Clinical trial NCT01195714: Study of Mini-Chop Plus Ofatumumab To Treat Cd 20+ Diffuse Large B-Cell Lymphoma In Patients Aged Over 80 Years
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Previously Treated CD20+ Diffuse Large B-cell Lymphoma
Lead sponsor: The Lymphoma Academic Research Organisation
Sponsor class: OTHER
First posted: 2010-09-06
Enrollment: 120
Sex: ALL
Minimum age (years): 81
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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.

Primary outcomes:
measure: Overall Survival
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Zna Stuivenberg
city: Baudour
country: Belgium
facility: RHMS
city: Bruges
country: Belgium
facility: Az Sint Jan Av
city: Bruxelles
country: Belgium
facility: Institut Jules Bordet
city: Bruxelles
country: Belgium
facility: Universite Libre de Bruxelles - Hopital Erasme
city: Bruxelles
country: Belgium
facility: Ucl de Louvain St Luc
city: Bruxelles
country: Belgium
facility: Chu de Liege
city: Charleroi
country: Belgium
facility: Grand Hopital de Charleroi
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Gosselies
country: Belgium
facility: Clinique Notre Dame de Grace
city: Haine Saint Paul
country: Belgium
facility: Hopital Jolimont
city: Huy
country: Belgium
facility: Ch Hutois
city: Kortrijk
country: Belgium
facility: Az Groeninge - Campus Maria'S Voorzienigheid
city: La Louvière
country: Belgium
facility: Chu Tivoli
city: Liège
country: Belgium
facility: Chr de La Citadelle
city: Ottignies
country: Belgium
facility: Clinique Saint Pierre
city: Yvoir
country: Belgium
facility: Universite Catholique de Louvain Mont Godinne
city: Aix En Provence
country: France
facility: Ch Du Pays D'Aix
city: Antibes
country: France
facility: Ch Antibes
city: Avignon
country: France
facility: Ch Henri Duffaut
city: Bayonne
country: France
facility: Hopital de Bayonne
city: Bobigny
country: France
facility: Hopital Avicenne
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine
city: Boulogne sur Mer
country: France
facility: Ch Du Dr Duchenne
city: Bourg en Bresse
country: France
facility: Ch de Bour En Bresse
city: Brive la Gaillarde
country: France
facility: Chu de Brive
city: Caen
country: France
facility: Chu Cote de Nacre
city: Caen
country: France
facility: Centre Henri Baclesse
city: Cannes
country: France
facility: Ch de Cannes
city: Chalon sur Saone
country: France
facility: Hopital de Chalon
city: Chambery
country: France
facility: Ch Chambery
city: Chartres
country: France
facility: Ch de Chartres - Hopital Louis Pasteur
city: Clamart
country: France
facility: Hopital Antoine Beclere
city: Clamart
country: France
facility: Hopital D'Instruction Des Armees Percy
city: Colmar
country: France
facility: Hopital Pasteur
city: Compiegne
country: France
facility: Ch Compiege
city: Corbeil-Essonnes
country: France
facility: Ch Sud Francilien
city: Creteil
country: France
facility: Hopital Henri Mondor
city: Dijon
country: France
facility: Chu Le Bocage
city: Dunkerque
country: France
facility: Ch de Dunkerque
city: Dunkerque
country: France
facility: Ch Dunkerque
city: Frejus
country: France
facility: Ch Frejus St Raphael
city: Gueret
country: France
facility: CH GERET
city: La Rochelle
country: France
facility: Hopital Saint Louis
city: Le Chesnay
country: France
facility: Hopital Andre Mignot
city: Le Kremlin-Bicêtre
country: France
facility: Hopital Bicetre
city: Les Mureaux
country: France
facility: Ch de Meulan
city: Lille
country: France
facility: Hopital St Vincent de Paul
city: Lille
country: France
facility: Chu Claude Hurriez
city: Limoges
country: France
facility: Chu Dupuytren
city: Lyon
country: France
facility: Centre Leon Berard
city: Macon
country: France
facility: Hopital Des Chanaux
city: Marseille
country: France
facility: Chu Hopital Nord
city: Marseille
country: France
facility: Institut Paoli Calmette
city: Meaux
country: France
facility: Chu de Meaux
city: Melun
country: France
facility: Chu Marc Jacquet
city: Metz
country: France
facility: Hopital Bon Secours
city: Montpellier
country: France
facility: Crlc Val D'Aurelle - Paul Lamarque
city: Mougins
country: France
facility: Centre Azureen de Cancerologie
city: Neuilly sur Seine
country: France
facility: Hopital Americain de Paris
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Hopital St Antoine
city: Paris
country: France
facility: Hotel Dieu
city: Paris
country: France
facility: Hopital St Louis
city: Paris
country: France
facility: Hopital de La Pitie Salpetriere
city: Paris
country: France
facility: Institut Curie
city: Paris
country: France
facility: Hopital Necker
city: Perpignan
country: France
facility: Ch Marechal Joffre
city: Pierre Bénite
country: France
facility: Chu Lyon Sud
city: Poitiers
country: France
facility: Chu de Poitiers - Hopital de Miletrie
city: Pontoise
country: France
facility: Ch Rene Dubos
city: Pringy
country: France
facility: Ch Annecy
city: Reims
country: France
facility: Chu Robert Debre
city: Roubaix
country: France
facility: Ch de Roubaix - Hopital Victor Provo
city: Rouen
country: France
facility: Clinique Mathilde
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Saint Cloud
country: France
facility: Centre Rene Hugenin
city: Saint Germain en Laye
country: France
facility: Ch de Saint Germain
city: Toulon
country: France
facility: Hopital Font Pre
city: Toulouse
country: France
facility: Chu de Toulouse
city: Troyes
country: France
facility: Ch de Troyes
city: Valence
country: France
facility: Hopital de Valence
city: Vandoeuvre Les Nancy
country: France
facility: Chu Brabois
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Lymphoma Study Association
name: Peyrade Frederic, MD
role: STUDY_CHAIR
References:
citation: 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.