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NCT06289673 | NOT YET RECRUITING | Acute Lymphoblastic Leukemia

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

St. Jude Children's Research Hospital

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 Leukemia (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.

Condition or disease

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Mixed Phenotype Acute Leukemia

Intervention/treatment

Dexamethasone

Vincristine

Daunorubicin

Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine)

Methotrexate

Cytarabine

Phase

PHASE4

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
Estimated Enrollment : 850 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : INITIALL: Identification of Necessary Information for Treatment Induction in Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma
Actual Study Start Date : 2024-12
Estimated Primary Completion Date : 2034-05
Estimated Study Completion Date : 2039-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 1 Year to 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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 only enroll participants who may subsequently enroll on an SJALL therapeutic trial. 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.
Identification of Necessary Information for Treatment Induction in Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma

Location Details

NCT06289673

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Tennessee

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

Memphis, Tennessee, United States, 38105