NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |