Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00283985
Status:
COMPLETED
Last Update Posted:
2013-02-28
First Post:
2006-01-30
Brief Title:
Association of L-asparaginase-Methotrexate-Dexamethasone for Nasal and Nasal-type Natural Killer NK-T-cell Lymphoma
Sponsor:
University Hospital Limoges
Organization:
University Hospital Limoges
Study Overview
Official Title:
Phase II Study of an Association of L-asparaginase-Methotrexate-Dexamethasone for Relapsing andor Refractory Nasal and Nasal-type NK-T-cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Nasalnasal type NK-T-cell lymphoma is a rare and severe type of non-Hodgkins 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 nasalnasal 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 nasalnasal type NK-T-cell lymphoma who have not received asparaginase before
The investigators propose a phase II protocol for patients with refractory or relapsing nasalnasal 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 nasalnasal 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 grm2
J2 J4 J6 and J8 Kidrolase 6000 um2
J1 with J4 Dexamethasone 40 mg 20 mg if age 70 years
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 grm2
J2 J4 J6 and J8 Kidrolase 6000 um2
J1 with J4 Dexamethasone 40 mg 20 mg if age 70 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None