Phase 2 Study of Recombinant Erwinia Asparaginase with Pediatric-Inspired Chemotherapy for High-Risk Adults Aged 18 to 54 with Newly Diagnosed Philadelphia-Negative Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

What this Trial Is About

Researchers are studying high-risk adults aged 18 to 54 with newly diagnosed acute lymphoblastic leukemia ALL or lymphoblastic lymphoma LBL that is Philadelphia chromosome negative. The trial evaluates the safety, side effects, and effectiveness of asparaginase Erwinia chrysanthemi combined with chemotherapy during initial treatment. This phase II trial aims to understand how this enzyme-based drug, which may stop cancer growth, works when given with other chemotherapy drugs in patients who cannot take asparaginase from E. coli. Participants receive induction therapy including drugs like cytarabine, dexamethasone, vincristine, daunorubicin, methotrexate, rituximab for CD20 positive patients, and asparaginase Erwinia chrysanthemi given intramuscularly on specific days over four weeks. Those with certain disease features may continue with extended induction therapy. Afterwards, consolidation therapy lasts about eight weeks with cyclophosphamide, cytarabine, mercaptopurine, vincristine, methotrexate, rituximab if CD20 positive, and possibly additional doses of asparaginase Erwinia chrysanthemi. Treatment adjusts based on disease progression and tolerance. During the study, patients undergo various tests including blood samples, bone marrow biopsies, lumbar punctures, echocardiograms, and CT or PETCT scans. Researchers closely monitor safety by tracking adverse events and specific liver-related problems, and measure treatment response including remission rates and minimal residual disease. Follow-up occurs 30 days after treatment ends to assess ongoing safety and outcomes.

Asparaginase Erwinia Chrysanthemi With Chemotherapy for the Treatment of High-Risk Adults With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma