Lymphoma, Non-HodgkinPhase 2NCT00553943
Phase II Study to Evaluate the Combination of Rituximab and DepoCyte® in the C5R Chemotherapy Protocol in Patients Between the Ages of 18 and 60 Years With Primary Cerebral Non-Hodgkin Lymphoma and Systemic Diffuse Large B-cell Lymphoma With Neuromeningeal Invasion at Diagnosis
A Phase 2 study testing Rituximab and Cytarabine in people with Lymphoma, Non-Hodgkin and Diffuse Large B-cell Lymphoma, run by Lymphoma Study Association at 46 sites in 2 countries.
Trial summary
The purpose of this study is to measure the rate of complete response (CR and UCR) at the end of a course of immuno-chemotherapy: before cerebral radiotherapy for PCL after the course of immuno-chemotherapy for aggressive lymphomas with neuromeningeal involvement Toxicity of the protocol Overall survival Survival… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lymphoma, Non-Hodgkin, Diffuse Large B-cell Lymphoma
- What is being tested?
- Rituximab and Cytarabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 46 sitesin 2 countries
- Study dates
- Jul 2007to Mar 2017
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Primary cerebral or oculocerebral NHL not previously treated with chemotherapy or radiotherapy and diffuse large B-cell lymphomas, with cerebral and / or neuromeningeal involvement at diagnosis.
- Diagnosis proved by histological or cytological examination of cerebral specimens, CSF or vitreous humour.
- Diffuse large cell CD20+ lymphoma.
- Men or women between the ages of 18 and 60 years.
- Presence of a measurable target to evaluate response.
- Negative serological tests for HIV, hepatitis B (except in cases of vaccination), hepatitis C.
- Life-expectancy ≥ 3 months
- Patient having given written consent to participate in this study.
Who cannot join
- CD20- lymphoma.
- History of indolent lymphoma, treated or untreated.
- Contraindication for one of the products used in polychemotherapy.
- Known hypersensitivity to mouse antibodies.
- Absence of measurable target to evaluate response.
- History of cancer in the 5 years prior to inclusion except for cutaneous basocellular carcinomas and non-invasive carcinomas of the neck of the uterus.
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- Cardiac contraindication to treatment with anthracyclines or to hyperhydration:
- SEVERE DISTURBANCE OF HEART RHYTHM VENTRICULAR EJECTION FRACTION BELOW 50% HISTORY OF RECENT MYOCARDIAL INFARCTION
- Previously known severe renal insufficiency and/or creatinaemia >150 µM/L (apart from invasion of the kidneys by the lymphoma).
- Total bilirubin >30 µmol/L, ASAT, ALAT >2.5 times the upper normal value (apart from invasion of the liver by the lymphoma).
- Insufficient medullary reserve: PNL < 1 G/L and platelets <100 G/L (apart from invasion of the medulla by the lymphoma).
- History of organ transplantation or other causes of severe immunosuppression.
- Pregnant woman.
- Patient incapable of keeping to regular monitoring.
Trial locations and contacts
46 sites in 2 countries.
46 sites in 2 countries
France35 sites
CH d'Annecy
Annecy, F-74011
Centre Hospitalier d'Avignon
Avignon, F-84902
Hôpital de Bayonne
Bayonne, F-64100
Hôpital d'Avicenne
Bobigny, F-93009
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, F-33300
CH de Brive
Brive-la-Gaillarde, F-19190
CHU Clemenceau
Caen, F-14033
Centre Francois Baclesse
Caen, F-14076
CH de Chambery
Chambéry, F-73011
CH de Chartres
Chartres, F-28018
Hôpital Gilles de Corbeil
Corbeil-Essonnes, F-91108
Hôpital Henri Mondor
Créteil, F-94010
CHU Le Bocage
Dijon, F-21034
Centre Hospitalier de Dunkerque
Dunkirk, F-59385
Hôpital Saint Louis
La Rochelle, F-17019
Hôpital Andre Mignot
Le Chesnay, F-78157
Hôpital Bicêtre
Le Kremlin-Bicêtre, F-94270
CHU de Lens
Lens, F-62307
Hopital Saint Vincent de Paul
Lille, F-59020
CHU Claude Huriez
Lille, F-59037
Hôpital Dupuytren
Limoges, F-87000
Centre Leon Berard
Lyon, F-69373
Hôpital des Chanaux
Mâcon, F-71018
CH de Meaux
Meaux, F-77100
Hôpital Bon Secours
Metz, F-57038
Hôpital Emile Muller
Mulhouse, F-68070
Centre Antoine Lacassagne
Nice, F-06054
Hôpital Saint Louis
Paris, F-75475
Hôpital Necker
Paris, F-75743
Centre Hospitalier de Perpigan
Perpignan, F-66046
Centre Hospitalier Lyon Sud
Pierre-Bénite, F-69495
Centre Henri Becquerel
Rouen, F-76038
CH de St Germain
Saint-Germain-en-Laye, F-78108
Hôpital Purpan
Toulouse, F-31000
Hopital Brabois
Vandœuvre-lès-Nancy
Belgium11 sites
ZNA Stuivenberg
Antwerp, 2060
Hôpital Saint Joseph
Arlon, Bruges
A. Z. Sint-Jan
Bruges, 8000
UCL- Saint Luc
Brussels, 1200
CH Notre Dame
Charleroi, 6000
AZ VUB
Jette, 1090
CHR de la Citadelle
Liège, 4000
CHU Charleroi-Vésale
Montigny-le-Tilleul, 6110
Clinique Saint Pierre
Ottignies, 1340
Heilig Hart Ziekenhuis
Roeselare, 8800
UCL - Mont-Godinne
Yvoir, 5530
About this study
Official title: Prospective Multicentre Phase II Study to Evaluate the Combination of Rituximab and DepoCyte® by Intrathecal Injection in the C5R Chemotherapy Protocol in Patients Between the Ages of 18 and 60 Years With Primary Cerebral Non-Hodgkin Lymphoma and Systemic Diffuse Large B-cell Lymphoma With Neuromeningeal Invasion at Diagnosis
The purpose of this study is to measure the rate of complete response (CR and UCR) at the end of a course of immuno-chemotherapy:
- before cerebral radiotherapy for PCL
- after the course of immuno-chemotherapy for aggressive lymphomas with neuromeningeal involvement Toxicity of the protocol Overall survival Survival without relapse Long-term incidence of neurocognitive toxicity
- Being tested
- Rituximab, Cytarabine
- Keywords
- lymphoma, cerebral lymphoma, central nervous system, cytarabine, rituximab, Diffuse large B-cell lymphomas, with cerebral or neuromeningeal involvement
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Dendritic Cell Sarcoma, Interdigitating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
375 mg/m2 D1
CytarabineDrug
50 mg D3
| Study group | Role | What they receive |
|---|---|---|
| Rituximab + Cytarabine | Experimental | Not described Receives: Drug: Rituximab; Drug: Cytarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to treatment (CR/PR)
Measured: End of treatment - 5 months
Secondary outcomes (1)
Toxicity, Overall survival, Time to progression
Measured: End of study - 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2007 (estimated)
- Study startJul 2007
- Primary completionJun 2012
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lymphoma Study Association
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Herve Ghesquieres, MD, Study chair, LYmphoma Study Association (LYSA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00553943
- Sponsor's protocol ID
- R-C5R 2006
- Status last verified
- Aug 2018
- First submitted
- 5 Nov 2007
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicentre Phase II Study to Evaluate the Combination of Rituximab and DepoCyte® by Intrathecal Injection in the C5R Chemotherapy Protocol in Patients Between the Ages of 18 and 60 Years With Primary Cerebral Non-Hodgkin Lymphoma and Systemic Diffuse Large B-cell Lymphoma With Neuromeningeal Invasion at Diagnosis
- ClinicalTrials.gov ID
- NCT00553943
- Acronym / sponsor ID
- R-C5R 2006
- Keywords
- lymphoma, cerebral lymphoma, central nervous system, cytarabine, rituximab, Diffuse large B-cell lymphomas, with cerebral or neuromeningeal involvement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Lymphoma Study AssociationUniversity, hospital or other
- Study start
- Jul 2007 (actual)
- Primary completion
- Jun 2012 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 6 Nov 2007 (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.
The purpose of this study is to measure the rate of complete response (CR and UCR) at the end of a course of immuno-chemotherapy:
- before cerebral radiotherapy for PCL
- after the course of immuno-chemotherapy for aggressive lymphomas with neuromeningeal involvement Toxicity of the protocol Overall survival Survival without relapse Long-term incidence of neurocognitive toxicity
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rituximab + Cytarabine | Experimental | Drug: Rituximab, Drug: Cytarabine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Primary cerebral or oculocerebral NHL not previously treated with chemotherapy or radiotherapy and diffuse large B-cell lymphomas, with cerebral and / or neuromeningeal involvement at diagnosis.
- Diagnosis proved by histological or cytological examination of cerebral specimens, CSF or vitreous humour.
- Diffuse large cell CD20+ lymphoma.
- Men or women between the ages of 18 and 60 years.
- Presence of a measurable target to evaluate response.
Key exclusion criteria (14 listed)
- CD20- lymphoma.
- History of indolent lymphoma, treated or untreated.
- Contraindication for one of the products used in polychemotherapy.
- Known hypersensitivity to mouse antibodies.
- Absence of measurable target to evaluate response.
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 |
|---|---|---|
| Rituximab375 mg/m2 D1 | Drug | Rituximab + Cytarabine |
| Cytarabine50 mg D3 | Drug | Rituximab + Cytarabine |
Primary outcome
Response to treatment (CR/PR)
Time frame: End of treatment - 5 months
1 secondary outcome
Toxicity, Overall survival, Time to progression
Time frame: End of study - 5 years
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 23 Aug 2018.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Herve Ghesquieres, MD study chair
LYmphoma Study Association (LYSA)
46 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rituximab and Cytarabine in people with Lymphoma, Non-Hodgkin and Diffuse Large B-cell Lymphoma, run by Lymphoma Study Association at 46 sites in 2 countries.
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 8 inclusion and 14 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 23 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in France, Belgium. 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?
Response to treatment (CR/PR) (time frame: End of treatment - 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Aug 2018.