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

April 29, 2026 updated by: St. Jude Children's Research Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

850

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92123
        • Recruiting
        • Rady Children's Hospital
        • Contact:
        • Principal Investigator:
          • Victor Wong, MD
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Recruiting
        • Saint Francis Children's Hospital
        • Contact:
        • Principal Investigator:
          • Ashraf Mohamed, MD
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • Recruiting
        • St. Jude Children's Research Hospital
        • Principal Investigator:
          • Seth E. Karol, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 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 Criteria:

  • 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.).

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/representative to give written informed consent.
  • Major pre-existing abnormalities such as ataxia telangiectasia, Fanconi anemia, Charcot Marie Tooth, etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Newly diagnosed ALL, LLy, and MPAL patients

All eligible patients receive the following intervention:

Dexamethasone, Vincristine, Daunorubicin, Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine)
Drug: Dexamethasone
Per mouth (PO) or intravenously (IV) once on Day 1 and PO or IV divided BID (every 12 hours) days 2-7
Other Names:
  • Decadron
Drug: Vincristine
Intravenously (IV) for 1 dose on Day 1 or 2
Other Names:
  • Oncovin
  • Vincristine Sulfate
Drug: Daunorubicin
Intravenously (IV) for 1 dose on Day 2 or 3 (T-ALL/ T-LLy/ MPAL only)
Other Names:
  • Daunomycin
Drug: Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine)
Intrathecal (Age adjusted) for 1 dose on Day 4 or 5 or 6
Other Names:
  • ITMHA
Drug: Methotrexate
Given IT as part of Intrathecal triple therapy.
Other Names:
  • MTX
  • Trexall®
Drug: Cytarabine
Given IT as part of Intrathecal triple therapy.
Other Names:
  • Ara-C
  • Cytosine arabinoside

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sufficient phenotypic and/or genomic data necessary for therapeutic protocol assignment by Day 8 (completion of INITIALL therapy).
Time Frame: 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.
1 week from study entry
Complete data within the INITIALL database
Time Frame: 3 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.
3 months, 1 year, 3, 5 years from study entry

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event Free Survival (EFS)
Time Frame: 1, 3, 5 years from study entry
EFS will be reported as estimates using the Kaplan-Meier method.
1, 3, 5 years from study entry
Overall Survival (OS)
Time Frame: 1, 3, 5 years from study entry
OS will be reported as estimates using the Kaplan-Meier method.
1, 3, 5 years from study entry

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Jude Children's Research Hospital

Investigators

  • Principal Investigator: Seth E. Karol, MD, St. Jude Children's Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 26, 2024

Primary Completion (Estimated)

May 1, 2034

Study Completion (Estimated)

May 1, 2039

Study Registration Dates

First Submitted

February 23, 2024

First Submitted That Met QC Criteria

February 23, 2024

First Posted (Actual)

March 4, 2024

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INITIALL
  • NCI-2024-01659 (Registry Identifier: NCI Clinical Trial Registration Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.

IPD Sharing Time Frame

Data will be made available at the time of article publication.

IPD Sharing Access Criteria

Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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