drugset / Trial / NCT01451515

NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma

NCT01451515

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2012-05-25
Primary completion
2021-05-08
Completion
2022-05-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Asparaginase Erwinia chrysanthemi Protein / enzyme biologic Intramuscular
Subject Clofarabine Other / unclassified Intravenous
Subject Cyclophosphamide Other / unclassified Intravenous
Subject Cytarabine Small molecule Intravenous
Subject Daunorubicin Small molecule Intravenous
Subject Dexamethasone Small molecule Oral
Subject Doxorubicin Other / unclassified Intravenous
Subject Etoposide Small molecule Intravenous
Subject Hydrocortisone Other / unclassified Intrathecal
Subject MERCAPTOPURINE ANHYDROUS Small molecule Oral
Subject Methotrexate Small molecule Intravenous
Subject Pegaspargase Protein / enzyme biologic Intramuscular
Subject Prednisone Other / unclassified Oral
Subject Thioguanine Small molecule Oral
Subject Vincristine Small molecule Intravenous