Association of L-asparaginase-Methotrexate-Dexamethasone for Nasal and Nasal-type Natural Killer (NK)-T-cell Lymphoma
Phase II Study of an Association of L-asparaginase-Methotrexate-Dexamethasone for Relapsing and/or Refractory Nasal and Nasal-type NK-T-cell Lymphoma
1 other identifier
interventional
40
1 country
25
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 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 nasal/nasal 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 nasal/nasal type NK-T-cell lymphoma who have not received asparaginase before.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2006
Longer than P75 for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2006
CompletedFirst Posted
Study publicly available on registry
January 31, 2006
CompletedStudy Start
First participant enrolled
February 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedFebruary 28, 2013
February 1, 2013
6.3 years
January 30, 2006
February 27, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy of chemotherapy
3 month, 6 month, 9 month, 12 month, 18 month, 24 month
Interventions
6000 u/ m2 IM at J2, J4 and J6 and J8. 3 to 6 cycles.
3 gr/m2 at J1
40 mg/ per os at J1, J2 and J4.
In case of allergy to Kidrolase 20000 u/m2 en IM at J2, J4, J6 et J8. 3 to 6 cycles
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients who are pregnant or nursing
- Any factor which might limit the patient's ability to provide informed consent
- Liver insufficiency
- Evolutive thrombosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Département Maladies du Sang
Angers, 49000, France
CH Annecy
Annecy, France
Service de Radiothérapie, Polyclinique Bordeaux Nord
Bordeaux, 33000, France
CHU Bordeaux
Bordeaux, France
Service d'Hématologie Clinique - Hôpital Henri Mondor
Créteil, France
Service d'Hématologie Clinique, CHU Dijon
Dijon, France
Service d'Hématologie
Évry, 91080, France
CHU Grenoble-Hématologie Clinique
Grenoble, France
CHU Lille - Maladies du Sang
Lille, France
Service d'Hématologie et de Thérapie Cellulaire - CHU Limoges
Limoges, France
CH Lorient
Lorient, France
CHU Lyon - Hématologie Clinique
Lyon, France
Département d'Oncologie - Institut Paoli Calmettes
Marseille, France
CHU Montpellier
Montpellier, France
Hématologie Adulte, Hôpital Necker
Paris, 75000, France
Département d'Immuno-Hématologie, Hôpital Saint-Louis
Paris, 75010, France
CH Lariboisière
Paris, France
Hôpital St Antoine
Paris, France
Service d'Hématologie Clinique, Groupe Hospitalier Necker
Paris, France
Service d'Hématologie Clinique, Groupe Hospitalier Pitié-Salpétrière
Paris, France
Service d'Immunologie Clinique 2, Hôpital Saint Louis
Paris, France
Service d'Hématologie Clinique, CHU de Reims
Reims, France
Centre Henri Becquerel-Rouen
Rouen, France
Département Hématologie Clinique
Saint-Etienne, 42000, France
CHU Toulouse
Toulouse, France
Related Publications (1)
Jaccard A, Gachard N, Marin B, Rogez S, Audrain M, Suarez F, Tilly H, Morschhauser F, Thieblemont C, Ysebaert L, Devidas A, Petit B, de Leval L, Gaulard P, Feuillard J, Bordessoule D, Hermine O; GELA and GOELAMS Intergroup. Efficacy of L-asparaginase with methotrexate and dexamethasone (AspaMetDex regimen) in patients with refractory or relapsing extranodal NK/T-cell lymphoma, a phase 2 study. Blood. 2011 Feb 10;117(6):1834-9. doi: 10.1182/blood-2010-09-307454. Epub 2010 Dec 1.
PMID: 21123825DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arnaud JACCARD, MD
University Hospital, Limoges
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2006
First Posted
January 31, 2006
Study Start
February 1, 2006
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
February 28, 2013
Record last verified: 2013-02