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NCT Number: NCT00283985

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

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.

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Key information

Conditions

Lymphoma, Non-Hodgkin Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Extranodal NK-T-Cell Lymphoma, T-Cell Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Département Maladies du Sang, Angers, France

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kidrolase

Drug

6000 u/ m2 IM at J2, J4 and J6 and J8. 3 to 6 cycles.

methotrexate

Drug

3 gr/m2 at J1

Dexamethasone

Drug

40 mg/ per os at J1, J2 and J4.

Erwinase

Drug

In case of allergy to Kidrolase

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

Primary outcomes

  1. Efficacy of chemotherapy

    Time frame: 3 month, 6 month, 9 month, 12 month, 18 month, 24 month

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
Jan 31, 2006
Registry last updated
Feb 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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