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NCT06289673PHASE4Recruiting

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

St. Jude Children's Research Hospital

Start Date

12/26/2024

Completion Date

5/1/2039

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.

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.

Eligibility Criteria

Age Range: 1 years to 18 years

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.

Interventions

DRUG

Dexamethasone

DRUG

Vincristine

DRUG

Daunorubicin

DRUG

Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine)

DRUG

Methotrexate

DRUG

Cytarabine

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Conditions

Acute Lymphoblastic LeukemiaLymphoblastic LymphomaMixed Phenotype Acute Leukemia

Locations

Rady Children's Hospital

San Diego, California 92123

United States

Our Lady of the Lakes Regional Medical Center

Baton Rouge, Louisiana 70809

United States

Novant Health Presbyterian Hemby Children's Hospital

Charlotte, North Carolina 28204

United States

Saint Francis Children's Hospital

Tulsa, Oklahoma 74136

United States

St. Jude Children's Research Hospital

Memphis, Tennessee 38105

United States