Lymphoma, Non-HodgkinPhase 2NCT00283985
Association of L-asparaginase-Methotrexate-Dexamethasone for Nasal and Nasal-type Natural Killer (NK)-T-cell Lymphoma
A Phase 2 study testing Kidrolase, Methotrexate and Dexamethasone in people with Lymphoma, Non-Hodgkin, run by University Hospital, Limoges at 25 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin
- What is being tested?
- Kidrolase, Methotrexate and Dexamethasone
- How many people
- 40 participants
- Where
- 25 sitesFrance
- Study dates
- Feb 2006to Jun 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- Patients who are pregnant or nursing
- Any factor which might limit the patient's ability to provide informed consent
- Liver insufficiency
- Evolutive thrombosis
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
France25 sites
Département Maladies du Sang
Angers, 49000
CH Annecy
Annecy
Service de Radiothérapie, Polyclinique Bordeaux Nord
Bordeaux, 33000
CHU Bordeaux
Bordeaux
Service d'Hématologie Clinique - Hôpital Henri Mondor
Créteil
Service d'Hématologie Clinique, CHU Dijon
Dijon
Service d'Hématologie
Évry, 91080
CHU Grenoble-Hématologie Clinique
Grenoble
CHU Lille - Maladies du Sang
Lille
Service d'Hématologie et de Thérapie Cellulaire - CHU Limoges
Limoges
CH Lorient
Lorient
CHU Lyon - Hématologie Clinique
Lyon
Département d'Oncologie - Institut Paoli Calmettes
Marseille
CHU Montpellier
Montpellier
Hématologie Adulte, Hôpital Necker
Paris, 75000
Département d'Immuno-Hématologie, Hôpital Saint-Louis
Paris, 75010
CH Lariboisière
Paris
Hôpital St Antoine
Paris
Service d'Hématologie Clinique, Groupe Hospitalier Necker
Paris
Service d'Hématologie Clinique, Groupe Hospitalier Pitié-Salpétrière
Paris
Service d'Immunologie Clinique 2, Hôpital Saint Louis
Paris
Service d'Hématologie Clinique, CHU de Reims
Reims
Centre Henri Becquerel-Rouen
Rouen
Département Hématologie Clinique
Saint-Etienne, 42000
CHU Toulouse
Toulouse
About this study
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
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.
Read the 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 gr/m2
- J2, J4, J6 and J8: Kidrolase® 6000 u/m2
- J1 with J4: Dexamethasone 40 mg (20 mg if age > 70 years)
- Conditions
- Lymphoma, Non-Hodgkin
- Being tested
- Kidrolase, Methotrexate, Dexamethasone, Erwinase
- Keywords
- NK/T-cell lymphoma, Lymphoma, L-asparaginase, Nasal NK-cell lymphoma, Nasal-type NK-cell Lymphoma
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, Extranodal NK-T-Cell, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KidrolaseDrug
6000 u/ m2 IM at J2, J4 and J6 and J8. 3 to 6 cycles.
MethotrexateDrug
3 gr/m2 at J1
DexamethasoneDrug
40 mg/ per os at J1, J2 and J4.
ErwinaseDrug
In case of allergy to Kidrolase
20000 u/m2 en IM at J2, J4, J6 et J8. 3 to 6 cycles
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of chemotherapy
Measured: 3 month, 6 month, 9 month, 12 month, 18 month, 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2006 (estimated)
- Study startFeb 2006
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud JACCARD, MD, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00283985
- Sponsor's protocol ID
- I05009
- Status last verified
- Feb 2013
- First submitted
- 30 Jan 2006
- Last updated
- 28 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21123825
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00283985
- Acronym / sponsor ID
- I05009
- Conditions
- Lymphoma, Non-Hodgkin
- Keywords
- NK/T-cell lymphoma, Lymphoma, L-asparaginase, Nasal NK-cell lymphoma, Nasal-type NK-cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 31 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 gr/m2
- J2, J4, J6 and J8: Kidrolase® 6000 u/m2
- J1 with J4: Dexamethasone 40 mg (20 mg if age > 70 years)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (4 listed)
- Patients who are pregnant or nursing
- Any factor which might limit the patient's ability to provide informed consent
- Liver insufficiency
- Evolutive thrombosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kidrolase6000 u/ m2 IM at J2, J4 and J6 and J8. 3 to 6 cycles. | Drug | – |
| Methotrexate3 gr/m2 at J1 | Drug | – |
| Dexamethasone40 mg/ per os at J1, J2 and J4. | Drug | – |
| ErwinaseIn case of allergy to Kidrolase 20000 u/m2 en IM at J2, J4, J6 et J8. 3 to 6 cycles | Drug | – |
Primary outcome
Efficacy of chemotherapy
Time frame: 3 month, 6 month, 9 month, 12 month, 18 month, 24 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2013.
- Derived from this study: PubMed 21123825Jaccard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnaud JACCARD, MD principal investigator
University Hospital, Limoges
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Kidrolase, Methotrexate and Dexamethasone in people with Lymphoma, Non-Hodgkin, run by University Hospital, Limoges at 25 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of chemotherapy (time frame: 3 month, 6 month, 9 month, 12 month, 18 month, 24 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00283985, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2013.