Study of Mini-Chop Plus Ofatumumab To Treat Cd 20+ Diffuse Large B-Cell Lymphoma In Patients Aged Over 80 Years

NCT01195714 | Completed Phase 2

• 1 other identifier: LNH09-7B
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 84

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.

Conditions

Non Previously Treated CD20+ Diffuse Large B-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  2 years

Study Arms (1)

Ofatumumab

EXPERIMENTAL

Drug: Ofatumumab

Interventions

Ofatumumab DRUG

solution for perfusion, 1000mg per cycle, 1 cycle every 3 weeks, total 6 cycles

Ofatumumab

Eligibility Criteria

• Age: 81 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Lymphoma Academic Research Organisation: lead

Study Sites (84)

Zna Stuivenberg

Antwerp, 2060, Belgium

Location

RHMS

Baudour, Belgium

Location

Az Sint Jan Av

Bruges, 8000, Belgium

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Universite Libre de Bruxelles - Hopital Erasme

Brussels, 1070, Belgium

Location

Ucl de Louvain St Luc

Brussels, 1200, Belgium

Location

Chu de Liege

Brussels, 4000, Belgium

Location

Grand Hopital de Charleroi

Charleroi, 6000, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Clinique Notre Dame de Grace

Gosselies, 6041, Belgium

Location

Hopital Jolimont

Haine-Saint-Paul, 7100, Belgium

Location

Ch Hutois

Huy, 4500, Belgium

Location

Az Groeninge - Campus Maria'S Voorzienigheid

Kortrijk, 8500, Belgium

Location

Chu Tivoli

La Louvière, 7100, Belgium

Location

Chr de La Citadelle

Liège, 4000, Belgium

Location

Clinique Saint Pierre

Ottignies, 1340, Belgium

Location

Universite Catholique de Louvain Mont Godinne

Yvoir, 5530, Belgium

Location

Ch Du Pays D'Aix

Aix-en-Provence, 13616, France

Location

Ch Antibes

Antibes, 06606, France

Location

Ch Henri Duffaut

Avignon, 84902, France

Location

Hopital de Bayonne

Bayonne, 64100, France

Location

Hopital Avicenne

Bobigny, 93009, France

Location

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, 33300, France

Location

Ch Du Dr Duchenne

Boulogne-sur-Mer, 62321, France

Location

Ch de Bour En Bresse

Bourg-en-Bresse, 01000, France

Location

Chu de Brive

Brive-la-Gaillarde, 19190, France

Location

Chu Cote de Nacre

Caen, 14033, France

Location

Centre Henri Baclesse

Caen, 14076, France

Location

Ch de Cannes

Cannes, 06401, France

Location

Hopital de Chalon

Chalon-sur-Saône, 71100, France

Location

Ch Chambery

Chambéry, 73011, France

Location

Ch de Chartres - Hopital Louis Pasteur

Chartres, 28018, France

Location

Hopital Antoine Beclere

Clamart, 92140, France

Location

Hopital D'Instruction Des Armees Percy

Clamart, 92141, France

Location

Hopital Pasteur

Colmar, 68024, France

Location

Ch Compiege

Compiègne, 60321, France

Location

Ch Sud Francilien

Corbeil-Essonnes, 91106, France

Location

Hopital Henri Mondor

Créteil, 94010, France

Location

Chu Le Bocage

Dijon, 21034, France

Location

Ch de Dunkerque

Dunkirk, 59385, France

Location

Ch Dunkerque

Dunkirk, 59385, France

Location

Ch Frejus St Raphael

Fréjus, 83608, France

Location

CH GERET

Guéret, 23000, France

Location

Hopital Saint Louis

La Rochelle, 17019, France

Location

Hopital Andre Mignot

Le Chesnay, 78157, France

Location

Hopital Bicetre

Le Kremlin-Bicêtre, 94275, France

Location

Ch de Meulan

Les Mureaux, 78250, France

Location

Hopital St Vincent de Paul

Lille, 59020, France

Location

Chu Claude Hurriez

Lille, 59037, France

Location

Chu Dupuytren

Limoges, 87042, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Chu Hopital Nord

Marseille, 13015, France

Location

Institut Paoli Calmette

Marseille, 13723, France

Location

Hopital Des Chanaux

Mâcon, 71018, France

Location

Chu de Meaux

Meaux, 77104, France

Location

Chu Marc Jacquet

Melun, 77011, France

Location

Hopital Bon Secours

Metz, 57019, France

Location

Crlc Val D'Aurelle - Paul Lamarque

Montpellier, 34298, France

Location

Centre Azureen de Cancerologie

Mougins, 06250, France

Location

Hopital Americain de Paris

Neuilly-sur-Seine, 92200, France

Location

Centre Antoine Lacassagne

Nice, 06003, France

Location

Hopital St Antoine

Paris, 75012, France

Location

Hotel Dieu

Paris, 75181, France

Location

Hopital St Louis

Paris, 75475, France

Location

Hopital de La Pitie Salpetriere

Paris, 75651, France

Location

Institut Curie

Paris, 75674, France

Location

Hopital Necker

Paris, 75743, France

Location

Ch Marechal Joffre

Perpignan, 66046, France

Location

Chu Lyon Sud

Pierre-Bénite, 69495, France

Location

Chu de Poitiers - Hopital de Miletrie

Poitiers, 86021, France

Location

Ch Rene Dubos

Pontoise, 95301, France

Location

Ch Annecy

Pringy, 74370, France

Location

Chu Robert Debre

Reims, 51092, France

Location

Ch de Roubaix - Hopital Victor Provo

Roubaix, 59100, France

Location

Clinique Mathilde

Rouen, 76000, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Centre Rene Hugenin

Saint-Cloud, 92210, France

Location

Ch de Saint Germain

Saint-Germain-en-Laye, 78105, France

Location

Hopital Font Pre

Toulon, 83056, France

Location

Chu de Toulouse

Toulouse, 31059, France

Location

Ch de Troyes

Troyes, 10003, France

Location

Hopital de Valence

Valence, 26953, France

Location

Chu Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Related Publications (1)

• 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.

  PMID: 28041583 DERIVED

MeSH Terms

Interventions

ofatumumab

Study Officials

• Peyrade Frederic, MD

  Lymphoma Study Association

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2010
• First Posted: September 6, 2010
• Study Start: May 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: March 7, 2018

Record last verified: 2018-03

Locations

BE (17); FR (67)