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Association of L-asparaginase-Methotrexate-Dexamethasone for Nasal and Nasal-type Natural Killer (NK)-T-cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00283985
Recruitment Status : Completed
First Posted : January 31, 2006
Last Update Posted : February 28, 2013
Information provided by (Responsible Party):
University Hospital, Limoges

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.

Condition or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin Drug: Kidrolase Drug: Methotrexate Drug: Dexamethasone Drug: Erwinase Phase 2

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.


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


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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of an Association of L-asparaginase-Methotrexate-Dexamethasone for Relapsing and/or Refractory Nasal and Nasal-type NK-T-cell Lymphoma
Study Start Date : February 2006
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Intervention Details:
  • Drug: Kidrolase
    6000 u/ m2 IM at J2, J4 and J6 and J8. 3 to 6 cycles.
  • Drug: Methotrexate
    3 gr/m2 at J1
  • Drug: Dexamethasone
    40 mg/ per os at J1, J2 and J4.
  • Drug: Erwinase

    In case of allergy to Kidrolase

    20000 u/m2 en IM at J2, J4, J6 et J8. 3 to 6 cycles

Primary Outcome Measures :
  1. Efficacy of chemotherapy [ Time Frame: 3 month, 6 month, 9 month, 12 month, 18 month, 24 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00283985

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Département Maladies du Sang
Angers, France, 49000
CH Annecy
Annecy, France
Service de Radiothérapie, Polyclinique Bordeaux Nord
Bordeaux, France, 33000
CHU Bordeaux
Bordeaux, France
Service d'Hématologie Clinique - Hôpital Henri Mondor
Créteil, France
Service d'Hématologie Clinique, CHU Dijon
Dijon, France
Service d'Hématologie
Evry, France, 91080
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, France, 75000
Département d'Immuno-Hématologie, Hôpital Saint-Louis
Paris, France, 75010
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, France, 42000
CHU Toulouse
Toulouse, France
Sponsors and Collaborators
University Hospital, Limoges
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Principal Investigator: Arnaud JACCARD, MD University Hospital, Limoges

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University Hospital, Limoges Identifier: NCT00283985     History of Changes
Other Study ID Numbers: I05009
First Posted: January 31, 2006    Key Record Dates
Last Update Posted: February 28, 2013
Last Verified: February 2013

Keywords provided by University Hospital, Limoges:
NK/T-cell lymphoma
Nasal NK-cell lymphoma
Nasal-type NK-cell Lymphoma

Additional relevant MeSH terms:
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Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Abortifacient Agents, Nonsteroidal
Abortifacient Agents