Association of L-asparaginase-Methotrexate-Dexamethasone for Nasal and Nasal-type Natural Killer (NK)-T-cell Lymphoma
- Conditions
- Lymphoma, Non-Hodgkin
- Registration Number
- NCT00283985
- Lead Sponsor
- University Hospital, Limoges
- Brief 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Patients with relapsing/refractory T-NK/NK lymphoma:
- Ages 18 years and above
- Patients must have a diagnosis of NK-cell (or T-NK) non-Hodgkin's lymphoma, nasal or nasal-type.
- Stage I, II, III, or IV disease
- Creatinine less than 3 x upper limit of normal (ULN)
- Able to give informed consent
- No prior treatment with asparaginase
Patients with T-NK/NK lymphoma (de novo patients ):
- Ages 18 years and above
- Patients must have a diagnosis of NK-cell (or T-NK) non-Hodgkin's lymphoma, nasal or nasal-type.
- Stage I, II, III, or IV disease
- Creatinine less than 3 x upper limit of normal (ULN)
- Able to give informed consent
- no prior chemotherapy or radiotherapy
- Patients who are pregnant or nursing
- Any factor which might limit the patient's ability to provide informed consent
- Liver insufficiency
- Evolutive thrombosis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Efficacy of chemotherapy 3 month, 6 month, 9 month, 12 month, 18 month, 24 month
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (25)
Service d'Hématologie
🇫🇷Evry, France
Département Maladies du Sang
🇫🇷Angers, France
CH Annecy
🇫🇷Annecy, France
Service de Radiothérapie, Polyclinique Bordeaux Nord
🇫🇷Bordeaux, France
Service d'Hématologie Clinique, Groupe Hospitalier Necker
🇫🇷Paris, France
Service d'Hématologie Clinique, Groupe Hospitalier Pitié-Salpétrière
🇫🇷Paris, France
Service d'Hématologie et de Thérapie Cellulaire - CHU Limoges
🇫🇷Limoges, France
CH Lorient
🇫🇷Lorient, France
Service d'Hématologie Clinique, CHU Dijon
🇫🇷Dijon, France
CHU Lille - Maladies du Sang
🇫🇷Lille, France
Service d'Hématologie Clinique - Hôpital Henri Mondor
🇫🇷Créteil, France
CHU Grenoble-Hématologie Clinique
🇫🇷Grenoble, France
CHU Bordeaux
🇫🇷Bordeaux, France
Département d'Oncologie - Institut Paoli Calmettes
🇫🇷Marseille, France
CHU Lyon - Hématologie Clinique
🇫🇷Lyon, France
CHU Montpellier
🇫🇷Montpellier, France
Hématologie Adulte, Hôpital Necker
🇫🇷Paris, France
CH Lariboisière
🇫🇷Paris, France
Département d'Immuno-Hématologie, Hôpital Saint-Louis
🇫🇷Paris, France
Service d'Immunologie Clinique 2, Hôpital Saint Louis
🇫🇷Paris, France
CHU Toulouse
🇫🇷Toulouse, France
Hôpital St Antoine
🇫🇷Paris, France
Service d'Hématologie Clinique, CHU de Reims
🇫🇷Reims, France
Centre Henri Becquerel-Rouen
🇫🇷Rouen, France
Département Hématologie Clinique
🇫🇷Saint-Etienne, France