2상모집 중

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
128
시작일
2025-01-23
완료(예정)
2034-05-01

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