NCT00283985

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

Phase II Study of an Association of L-asparaginase-Methotrexate-Dexamethasone for Relapsing and/or Refractory Nasal and Nasal-type NK-T-cell Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University Hospital, Limoges · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Objective: * Determine the overall and complete response rate Secondary Objectives: * To evaluate survival without progression * To evaluate total survival. * To evaluate the tolerance and the side effects of the treatment. * To evaluate the duration and the mode of hospitalization of the patients treated by this therapeutic association. * To constitute a bank of biological samples - serum, tumoral, ADN, ARN to allow prognostic studies implying virus EBV, p53, CD94, C-kit and asparagine synthetase gene in order to better understand the mechanisms of the cancerogenesis of this variety of cytotoxic LNH and to identify the predictive factors of response to the asparaginase. Sampling: For each patient included in the protocol, the following sampling will be carried out with the diagnosis: * Biopsy, * Medullary biopsy * Medullary aspiration * blood: 3 tubes of 7 ml on EDTA and 3 tubs of 7 ml with heparin Treatment: All the patients included will receive three cures separated by 3 weeks (J1, J22, J43): * J1: Methotrexate 3 gr/m2 * J2, J4, J6 and J8: Kidrolase® 6000 u/m2 * J1 with J4: Dexamethasone 40 mg (20 mg if age \> 70 years)

Conditions

• Lymphoma, Non-Hodgkin

Interventions

Type	Name	Description
DRUG	Kidrolase	6000 u/ m2 IM at J2, J4 and J6 and J8. 3 to 6 cycles.
DRUG	Methotrexate	3 gr/m2 at J1
DRUG	Dexamethasone	40 mg/ per os at J1, J2 and J4.
DRUG	Erwinase	In case of allergy to Kidrolase 20000 u/m2 en IM at J2, J4, J6 et J8. 3 to 6 cycles

Timeline

• Start date: 2006-02-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2006-01-31
• Last updated: 2013-02-28

Locations

25 sites across 1 country: France