Non Previously Treated CD20+ Diffuse Large B-cell Lymphoma Clinical Trial
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
| Verified date | March 2018 |
| Source | The Lymphoma Academic Research Organisation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 120 |
| Est. completion date | April 2014 |
| Est. primary completion date | April 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 81 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Zna Stuivenberg | Antwerpen | |
| Belgium | RHMS | Baudour | |
| Belgium | Az Sint Jan Av | Bruges | |
| Belgium | Chu de Liege | Bruxelles | |
| Belgium | Institut Jules Bordet | Bruxelles | |
| Belgium | Ucl de Louvain St Luc | Bruxelles | |
| Belgium | Universite Libre de Bruxelles - Hopital Erasme | Bruxelles | |
| Belgium | Grand Hopital de Charleroi | Charleroi | |
| Belgium | Universitair Ziekenhuis Gent | Gent | |
| 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 | |
| France | 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 | Centre Henri Baclesse | Caen | |
| France | Chu Cote de Nacre | Caen | |
| France | Ch de Cannes | Cannes | |
| France | Hopital de Chalon | Chalon sur Saone | |
| France | Ch Chambery | Chambery | |
| 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 | Compiegne | |
| France | Ch Sud Francilien | Corbeil-Essonnes | |
| France | Hopital Henri Mondor | Creteil | |
| France | Chu Le Bocage | Dijon | |
| France | Ch de Dunkerque | Dunkerque | |
| France | Ch Dunkerque | Dunkerque | |
| France | Ch Frejus St Raphael | Frejus | |
| France | CH GERET | Gueret | |
| 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 | Chu Claude Hurriez | Lille | |
| France | Hopital St Vincent de Paul | Lille | |
| France | Chu Dupuytren | Limoges | |
| France | Centre Leon Berard | Lyon | |
| France | Hopital Des Chanaux | Macon | |
| France | Chu Hopital Nord | Marseille | |
| France | Institut Paoli Calmette | Marseille | |
| 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 de La Pitie Salpetriere | Paris | |
| France | Hopital Necker | Paris | |
| France | Hopital St Antoine | Paris | |
| France | Hopital St Louis | Paris | |
| France | Hotel Dieu | Paris | |
| France | Institut Curie | 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 | Centre Henri Becquerel | Rouen | |
| France | Clinique Mathilde | 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 | Vandoeuvre Les Nancy | |
| France | Institut Gustave Roussy | Villejuif |
| Lead Sponsor | Collaborator |
|---|---|
| The Lymphoma Academic Research Organisation |
Belgium, France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall Survival | 2 years |