At a glance
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NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma
In Brief
A Phase 2 clinical trial evaluating Prednisone, Vincristine, and 13 other interventions for Lymphoblastic Lymphoma. Completed, enrolled 23 participants across 2 sites.
Detailed Summary
This is a phase II clinical trial using risk-adapted therapy. The treatment is acute lymphoblastic leukemia (ALL)-based therapy, using multi-agent regimens comprising of induction, consolidation, and continuation (maintenance) phases delivered over 24-30 months. Participants will be classified into 3 treatment stratums, based on bone marrow/peripheral blood lymphoma cells involvement at diagnosis and day 8 for T-lymphoblastic lymphoma and bone marrow/peripheral blood lymphoma cells involvement at diagnosis for B-lymphoblastic lymphoma. The Primary Objective of this study is: To improve the outcome of children with lymphoblastic lymphoma (LL) who have minimal disseminated disease (MDD) equal to or more than 1% at diagnosis by using MDD- and minimal residual disease (MRD)- based risk-adapted therapy. The Secondary Objectives of this study are: * To estimate the event-free survival and overall survival of children with lymphoblastic lymphoma who are treated with MDD- or MRD-based risk- directed therapy. * To evaluate the prognostic value of levels of MDD at diagnosis and MRD on day 8 of remission induction.
Study Details
Timeline
Interventions
Given orally (PO).
Given intravenously (IV).
Given IV.
Given intramuscularly (IM) or IV.
Given IM or IV if allergy occurs with the first or second PEG-asparaginase dose.
Given IV.
Given IV.
Given IV or IT.
Given PO.
Given IV.
Given IV, IM or IT.
Given PO.
Given PO or IV.
Given IT.
Given IV.