Status:
COMPLETED
Association of L-asparaginase-Methotrexate-Dexamethasone for Nasal and Nasal-type Natural Killer (NK)-T-cell Lymphoma
Lead Sponsor:
University Hospital, Limoges
Conditions:
Lymphoma, Non-Hodgkin
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 treatme...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Patients who are pregnant or nursing
- Any factor which might limit the patient's ability to provide informed consent
- Liver insufficiency
- Evolutive thrombosis
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00283985
Start Date
February 1 2006
End Date
June 1 2012
Last Update
February 28 2013
Active Locations (25)
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1
Département Maladies du Sang
Angers, France, 49000
2
CH Annecy
Annecy, France
3
Service de Radiothérapie, Polyclinique Bordeaux Nord
Bordeaux, France, 33000
4
CHU Bordeaux
Bordeaux, France