Phase II Study of an Association of L-asparaginase-Methotrexate-Dexamethasone for Relapsing and/or Refractory Nasal and Nasal-type NK-T-cell Lymphoma
- Determine the overall and complete response rate
- 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.
For each patient included in the protocol, the following sampling will be carried out with
- Medullary biopsy
- Medullary aspiration
- blood: 3 tubes of 7 ml on EDTA and 3 tubs of 7 ml with heparin
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)
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Efficacy of chemotherapy
3 month, 6 month, 9 month, 12 month, 18 month, 24 month
Arnaud JACCARD, MD
University Hospital, Limoges
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)