Trial Summary
What is the purpose of this trial?The goal of this study is to provide sufficient therapy during the time a patients' B-cell Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Leukemia (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.
Eligibility Criteria
This trial is for children and teens aged 1 to nearly 19 with newly diagnosed acute leukemia or lymphoma, including ALL with significant bone marrow involvement, LLy with less than 25% bone marrow blasts, or MPAL. It's not for those who are pregnant/breastfeeding, have had certain cancer treatments already (except limited cases), are ineligible for related studies, can't consent, or have specific pre-existing conditions.Treatment Details
The study tests initial therapy while determining the risk category of B-cell Acute Lymphoblastic Leukemia/Lymphoblastic Leukemia. It involves drugs like Dexamethasone and Vincristine among others. The aim is to gather data on the disease and survival rates while creating a database of genomic/clinical information.
1Treatment groups
Experimental Treatment
Group I: Newly diagnosed ALL, LLy, and MPAL patientsExperimental Treatment6 Interventions
All eligible patients receive the following intervention:
Dexamethasone, Vincristine, Daunorubicin, Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine)
Cytarabine is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Cytosar-U for:
- Acute myeloid leukemia
- Acute lymphocytic leukemia
- Chronic myeloid leukemia
- Meningeal leukemia
🇪🇺 Approved in European Union as Depocyt for:
- Lymphomatous meningitis
🇨🇦 Approved in Canada as Cytosar-U for:
- Acute myeloid leukemia
- Acute lymphocytic leukemia
- Chronic myeloid leukemia
Find a clinic near you
Research locations nearbySelect from list below to view details:
United States, Tennessee St. Jude Children's Research HospitalMemphis, TN
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Who is running the clinical trial?
St. Jude Children's Research HospitalLead Sponsor