drugset / Trial / NCT00283985

Association of L-asparaginase-Methotrexate-Dexamethasone for Nasal and Nasal-type Natural Killer (NK)-T-cell Lymphoma

NCT00283985

Phase 2 Completed 40 enrolled University Hospital, Limoges
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Nasal/nasal type NK-T-cell lymphoma is a rare and severe type of non-Hodgkin's lymphoma (NHL) more frequent in Asia than in western countries. When localised, radiotherapy seems to be the best treatment. When radiotherapy cannot be used because of dissemination or relapse, chemotherapy protocols used for other types of NHL give poor results and survival is poor. Recently papers from China and Japan reported the efficacy of a drug: l-asparaginase, usually used to treat acute lymphoblastic leukemia. In vitro a selective apoptosis of NK-cell tumours by l-asparaginase was shown on tumour cell lines and samples. The investigators propose a phase II protocol for patients with refractory or relapsing nasal/nasal type NK-T-cell lymphoma using a regimen combining l-asparaginase, methotrexate and dexamethasone. Biological studies will be conducted trying to find factors which could predict responses to this chemotherapy. Since january 2009, the study concerns all patients with nasal/nasal type NK-T-cell lymphoma who have not received asparaginase before.

Timeline

Start
2006-02
Primary completion
2012-06
Completion
2012-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Asparaginase Erwinia chrysanthemi Protein / enzyme biologic 20000 unknown Intramuscular
Subject Dexamethasone Small molecule 20 mg Oral
Subject Dexamethasone Small molecule 40 mg Oral
Subject Methotrexate Small molecule 3000 mg/m2
Subject asparaginase Protein / enzyme biologic 6000 unknown Intramuscular

Indications