Identification of Necessary Information for Treatment Induction in Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma

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.

• Dexamethasone (Drug), also known as Decadron: Per mouth (PO) or intravenously (IV) once on Day 1 and PO or IV divided BID (every 12 hours) days 2-7
• Vincristine (Drug), also known as Vincristine Sulfate, Oncovin: Intravenously (IV) for 1 dose on Day 1 or 2
• Daunorubicin (Drug), also known as Daunomycin: Intravenously (IV) for 1 dose on Day 2 or 3 (T-ALL/ T-LLy/ MPAL only)
• Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine) (Drug), also known as ITMHA: Intrathecal (Age adjusted) for 1 dose on Day 4 or 5 or 6
• Methotrexate (Drug), also known as MTX, Trexall®: Given IT as part of Intrathecal triple therapy.
• Cytarabine (Drug), also known as Cytosine arabinoside, Ara-C: Given IT as part of Intrathecal triple therapy.

Primary outcomes

• Sufficient phenotypic and/or genomic data necessary for therapeutic protocol assignment by Day 8 (completion of INITIALL therapy). [1 week from study entry]: The proportion of patients with sufficient immunophenotypic, genomic, and clinical data to allow determination of eligibility for currently open trials at the enrolling institution.
• Complete data within the INITIALL database [3 months, 1 year, 3, 5 years from study entry]: The proportion of patients with complete data within the INITIALL protocol database as described in the protocol.

Secondary outcomes

• Event Free Survival (EFS) [1, 3, 5 years from study entry]: EFS will be reported as estimates using the Kaplan-Meier method.
• Overall Survival (OS) [1, 3, 5 years from study entry]: OS will be reported as estimates using the Kaplan-Meier method.

Sex: All, ages: 1 Year to 18 Years

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).

Exclusion Criteria:

* Pregnant or breastfeeding
* 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.

• Seth E. Karol, MD, Principal investigator, St. Jude Children's Research Hospital