Phase II Study of an Association of L-asparaginase-Methotrexate-Dexamethasone for Relapsing and/or Refractory Nasal and Nasal-type NK-T-cell Lymphoma
18 Years
N/A
Both
Lymphoma, Non-Hodgkin
Trial Information
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)
Inclusion Criteria:
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 Criteria:
- Patients who are pregnant or nursing
- Any factor which might limit the patient's ability to provide informed consent
- Liver insufficiency
- Evolutive thrombosis
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Efficacy of chemotherapy
Outcome Time Frame:
3 month, 6 month, 9 month, 12 month, 18 month, 24 month
Safety Issue:
Yes
Principal Investigator
Arnaud JACCARD, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Hospital, Limoges
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
I05009
NCT ID:
NCT00283985
Start Date:
February 2006
Completion Date:
June 2012
Related Keywords:
- Lymphoma, Non-Hodgkin
- NK/T-cell lymphoma
- Lymphoma
- L-asparaginase
- Nasal NK-cell lymphoma
- Nasal-type NK-cell Lymphoma
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, T-Cell
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