Identification of Necessary Information for Treatment Induction in Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma
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
Interventions
Dexamethasone
Vincristine
Daunorubicin
Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine)
Methotrexate
Cytarabine
Conditions
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