Identification of Necessary Information for Treatment Induction in Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma
NCT ID: NCT06289673
Last Updated: 2025-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
850 participants
INTERVENTIONAL
2024-12-26
2039-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Newly diagnosed ALL, LLy, and MPAL patients
All eligible patients receive the following intervention:
Dexamethasone, Vincristine, Daunorubicin, Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine)
Dexamethasone
Per mouth (PO) or intravenously (IV) once on Day 1 and PO or IV divided BID (every 12 hours) days 2-7
Vincristine
Intravenously (IV) for 1 dose on Day 1 or 2
Daunorubicin
Intravenously (IV) for 1 dose on Day 2 or 3 (T-ALL/ T-LLy/ MPAL only)
Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine)
Intrathecal (Age adjusted) for 1 dose on Day 4 or 5 or 6
Methotrexate
Given IT as part of Intrathecal triple therapy.
Cytarabine
Given IT as part of Intrathecal triple therapy.
Interventions
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Dexamethasone
Per mouth (PO) or intravenously (IV) once on Day 1 and PO or IV divided BID (every 12 hours) days 2-7
Vincristine
Intravenously (IV) for 1 dose on Day 1 or 2
Daunorubicin
Intravenously (IV) for 1 dose on Day 2 or 3 (T-ALL/ T-LLy/ MPAL only)
Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine)
Intrathecal (Age adjusted) for 1 dose on Day 4 or 5 or 6
Methotrexate
Given IT as part of Intrathecal triple therapy.
Cytarabine
Given IT as part of Intrathecal triple therapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
1 Year
18 Years
ALL
No
Sponsors
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St. Jude Children's Research Hospital
OTHER
Responsible Party
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Principal Investigators
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Seth E. Karol, MD
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Locations
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Rady Children's Hospital
San Diego, California, United States
Saint Francis Children's Hospital
Tulsa, Oklahoma, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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St. Jude Children's Research Hospital
Clinical Trials Open at St. Jude
Other Identifiers
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NCI-2024-01659
Identifier Type: REGISTRY
Identifier Source: secondary_id
INITIALL
Identifier Type: -
Identifier Source: org_study_id
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