Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma
연구 개요
This is a Phase II clinical trial testing the use of two antigen-directed therapies, inotuzumab and blinatumomab, as part of induction therapy for children and young adults with newly diagnosed B-cell precursor acute lymphoblastic leukemia and lymphoma. Primary Objective * To assess if the flow-cytometry assessed MRD-negative remission rate following an immunotherapy-based Induction in NCI-high risk patients without favorable genetic features is higher than the results of similar patients treated on AALL1131. Secondary Objectives * To compare flow-cytometry assessed MRD-negative rates at the end of Induction for patients treated with this therapy compared to similar patients treated on TOT17. * To compare the rate of significant toxicities in patients treated with this therapy to those treated with standard-risk therapy on TOT17. * To assess the event free and overall survival of patients treated with this therapy.
- 스폰서
- 협력: 암젠, 화이자
- 적응증
- Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma
- 중재
- Dexamethasone, Vincristine, Inotuzumab, Blinatumomab, Dasatinib, IT MHA, Cyclophosphamide, Cytarabine, Methotrexate, 6-Mercaptopurine, Calaspargase, Daunorubicin, Thioguanine
- 목표 등록
- 128명
- 시작일
- 2025-01-23
- 완료(예정)
- 2034-05-01
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