Dana-Farber Cancer Institute
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)
This Phase 2, single-arm research study is to evaluate a chemotherapy regiment the treatment of newly diagnosed Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL) in adolescents and young adults (AYAs). The U.S. Food and Drug Administration (FDA) has approved all of the drugs of treatment being studied but the investigators of this research study want to understand more about the safety and effectiveness of the chemotherapy regimen in adolescents and young adults with newly diagnosed Philadelphia chromosome-negative ALL. The research study procedures include screening for el…
Inclusion Criteria: 3.1.1Confirmed diagnosis of Philadelphia chromosome-negative acute lymphoblastic leukemia. * 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. o Participants with B-cell and T-cell lymphoblastic lymphoma are eligible regardless of bone marrow involvement Participants with mixed phenotype acute leukemia (MPAL) ARE eligible, if an ALL regimen is felt to be most appropriate treatment. * Participants w…
A bispecific T-cell engager (BiTE) antibody, single-use vial via intravenous infusion, per standard of care
A modified enzyme L-asparaginase, single-use vial via intravenous infusion, per standard of care
An alkylating agent, single-use vial via intravenous infusion, per standard of care
An antineoplastic antimetabolite, multi-dose vial via intrathecal injection (through the spinal space), per standard of care
A synthetic glucocorticoid, tablets or single-use vials via orally or intravenous infusion (through the vein), per standard of care
An anthracycline antibiotic, single-use or multi-dose vials via intravenous infusion, per standard of care
A derivative of podophyllotoxin, multi-dose vial via intravenous infusion, per standard of care
A purine antagonist, tablet via orally, per standard of care
A folate analogue, multi-dose and single-use vials via intrathecal injection, per standard of care
A vinca alkaloid, single-use vials via intravenous injection, per standard of care
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