Study of Mini-Chop Plus Ofatumumab To Treat Cd 20+ Diffuse Large B-Cell Lymphoma In Patients Aged Over 80 Years
NCT ID: NCT01195714
Last Updated: 2018-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
120 participants
INTERVENTIONAL
2010-05-31
2014-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ofatumumab
Ofatumumab
solution for perfusion, 1000mg per cycle, 1 cycle every 3 weeks, total 6 cycles
Interventions
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Ofatumumab
solution for perfusion, 1000mg per cycle, 1 cycle every 3 weeks, total 6 cycles
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
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.
81 Years
ALL
No
Sponsors
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The Lymphoma Academic Research Organisation
OTHER
Responsible Party
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Principal Investigators
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Peyrade Frederic, MD
Role: STUDY_CHAIR
Lymphoma Study Association
Locations
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Zna Stuivenberg
Antwerp, , Belgium
RHMS
Baudour, , Belgium
Az Sint Jan Av
Bruges, , Belgium
Institut Jules Bordet
Brussels, , Belgium
Universite Libre de Bruxelles - Hopital Erasme
Brussels, , Belgium
Ucl de Louvain St Luc
Brussels, , Belgium
Chu de Liege
Brussels, , Belgium
Grand Hopital de Charleroi
Charleroi, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Clinique Notre Dame de Grace
Gosselies, , Belgium
Hopital Jolimont
Haine-Saint-Paul, , Belgium
Ch Hutois
Huy, , Belgium
Az Groeninge - Campus Maria'S Voorzienigheid
Kortrijk, , Belgium
Chu Tivoli
La Louvière, , Belgium
Chr de La Citadelle
Liège, , Belgium
Clinique Saint Pierre
Ottignies, , Belgium
Universite Catholique de Louvain Mont Godinne
Yvoir, , Belgium
Ch Du Pays D'Aix
Aix-en-Provence, , France
Ch Antibes
Antibes, , France
Ch Henri Duffaut
Avignon, , France
Hopital de Bayonne
Bayonne, , France
Hopital Avicenne
Bobigny, , France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, , France
Ch Du Dr Duchenne
Boulogne-sur-Mer, , France
Ch de Bour En Bresse
Bourg-en-Bresse, , France
Chu de Brive
Brive-la-Gaillarde, , France
Chu Cote de Nacre
Caen, , France
Centre Henri Baclesse
Caen, , France
Ch de Cannes
Cannes, , France
Hopital de Chalon
Chalon-sur-Saône, , France
Ch Chambery
Chambéry, , France
Ch de Chartres - Hopital Louis Pasteur
Chartres, , France
Hopital Antoine Beclere
Clamart, , France
Hopital D'Instruction Des Armees Percy
Clamart, , France
Hopital Pasteur
Colmar, , France
Ch Compiege
Compiègne, , France
Ch Sud Francilien
Corbeil-Essonnes, , France
Hopital Henri Mondor
Créteil, , France
Chu Le Bocage
Dijon, , France
Ch de Dunkerque
Dunkirk, , France
Ch Dunkerque
Dunkirk, , France
Ch Frejus St Raphael
Fréjus, , France
CH GERET
Guéret, , France
Hopital Saint Louis
La Rochelle, , France
Hopital Andre Mignot
Le Chesnay, , France
Hopital Bicetre
Le Kremlin-Bicêtre, , France
Ch de Meulan
Les Mureaux, , France
Hopital St Vincent de Paul
Lille, , France
Chu Claude Hurriez
Lille, , France
Chu Dupuytren
Limoges, , France
Centre Leon Berard
Lyon, , France
Chu Hopital Nord
Marseille, , France
Institut Paoli Calmette
Marseille, , France
Hopital Des Chanaux
Mâcon, , France
Chu de Meaux
Meaux, , France
Chu Marc Jacquet
Melun, , France
Hopital Bon Secours
Metz, , France
Crlc Val D'Aurelle - Paul Lamarque
Montpellier, , France
Centre Azureen de Cancerologie
Mougins, , France
Hopital Americain de Paris
Neuilly-sur-Seine, , France
Centre Antoine Lacassagne
Nice, , France
Hopital St Antoine
Paris, , France
Hotel Dieu
Paris, , France
Hopital St Louis
Paris, , France
Hopital de La Pitie Salpetriere
Paris, , France
Institut Curie
Paris, , France
Hopital Necker
Paris, , France
Ch Marechal Joffre
Perpignan, , France
Chu Lyon Sud
Pierre-Bénite, , France
Chu de Poitiers - Hopital de Miletrie
Poitiers, , France
Ch Rene Dubos
Pontoise, , France
Ch Annecy
Pringy, , France
Chu Robert Debre
Reims, , France
Ch de Roubaix - Hopital Victor Provo
Roubaix, , France
Clinique Mathilde
Rouen, , France
Centre Henri Becquerel
Rouen, , France
Centre Rene Hugenin
Saint-Cloud, , France
Ch de Saint Germain
Saint-Germain-en-Laye, , France
Hopital Font Pre
Toulon, , France
Chu de Toulouse
Toulouse, , France
Ch de Troyes
Troyes, , France
Hopital de Valence
Valence, , France
Chu Brabois
Vandœuvre-lès-Nancy, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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References
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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.
Other Identifiers
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LNH09-7B
Identifier Type: -
Identifier Source: org_study_id
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