blasts/microL.

  • Mixed phenotype acute leukemia (MPAL) with or without 25% bone marrowinvolvement (i.e. patients with either leukemia or lymphoma are eligible).

Exclusion

Exclusion Criteria:

  • Pregnant or breastfeeding

  • Receipt of prior cancer directed therapy with the exclusion of up to 1 dose ofintrathecal chemotherapy, 1 dose of vincristine, or emergency radiotherapy due toorgan 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.).

Note: The intention of this exclusion criterion is to enroll all newly diagnosed ALL/ LLy/ MPAL patients. If participant is screened as a potential participant for subsequent SJALL and later found to be ineligible due to information obtained during INITIALL, this will not make the participant ineligible for INITIALL.

  • Inability or unwillingness of research participant or legal guardian/representativeto give written informed consent.

  • Major pre-existing abnormalities such as ataxia telangiectasia, Fanconi anemia,Charcot Marie Tooth, etc.

Study Design

Total Participants: 850
Treatment Group(s): 6
Primary Treatment: Cytarabine
Phase: 4
Study Start date:
December 26, 2024
Estimated Completion Date:
May 31, 2039

Study Description

Patients with newly diagnosed acute lymphoblastic leukemia/lymphoma (ALL/LLy) and mixed phenotype acute leukemia/lymphoma (MPAL) will undergo diagnostic procedures either during screening or on Day 1. They will receive 7 days of chemotherapy including 13 doses of dexamethasone, 1 dose of vincristine, and 1 dose of daunorubicin (for patients with T-ALL/LLy or MPAL only). Patients will also undergo their initial lumbar puncture with intrathecal chemotherapy on Days 4 or 5 or 6 of therapy. After the completion of 7 days of chemotherapy, patients will begin therapy on either a SJALL therapeutic trial or will receive non-protocol therapy.

Connect with a study center

  • Rady Children's Hospital

    San Diego 5391811, California 5332921 92123
    United States

    Active - Recruiting

  • Saint Francis Children's Hospital

    Tulsa, Oklahoma 74136
    United States

    Site Not Available

  • Saint Francis Children's Hospital

    Tulsa 4553433, Oklahoma 4544379 74136
    United States

    Active - Recruiting

  • St. Jude Children's Research Hospital

    Memphis, Tennessee 38105
    United States

    Site Not Available

  • United States, Tennessee St. Jude Children's Research Hospital

    Memphis, Tennessee 38105
    United States

    Active - Recruiting

  • St. Jude Children's Research Hospital

    Memphis 4641239, Tennessee 4662168 38105
    United States

    Active - Recruiting

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