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CompletedNCT01195714Updated Mar 7, 2018

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

A Phase 2 interventional study of Ofatumumab in Non Previously Treated CD20+ Diffuse Large B-cell Lymphoma, sponsored by The Lymphoma Academic Research Organisation. Completed at 84 sites in 2 countries. Open to participants aged 81 Years and older. Per ClinicalTrials.gov, last updated 2018-03-07.

Sponsored by The Lymphoma Academic Research Organisation · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
120
Allocation
Not applicable
Ages
81 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Non Previously Treated CD20+ Diffuse Large B-cell Lymphoma
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In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 120 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

The Lymphoma Academic Research Organisation is the lead sponsor of 60 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
81 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    Ofatumumab

    Drug: Ofatumumab

Interventions

  • DrugOfatumumab

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

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What researchers measure

Primary outcomes

  1. Overall Survival

    Time frame: 2 years

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Study locations

84 sites
  • Zna Stuivenberg
    Antwerpen, 2060, Belgium
  • RHMS
    Baudour, Belgium
  • Az Sint Jan Av
    Bruges, 8000, Belgium
  • Institut Jules Bordet
    Bruxelles, 1000, Belgium
  • Universite Libre de Bruxelles - Hopital Erasme
    Bruxelles, 1070, Belgium
  • Ucl de Louvain St Luc
    Bruxelles, 1200, Belgium
  • Chu de Liege
    Bruxelles, 4000, Belgium
  • Grand Hopital de Charleroi
    Charleroi, 6000, Belgium
  • Universitair Ziekenhuis Gent
    Gent, 9000, Belgium
  • Clinique Notre Dame de Grace
    Gosselies, 6041, Belgium
  • Hopital Jolimont
    Haine Saint Paul, 7100, Belgium
  • Ch Hutois
    Huy, 4500, Belgium
  • Az Groeninge - Campus Maria'S Voorzienigheid
    Kortrijk, 8500, Belgium
  • Chu Tivoli
    La Louvière, 7100, Belgium
  • Chr de La Citadelle
    Liège, 4000, Belgium
  • Clinique Saint Pierre
    Ottignies, 1340, Belgium
  • Universite Catholique de Louvain Mont Godinne
    Yvoir, 5530, Belgium
  • Ch Du Pays D'Aix
    Aix En Provence, 13616, France
  • Ch Antibes
    Antibes, 06606, France
  • Ch Henri Duffaut
    Avignon, 84902, France
  • Hopital de Bayonne
    Bayonne, 64100, France
  • Hopital Avicenne
    Bobigny, 93009, France
  • Polyclinique Bordeaux Nord Aquitaine
    Bordeaux, 33300, France
  • Ch Du Dr Duchenne
    Boulogne sur Mer, 62321, France
  • Ch de Bour En Bresse
    Bourg en Bresse, 01000, France
  • Chu de Brive
    Brive la Gaillarde, 19190, France
  • Chu Cote de Nacre
    Caen, 14033, France
  • Centre Henri Baclesse
    Caen, 14076, France
  • Ch de Cannes
    Cannes, 06401, France
  • Hopital de Chalon
    Chalon sur Saone, 71100, France
  • Ch Chambery
    Chambery, 73011, France
  • Ch de Chartres - Hopital Louis Pasteur
    Chartres, 28018, France
  • Hopital Antoine Beclere
    Clamart, 92140, France
  • Hopital D'Instruction Des Armees Percy
    Clamart, 92141, France
  • Hopital Pasteur
    Colmar, 68024, France
  • Ch Compiege
    Compiegne, 60321, France
  • Ch Sud Francilien
    Corbeil-Essonnes, 91106, France
  • Hopital Henri Mondor
    Creteil, 94010, France
  • Chu Le Bocage
    Dijon, 21034, France
  • Ch de Dunkerque
    Dunkerque, 59385, France
  • Ch Dunkerque
    Dunkerque, 59385, France
  • Ch Frejus St Raphael
    Frejus, 83608, France
  • CH GERET
    Gueret, 23000, France
  • Hopital Saint Louis
    La Rochelle, 17019, France
  • Hopital Andre Mignot
    Le Chesnay, 78157, France
  • Hopital Bicetre
    Le Kremlin-Bicêtre, 94275, France
  • Ch de Meulan
    Les Mureaux, 78250, France
  • Hopital St Vincent de Paul
    Lille, 59020, France
  • Chu Claude Hurriez
    Lille, 59037, France
  • Chu Dupuytren
    Limoges, 87042, France
  • Centre Leon Berard
    Lyon, 69373, France
  • Hopital Des Chanaux
    Macon, 71018, France
  • Chu Hopital Nord
    Marseille, 13015, France
  • Institut Paoli Calmette
    Marseille, 13723, France
  • Chu de Meaux
    Meaux, 77104, France
  • Chu Marc Jacquet
    Melun, 77011, France
  • Hopital Bon Secours
    Metz, 57019, France
  • Crlc Val D'Aurelle - Paul Lamarque
    Montpellier, 34298, France
  • Centre Azureen de Cancerologie
    Mougins, 06250, France
  • Hopital Americain de Paris
    Neuilly sur Seine, 92200, France
  • Centre Antoine Lacassagne
    Nice, 06003, France
  • Hopital St Antoine
    Paris, 75012, France
  • Hotel Dieu
    Paris, 75181, France
  • Hopital St Louis
    Paris, 75475, France
  • Hopital de La Pitie Salpetriere
    Paris, 75651, France
  • Institut Curie
    Paris, 75674, France
  • Hopital Necker
    Paris, 75743, France
  • Ch Marechal Joffre
    Perpignan, 66046, France
  • Chu Lyon Sud
    Pierre Bénite, 69495, France
  • Chu de Poitiers - Hopital de Miletrie
    Poitiers, 86021, France
  • Ch Rene Dubos
    Pontoise, 95301, France
  • Ch Annecy
    Pringy, 74370, France
  • Chu Robert Debre
    Reims, 51092, France
  • Ch de Roubaix - Hopital Victor Provo
    Roubaix, 59100, France
  • Clinique Mathilde
    Rouen, 76000, France
  • Centre Henri Becquerel
    Rouen, 76038, France
  • Centre Rene Hugenin
    Saint Cloud, 92210, France
  • Ch de Saint Germain
    Saint Germain en Laye, 78105, France
  • Hopital Font Pre
    Toulon, 83056, France
  • Chu de Toulouse
    Toulouse, 31059, France
  • Ch de Troyes
    Troyes, 10003, France
  • Hopital de Valence
    Valence, 26953, France
  • Chu Brabois
    Vandoeuvre Les Nancy, 54511, France
  • Institut Gustave Roussy
    Villejuif, 94805, France
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References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01195714
Lead sponsor
The Lymphoma Academic Research Organisation
Responsible party
Sponsor
First posted
Sep 6, 2010
Start date
May 2010
Primary completion
Apr 2014
Completion
Apr 2014
Last update
Mar 7, 2018

Study contacts

Peyrade Frederic, MD
study chair · Lymphoma Study Association

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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