INITIALL: Identification of Necessary Information for Treatment Induction in Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma
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.
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 tr…
Eligibility
- Age range
- 1–18 years
- Sex
- All
- Healthy volunteers
- No
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). Exclusio…
Interventions
- DrugDexamethasone
Per mouth (PO) or intravenously (IV) once on Day 1 and PO or IV divided BID (every 12 hours) days 2-7
- DrugVincristine
Intravenously (IV) for 1 dose on Day 1 or 2
- DrugDaunorubicin
Intravenously (IV) for 1 dose on Day 2 or 3 (T-ALL/ T-LLy/ MPAL only)
- DrugIntrathecal triple therapy (methotrexate + hydrocortisone + cytarabine)
Intrathecal (Age adjusted) for 1 dose on Day 4 or 5 or 6
- DrugMethotrexate
Given IT as part of Intrathecal triple therapy.
- DrugCytarabine
Given IT as part of Intrathecal triple therapy.
Locations (3)
- Rady Children's HospitalSan Diego, California
- Saint Francis Children's HospitalTulsa, Oklahoma
- St. Jude Children's Research HospitalMemphis, Tennessee