Non Previously Treated CD20+ Diffuse Large B-cell LymphomaPhase 2NCT01195714
Study of Mini-Chop Plus Ofatumumab To Treat Cd 20+ Diffuse Large B-Cell Lymphoma In Patients Aged Over 80 Years
A Phase 2 study testing Ofatumumab in people with Non Previously Treated CD20+ Diffuse Large B-cell Lymphoma, run by The Lymphoma Academic Research Organisation at 84 sites in 2 countries.
Trial summary
This study is a multicentric, phase II, open-label, non-randomized trial evaluating the efficacy of O-miniCHOP in patients aged over 80 years with non previously treated CD20+ diffuse large B-cell lymphoma (age-adjusted IPI=0 to3), stage I, II, III or IV with a performance status ECOG from 0 to 4. Read more about this study
- Who is it for?
- Ages 81 years and older
- Conditions the study is for
- Non Previously Treated CD20+ Diffuse Large B-cell Lymphoma
- What is being tested?
- Ofatumumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 84 sitesin 2 countries
- Study dates
- May 2010to Apr 2014
- 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 81 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patient with histologically proven CD20+ diffuse large B-cell lymphoma (DLBCL) (WHO classification 2008) including clinical subtypes (primitive mediastinal, intravascular, etc.) May also be included : de Novo Transformed DLBCL from low grade lymphoma (Follicular, other...) and DLBCL associated with some small cell infiltration in bone marrow
- Or CD20+ B-cell lymphoma, with intermediate features between DLBCL and Burkitt or with intermediate features between DLBCL and classical Hodgkin lymphoma
- Or CD20+ Follicular lymphoma grade 3B
- Or CD20+ Aggressive B-cell lymphoma unclassifiable Aged over 80 years. Ann Arbor stage I, II, III or IV. All aaIPI Patient non previously treated. All ECOG performance status With a minimum life expectancy of 3 months. Negative HIV, HBV and HCV serologies test < 4 weeks (except after vaccination). Patient able to give his consent and having previously signed a written informed consent.
- Patient affiliated to social security system, if applicable
Who cannot join
- Any other histological type of lymphoma, Burkitt included. Any history of treated or non-treated small-B cell lymphoma. Central nervous system or meningeal involvement by lymphoma. Contra-indication to any drug contained in the chemotherapy regimens. Any serious active disease (according to the investigator's decision). Poor renal function (creatinin level>150µmol/l), poor hepatic function (total bilirubin level>30mmol/l, transaminases>2.5 maximum normal level) unless these abnormalities are related to the lymphoma.
- Poor bone marrow reserve as defined by neutrophils <1.5 G/l or platelets <100 G/l, unless related to bone marrow infiltration.
- Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma. Patients previously diagnosed with prostate cancer are eligible if (1) their disease was T1-T2a, N0, M0, with a Gleason score <7, and a prostate specific antigen (PSA) <10 ng/mL prior to initial therapy, (2) they had definitive curative therapy (ie, prostatectomy or radiotherapy) >2 years before Day 1 of Cycle 1, and (3) at a minimum 2 years following therapy they had no clinical evidence of prostate cancer, and their PSA was undetectable if they underwent prostatectomy or <1 ng/mL if they did not undergo prostatectomy.
- Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
- Prior treatment with anti-CD20 monoclonal antibody or alemtuzumab within 3 months prior to start of therapy Adult patient under tutelage.
Trial locations and contacts
84 sites in 2 countries.
84 sites in 2 countries
France67 sites
Ch Du Pays D'Aix
Aix-en-Provence, 13616
Ch Antibes
Antibes, 06606
Ch Henri Duffaut
Avignon, 84902
Hopital de Bayonne
Bayonne, 64100
Hopital Avicenne
Bobigny, 93009
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33300
Ch Du Dr Duchenne
Boulogne-sur-Mer, 62321
Ch de Bour En Bresse
Bourg-en-Bresse, 01000
Chu de Brive
Brive-la-Gaillarde, 19190
Chu Cote de Nacre
Caen, 14033
Centre Henri Baclesse
Caen, 14076
Ch de Cannes
Cannes, 06401
Hopital de Chalon
Chalon-sur-Saône, 71100
Ch Chambery
Chambéry, 73011
Ch de Chartres - Hopital Louis Pasteur
Chartres, 28018
Hopital Antoine Beclere
Clamart, 92140
Hopital D'Instruction Des Armees Percy
Clamart, 92141
Hopital Pasteur
Colmar, 68024
Ch Compiege
Compiègne, 60321
Ch Sud Francilien
Corbeil-Essonnes, 91106
Hopital Henri Mondor
Créteil, 94010
Chu Le Bocage
Dijon, 21034
Ch de Dunkerque
Dunkirk, 59385
Ch Dunkerque
Dunkirk, 59385
Ch Frejus St Raphael
Fréjus, 83608
CH GERET
Guéret, 23000
Hopital Saint Louis
La Rochelle, 17019
Hopital Andre Mignot
Le Chesnay, 78157
Hopital Bicetre
Le Kremlin-Bicêtre, 94275
Ch de Meulan
Les Mureaux, 78250
Hopital St Vincent de Paul
Lille, 59020
Chu Claude Hurriez
Lille, 59037
Chu Dupuytren
Limoges, 87042
Centre Leon Berard
Lyon, 69373
Hopital Des Chanaux
Mâcon, 71018
Chu Hopital Nord
Marseille, 13015
Institut Paoli Calmette
Marseille, 13723
Chu de Meaux
Meaux, 77104
Chu Marc Jacquet
Melun, 77011
Hopital Bon Secours
Metz, 57019
Crlc Val D'Aurelle - Paul Lamarque
Montpellier, 34298
Centre Azureen de Cancerologie
Mougins, 06250
Hopital Americain de Paris
Neuilly-sur-Seine, 92200
Centre Antoine Lacassagne
Nice, 06003
Hopital St Antoine
Paris, 75012
Hotel Dieu
Paris, 75181
Hopital St Louis
Paris, 75475
Hopital de La Pitie Salpetriere
Paris, 75651
Institut Curie
Paris, 75674
Hopital Necker
Paris, 75743
Ch Marechal Joffre
Perpignan, 66046
Chu Lyon Sud
Pierre-Bénite, 69495
Chu de Poitiers - Hopital de Miletrie
Poitiers, 86021
Ch Rene Dubos
Pontoise, 95301
Ch Annecy
Pringy, 74370
Chu Robert Debre
Reims, 51092
Ch de Roubaix - Hopital Victor Provo
Roubaix, 59100
Clinique Mathilde
Rouen, 76000
Centre Henri Becquerel
Rouen, 76038
Centre Rene Hugenin
Saint-Cloud, 92210
Ch de Saint Germain
Saint-Germain-en-Laye, 78105
Hopital Font Pre
Toulon, 83056
Chu de Toulouse
Toulouse, 31059
Ch de Troyes
Troyes, 10003
Hopital de Valence
Valence, 26953
Chu Brabois
Vandœuvre-lès-Nancy, 54511
Institut Gustave Roussy
Villejuif, 94805
Belgium17 sites
Zna Stuivenberg
Antwerp, 2060
RHMS
Baudour
Az Sint Jan Av
Bruges, 8000
Institut Jules Bordet
Brussels, 1000
Universite Libre de Bruxelles - Hopital Erasme
Brussels, 1070
Ucl de Louvain St Luc
Brussels, 1200
Chu de Liege
Brussels, 4000
Grand Hopital de Charleroi
Charleroi, 6000
Universitair Ziekenhuis Gent
Ghent, 9000
Clinique Notre Dame de Grace
Gosselies, 6041
Hopital Jolimont
Haine-Saint-Paul, 7100
Ch Hutois
Huy, 4500
Az Groeninge - Campus Maria'S Voorzienigheid
Kortrijk, 8500
Chu Tivoli
La Louvière, 7100
Chr de La Citadelle
Liège, 4000
Clinique Saint Pierre
Ottignies, 1340
Universite Catholique de Louvain Mont Godinne
Yvoir, 5530
About this study
Official title: PHASE II STUDY OF MINI-CHOP PLUS OFATUMUMAB (O) IN NON PREVIOUSLY TREATED PATIENTS AGED OVER 80 YEARS WITH CD 20+ DIFFUSE LARGE B-CELL LYMPHOMA
This study is a multicentric, phase II, open-label, non-randomized trial evaluating the efficacy of O-miniCHOP in patients aged over 80 years with non previously treated CD20+ diffuse large B-cell lymphoma (age-adjusted IPI=0 to3), stage I, II, III or IV with a performance status ECOG from 0 to 4.
The anticipated study dates (start / end) are: 2010 - 2013. The study will evaluate a cohort of 120 patients (approximately 95 in France, 15 in Belgium, 5 in Switzerland and 5 in Portugal).
Patients will be recruited over 30 months and followed at least one year after the last patient has been included.
The duration of the treatment period is approximately 20 weeks.
- Being tested
- Ofatumumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OfatumumabDrug
solution for perfusion, 1000mg per cycle, 1 cycle every 3 weeks, total 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| Ofatumumab | Experimental | Not described Receives: Drug: Ofatumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2010 (estimated)
- Study startMay 2010
- Primary completionApr 2014
- Study completionApr 2014
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 Non Previously Treated CD20+ Diffuse Large B-cell LymphomaStudies 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Lymphoma Academic Research Organisation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peyrade Frederic, MD, Study chair, Lymphoma Study Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01195714
- Sponsor's protocol ID
- LNH09-7B
- Status last verified
- Mar 2018
- First submitted
- 3 Sep 2010
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Peyrade F, Bologna S, Delwail V, Emile JF, Pascal L, Ferme C, Schiano JM, Coiffier B, Corront B, Farhat H, Fruchart C, Ghesquieres H, Macro M, Tilly H, Choufi B, Delarue R, Fitoussi O, Gabarre J, Haioun C, Jardin F. Combination of ofatumumab and reduced-dose CHOP for diffuse large B-cell lymphomas in patients aged 80 years or older: an open-label, multicentre, single-arm, phase 2 trial from the LYSA group. Lancet Haematol. 2017 Jan;4(1):e46-e55. doi: 10.1016/S2352-3026(16)30171-5.
PubMed 28041583
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHASE II STUDY OF MINI-CHOP PLUS OFATUMUMAB (O) IN NON PREVIOUSLY TREATED PATIENTS AGED OVER 80 YEARS WITH CD 20+ DIFFUSE LARGE B-CELL LYMPHOMA
- ClinicalTrials.gov ID
- NCT01195714
- Acronym / sponsor ID
- LNH09-7B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- The Lymphoma Academic Research OrganisationUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 6 Sep 2010 (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.
This study is a multicentric, phase II, open-label, non-randomized trial evaluating the efficacy of O-miniCHOP in patients aged over 80 years with non previously treated CD20+ diffuse large B-cell lymphoma (age-adjusted IPI=0 to3), stage I, II, III or IV with a performance status ECOG from 0 to 4.
The anticipated study dates (start / end) are: 2010 - 2013. The study will evaluate a cohort of 120 patients (approximately 95 in France, 15 in Belgium, 5 in Switzerland and 5 in Portugal).
Patients will be recruited over 30 months and followed at least one year after the last patient has been included.
The duration of the treatment period is approximately 20 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ofatumumab | Experimental | Drug: Ofatumumab |
Who may qualify
- Ages
- 81 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Patient with histologically proven CD20+ diffuse large B-cell lymphoma (DLBCL) (WHO classification 2008) including clinical subtypes (primitive mediastinal, intravascular, etc.) May also be included : de Novo Transformed DLBCL from low grade lymphoma (Follicular, other...) and DLBCL associated with some small cell infiltration in bone marrow
- Or CD20+ B-cell lymphoma, with intermediate features between DLBCL and Burkitt or with intermediate features between DLBCL and classical Hodgkin lymphoma
- Or CD20+ Follicular lymphoma grade 3B
- Or CD20+ Aggressive B-cell lymphoma unclassifiable Aged over 80 years. Ann Arbor stage I, II, III or IV. All aaIPI Patient non previously treated. All ECOG performance status With a minimum life expectancy of 3 months. Negative HIV, HBV and HCV serologies test < 4 weeks (except after vaccination). Patient able to give his consent and having previously signed a written informed consent.
- Patient affiliated to social security system, if applicable
Key exclusion criteria (5 listed)
- Any other histological type of lymphoma, Burkitt included. Any history of treated or non-treated small-B cell lymphoma. Central nervous system or meningeal involvement by lymphoma. Contra-indication to any drug contained in the chemotherapy regimens. Any serious active disease (according to the investigator's decision). Poor renal function (creatinin level>150µmol/l), poor hepatic function (total bilirubin level>30mmol/l, transaminases>2.5 maximum normal level) unless these abnormalities are related to the lymphoma.
- Poor bone marrow reserve as defined by neutrophils <1.5 G/l or platelets <100 G/l, unless related to bone marrow infiltration.
- Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma. Patients previously diagnosed with prostate cancer are eligible if (1) their disease was T1-T2a, N0, M0, with a Gleason score <7, and a prostate specific antigen (PSA) <10 ng/mL prior to initial therapy, (2) they had definitive curative therapy (ie, prostatectomy or radiotherapy) >2 years before Day 1 of Cycle 1, and (3) at a minimum 2 years following therapy they had no clinical evidence of prostate cancer, and their PSA was undetectable if they underwent prostatectomy or <1 ng/mL if they did not undergo prostatectomy.
- Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
- Prior treatment with anti-CD20 monoclonal antibody or alemtuzumab within 3 months prior to start of therapy Adult patient under tutelage.
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 |
|---|---|---|
| Ofatumumabsolution for perfusion, 1000mg per cycle, 1 cycle every 3 weeks, total 6 cycles | Drug | Ofatumumab |
Primary outcome
Overall Survival
Time frame: 2 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 7 Mar 2018.
- Derived from this study: PubMed 28041583Peyrade F, Bologna S, Delwail V, Emile JF, Pascal L, Ferme C, Schiano JM, Coiffier B, Corront B, Farhat H, Fruchart C, Ghesquieres H, Macro M, Tilly H, Choufi B, Delarue R, Fitoussi O, Gabarre J, Haioun C, Jardin F. Combination of ofatumumab and reduced-dose CHOP for diffuse large B-cell lymphomas in patients aged 80 years or older: an open-label, multicentre, single-arm, phase 2 trial from the LYSA group. Lancet Haematol. 2017 Jan;4(1):e46-e55. doi: 10.1016/S2352-3026(16)30171-5.
Related trials for Non Previously Treated CD20+ Diffuse Large B-cell Lymphoma
Active, not recruitingPhase 2
A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Adult Patients With B-cell Non-Hodgkin Lymphoma Who Have Been Previously Treated With Other Cancer Therapies
B-cell Non-Hodgkin Lymphoma (B-NHL)
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.
Peyrade Frederic, MD study chair
Lymphoma Study Association
84 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 Ofatumumab in people with Non Previously Treated CD20+ Diffuse Large B-cell Lymphoma, run by The Lymphoma Academic Research Organisation at 84 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 5 inclusion and 5 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 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 84 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?
Overall Survival (time frame: 2 years). 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 NCT01195714, 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 7 Mar 2018.