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

NCT06289673 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: INITIALLNCI-2024-01659
• Study Type: interventional
• Target: 850
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma; Mixed Phenotype Acute Leukemia

Keywords

Newly Diagnosed; Risk Category; Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma; Mixed Phenotype Acute Leukemia (MPAL); Children; Young Adults

Outcome Measures

Primary Outcomes (2)

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

  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

  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 Outcomes (2)

• Event Free Survival (EFS)

  1, 3, 5 years from study entry

• Overall Survival (OS)

  1, 3, 5 years from study entry

Study Arms (1)

Newly diagnosed ALL, LLy, and MPAL patients

EXPERIMENTAL

All eligible patients receive the following intervention: Dexamethasone, Vincristine, Daunorubicin, Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine)

Drug: Dexamethasone; Drug: Vincristine; Drug: Daunorubicin; Drug: Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine); Drug: Methotrexate; Drug: Cytarabine

Interventions

Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine) DRUG

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

Also known as: ITMHA

Newly diagnosed ALL, LLy, and MPAL patients

Dexamethasone DRUG

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

Also known as: Decadron

Newly diagnosed ALL, LLy, and MPAL patients

Vincristine DRUG

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

Also known as: Vincristine Sulfate, Oncovin

Newly diagnosed ALL, LLy, and MPAL patients

Daunorubicin DRUG

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

Also known as: Daunomycin

Newly diagnosed ALL, LLy, and MPAL patients

Methotrexate DRUG

Given IT as part of Intrathecal triple therapy.

Also known as: MTX, Trexall®

Newly diagnosed ALL, LLy, and MPAL patients

Cytarabine DRUG

Given IT as part of Intrathecal triple therapy.

Also known as: Cytosine arabinoside, Ara-C

Newly diagnosed ALL, LLy, and MPAL patients

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• Pregnant or breastfeeding
• 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.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (3)

Rady Children's Hospital

San Diego, California, 92123, United States

RECRUITING

Saint Francis Children's Hospital

Tulsa, Oklahoma, 74136, United States

RECRUITING

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

RECRUITING

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Biphenotypic, Acute

Interventions

Dexamethasone; Calcium Dobesilate; Vincristine; Daunorubicin; Methotrexate; Hydrocortisone; Cytarabine

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Aminoglycosides; Glycosides; Carbohydrates; Aminopterin; Pterins; Pteridines; Pregnenediones; Pregnenes; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Seth E. Karol, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seth E. Karol, MD

CONTACT

888-226-4343; referralinfo@stjude.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 4, 2024
• Study Start: December 26, 2024
• Primary Completion (Estimated): May 1, 2034
• Study Completion (Estimated): May 1, 2039
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available at the time of article publication.
• 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.

Locations

US (3)