NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma
Status:
Active, not recruiting
Trial end date:
2022-05-01
Target enrollment:
Participant gender:
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.