Phase II Study of an Association of L-asparaginase-Methotrexate-Dexamethasone for Relapsing and/or Refractory Nasal and Nasal-type NK-T-cell Lymphoma
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)
Interventional
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
Yes
Arnaud JACCARD, MD
Principal Investigator
University Hospital, Limoges
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
I05009
NCT00283985
February 2006
June 2012
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