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Identification of Necessary Information for Treatment Induction in Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma
Sponsor: St. Jude Children's Research Hospital
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.
Official title: INITIALL: Identification of Necessary Information for Treatment Induction in Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma
Key Details
Gender
All
Age Range
1 Year - 18 Years
Study Type
INTERVENTIONAL
Enrollment
850
Start Date
2024-12-26
Completion Date
2039-05
Last Updated
2026-03-03
Healthy Volunteers
No
Interventions
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.
Locations (3)
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