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Risk Categorization for Treatment Assignment in Children and Young Adults with Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma, the INITIALL Trial
Trial Status: active
This phase IV trial utilizes risk categorization for treatment assignment in children and young adults with newly diagnosed acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LLy). Treatment for leukemia is risk-based, which means that treatment is based on several leukemia-specific features that can affect response to treatment. The term "risk" refers to the chance of the leukemia coming back after treatment. Due to the aggressive nature of ALL, chemotherapy is administered during collection of biologic samples and other data in order to reduce the number of cancer cells and lessen tumor lysis syndrome. Chemotherapy drugs, such as vincristine, daunorubicin, methotrexate, dexamethasone and cytarabine work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Determining risk categorization may improve appropriate assignment to therapy.
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/MAPL 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
Additional locations may be listed on ClinicalTrials.gov for NCT06289673.
I. 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.
II. To develop a central database of genomic and clinical findings.
SECONDARY OBJECTIVE:
I. To assess event free and overall survival data of patients enrolled on this study.
EXPLORATORY OBJECTIVES:
I. To evaluate the impact of somatic and germline genomic variations on in vitro drug sensitivity (pharmacotyping) and therapy response including disease response and treatment toxicity.
II. To collect samples for future studies and xenografting.
III. To assess neurocognitive and patient-reported quality of life outcomes during and shortly after therapy and to characterize and identify demographic, clinical, and environmental determinants of these outcomes.
IV. To assess the barriers and enablers of therapeutic SJALL administration across varied settings and examine how determinants impact feasibility, acceptability, and appropriateness.
V. To assess patterns of enrollment on SJALL therapeutic trials and non-therapeutic sub-studies of INITIALL.
OUTLINE:
Patients receive dexamethasone orally (PO) or intravenously (IV) on day 1 and twice daily (BID) on days 2-7, vincristine IV on day 1 or 2. Patients with T-ALL /T-LLy/mixed phenotype acute leukemia (MPAL) also receive daunorubicin IV on day 2 or 3. Patients also receive methotrexate, hydrocortisone, and cytarabine intrathecally (IT) on day 4, 5 or 6. Patients also undergo a chest x-ray during screening and blood sample collection, bone marrow aspiration, lumbar puncture, neurocognitive assessment throughout study. Patients with LLy also undergo computed tomography (CT), magnetic resonance imaging (MRI) or positron emission tomography (PET)/CT scans throughout study.
After completion of study treatment, patients are followed up within 2 weeks and at 2 years.
Trial PhasePhase IV
Trial Typetreatment
Lead OrganizationSaint Jude Children's Research Hospital
