The goal of this research study is to evaluate a chemotherapy regiment for the treatment of newly diagnosed Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL) in adolescents and young adults (AYAs).
The names of the study drugs involved in this study are:
* blinatumomab (a type of immunotherapy drug) * cyclophosphamide (a type of chemotherapy drug) * cytarabine (a type of antineoplastic agent) * dexamethasone (a type of synthetic glucocorticoid) * doxorubicin (a type of antineoplastic agent) * etoposide (a type of antineoplastic agent) * mercaptopurine (a type of antineoplastic agent) * methotrexate (a type of chemotherapy drug) * pegaspargase (a type of antineoplastic agent) * vincristine (a type of antineoplastic agent)
Diagnosis should be made by peripheral blood, bone marrow aspirate, bone marrow biopsy, or tissue biopsy demonstrating ≥25% involvement by lymphoblasts, with flow cytometry or immunohistochemistry confirming B-ALL or T-ALL.
Corticosteroids, hydroxyurea, all-trans retinoic acid (ATRA).
IT chemotherapy.
Emergent radiation therapy or leukapheresis for life threatening complications.
None
Parallel
Blinatumomab
DrugA bispecific T-cell engager (BiTE) antibody, single-use vial via intravenous infusion, per standard of care
Oncaspar
DrugA modified enzyme L-asparaginase, single-use vial via intravenous infusion, per standard of care
Cyclophosphamide
DrugAn alkylating agent, single-use vial via intravenous infusion, per standard of care
Cytarabine
DrugAn antineoplastic antimetabolite, multi-dose vial via intrathecal injection (through the spinal space), per standard of care
Dexamethasone
DrugA synthetic glucocorticoid, tablets or single-use vials via orally or intravenous infusion (through the vein), per standard of care
Doxorubicin Hydrochloride
DrugAn anthracycline antibiotic, single-use or multi-dose vials via intravenous infusion, per standard of care
Etoposide
DrugA derivative of podophyllotoxin, multi-dose vial via intravenous infusion, per standard of care
Mercaptopurine
DrugA purine antagonist, tablet via orally, per standard of care
Methotrexate
DrugA folate analogue, multi-dose and single-use vials via intrathecal injection, per standard of care
Vincristine
DrugA vinca alkaloid, single-use vials via intravenous injection, per standard of care
Treatment Completion Rate Through Time Point 3 (TP3)
Treatment completion rate through TP3 is defined as the proportion of Adolescents and Young Adults (AYAs) participants who receive all protocol-specified therapy through TP3, without early discontinuation.
Rate of Treatment-Related Mortality (TRM)
Rate of TRM is defined as the proportion of participants who die due to treatment-related causes.
Rate of Treatment Discontinuation due to Toxicity or Disease
Rate of treatment discontinuation during Induction, Consolidation, and Continuation phases, defined as the proportion of participants who stop protocol-specified therapy due to regimen-related toxicity and/or treatment failure.
Rate of Asparaginase Non-Completion
Rate of asparaginase non-completion is defined as the proportion of participants who did not complete all planned doses of asparaginase per protocol.
Reason of Asparaginase Non-Completion
This outcome summarizes the reasons participants discontinue asparaginase treatment earlier than planned.
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