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

March 6, 2018 updated by: The Lymphoma Academic Research Organisation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

81 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ofatumumab
Drug: Ofatumumab
solution for perfusion, 1000mg per cycle, 1 cycle every 3 weeks, total 6 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Lymphoma Academic Research Organisation

Investigators

  • Study Chair: Peyrade Frederic, MD, Lymphoma Study Association

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

September 3, 2010

First Submitted That Met QC Criteria

September 3, 2010

First Posted (Estimate)

September 6, 2010

Study Record Updates

Last Update Posted (Actual)

March 7, 2018

Last Update Submitted That Met QC Criteria

March 6, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LNH09-7B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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