Phase II Trial of Hyper-CVAD Chemotherapy Combined with Nelarabine for Newly Diagnosed T-cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of combining chemotherapy drugs with nelarabine in treating patients who have not previously received treatment for T-cell acute lymphoblastic leukemia ALL or T-cell lymphoblastic lymphoma. This phase II trial aims to measure complete remission rates, progression-free survival, and overall survival, while also assessing the safety of adding pegaspargase and venetoclax to the treatment regimen. The treatment involves multiple courses alternating between hyper-CVAD chemotherapy cyclophosphamide, vincristine, doxorubicin, dexamethasone and methotrexatecytarabine. Venetoclax is taken orally during each course. Nelarabine and pegaspargase are given intravenously during specific courses, with intensification phases including these drugs as well. Maintenance therapy with mercaptopurine, vincristine, methotrexate, prednisone, and venetoclax continues for up to 30 months, provided there is no disease progression or unacceptable side effects. Participants undergo regular treatment cycles every 21 to 35 days depending on the course, with follow-up visits every 3 to 6 months after completing study treatment. Researchers monitor remission duration, survival rates, and disease progression while tracking any side effects. The total involvement may last several years due to the long maintenance phase and extended follow-up care to evaluate long-term outcomes and safety.

Combination Chemotherapy and Nelarabine in Treating Patients With T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma