DLBCL Clinical Trial
Official title:
Randomized Phase III Study Evaluating the Non-inferiority of a Treatment Adapted to the Early Response Evaluated With 18F-FDG PET Compared to a Standard Treatment, for Patients Aged From 18 to 80 Years With Low Risk (aa IPI = 0) Diffuse Large B-cells Non Hodgkin's Lymphoma CD 20+
Verified date | July 2020 |
Source | The Lymphoma Academic Research Organisation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this study, the investigators purpose is to evaluate the adaptation of treatment with
early response based on PET scan results after 2 cycles of chemotherapy, for patient aged
from 18 to 80 years, with low IPI DLBCL.
This is an open randomized study.
The primary endpoint is to evaluate the 3 years PFS with the aim to demonstrate the non
inferiority of the experimental arm in comparison to standard arm:
In standard arm, the patients will receive 6 cycles of R-CHOP 21 without taking into account
of PET scan results after 2 cycles.
In experimental arm, early good responder patients (defined as having a negative PET scan
after 2 cycles, confirmed after 4 cycles) will receive only 4 cycles of R-CHOP 21.
In both arms, if the PET scan remains positive after 4 cycles of chemotherapy, a biopsy exam
is needed to confirm the failure and an intensive chemotherapy is then recommended.
All of the patients, in both arms, will have an early evaluation with PET scan. All PET scan
will be reviewed by a group of expert according to Deauville criteria defined by Meignan et
al to adapt the decision after the 2nd cycle in experimental arm and after the 4th cycle for
all patients. The final evaluation of response will be made according to 2007 Cheson's
criteria.
Status | Completed |
Enrollment | 650 |
Est. completion date | May 23, 2020 |
Est. primary completion date | May 23, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Patient with histologically proven CD20+ diffuse large B-cell lymphoma (DLBCL) (WHO classification 2008) including clinical subtypes (primitive mediastinal, intravascular, etc.). Patients with De Novo Transformed DLBCL from low grade lymphoma (Follicular, other...) may also be included; 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. - Age from18 to 80 years. - Patient not previously treated. - Ann Arbor Stage : I or II. - Normal level of LDH. - ECOG performance status (PS) < 2. - Age-adjusted international prognostic index (aaIPI) = 0. - Baseline PET (PET0) performed before any treatment, even in absence of known lesion (for stage I for which the lesion has been removed for diagnostic reason). - Having previously signed a written informed consent. - The subject must be covered by a social security system (in France). 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. - Poor renal function (creatinin level >150 mmol/L), poor hepatic function (total bilirubin level >30 mmol/L, transaminases >2.5 ULN) unless these abnormalities are related to the lymphoma. - Poor bone marrow reserve as defined by Absolute Neutrophils Count (ANC) <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. - Any serious active disease (according to the investigator's decision). - Positive HIV, HBV and HCV serologies before inclusion (except after hepatitis B vaccination or for patients who are HBs Ag negative, anti-HBs positive and/or anti-HBc positive but viral DNA negative). - Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy. - Pregnant or lactating women or women of childbearing potential not currently practicing an adequate method of contraception. - Adult patient under tutelage. - Impossibility to perform a baseline PET scan (PET0) before randomization and treatment start. |
Country | Name | City | State |
---|---|---|---|
Belgium | ZNA Stuivenberg | Antwerpen | |
Belgium | A. Z. Sint-Jan | Bruges | |
Belgium | Institut Jules Bordet | Bruxelles | |
Belgium | Université Catholique de Louvain Saint Luc | Bruxelles | |
Belgium | Université Libre de Bruxelles - Hôpital Erasme | Bruxelles | |
Belgium | Grand Hôpital de Charleroi | Charleroi | |
Belgium | UZ Gent | Gent | |
Belgium | Hôpital Jolimont | Haine Saint Paul | |
Belgium | CHU de Liège | Liege | |
Belgium | Clinique Saint Joseph | Mons | |
Belgium | Clinique Saint Pierre | Ottignies | |
Belgium | Centre Hospitalier de Wallonie Picarde - CHwapi | Tournai | |
Belgium | CH de la Tourelle-Peltzer | Verviers | |
Belgium | UCL Mont Godinne | Yvoir | |
France | CHU Angers | Angers | |
France | Centre Hospitalier Victor Dupouy | Argenteuil | |
France | CH d'ARRAS | Arras | |
France | CH d'Avignon | Avignon | |
France | CH de la Côte Basque | Bayonne | |
France | CHU de Besançon - Hôpital Jean Minjoz | Besançon | |
France | Institut Bergonié - Bordeaux | Bordeaux | |
France | Polyclinique Bordeaux Nord Aquitaine | Bordeaux | |
France | CH du Dr Duchenne | Boulogne-sur-Mer | |
France | CH de Bourg-en-Bresse | Bourg-en-Bresse | |
France | IHBN - CHU Côte de Nacre | Caen | |
France | CH de Cannes | Cannes | |
France | Médipôle de Savoie | Challes-les-Eaux | |
France | Hôpital de Chalon | Chalon-sur-Saône | |
France | CH de Chambéry | Chambéry | |
France | Hôpital d'Instruction des Armées Percy | Clamart | |
France | CHU Estaing - Clermont Ferrand | Clermont Ferrand | |
France | Hôpital Pasteur | Colmar | |
France | CH de Compiègne | Compiègne | |
France | Centre Hospitalier Alpes Léman | Contamine-sur-Arve | |
France | CH Sud Francilien | Corbeil Essonnes | |
France | Hôpital Henri MONDOR | Créteil | |
France | Chu Dijon | Dijon | |
France | CH de Dunkerque | Dunkerque | |
France | CHU de Grenoble - Hôpital Albert Michallon | Grenoble | |
France | CH Départemental Vendée | La Roche-sur-Yon | |
France | CH de Versailles | Le Chesnay | |
France | CHU Bicetre | Le Kremlin Bicêtre | |
France | CH de Lens | Lens | |
France | CHRU de Lille | Lille | |
France | Hôpital Saint Vincent | Lille | |
France | CHU de Limoges | Limoges | |
France | Centre Léon Bérard | Lyon | |
France | Clinique de la Sauvegarde | Lyon | |
France | Clinique Mutualiste Eugène André | Lyon | |
France | Hôpital des Chanaux | Macon | |
France | Institut Paoli Calmettes | Marseille | |
France | CH de Meaux | Meaux | |
France | CH Marc Jacquet | Melun | |
France | Hôpital Notre Dame du Bon Secours | Metz | |
France | CH de Mulhouse | Mulhouse | |
France | Centre d'Oncologie de Gentilly | Nancy | |
France | Centre Antoine Lacassagne | Nice | |
France | CHU de Nice | Nice | |
France | Hôpital de la Pitié Salpétrière | Paris | |
France | Hôpital Necker | Paris | |
France | Hôpital Saint Antoine | Paris | |
France | Hôpital Saint Antoine, Service d'hématologie du Pr Marie | Paris | |
France | Hôpital Saint Louis | Paris | |
France | Institut Curie | Paris | |
France | Hôpital LYON SUD | Pierre Bénite | |
France | CHU de Poitiers | Poitiers | |
France | CH Rene Dubos | Pontoise | |
France | CH de la Région d'Annecy | Pringy | |
France | CHU de Reims | Reims | |
France | CHU de Rennes - Hôpital Pontchaillou | Rennes | |
France | Centre Hospitalier de Roubaix | Roubaix | |
France | Centre Henri Becquerel | Rouen | |
France | Hôpital René Huguenin | Saint Cloud | |
France | Institut de cancérologie de la Loire | Saint Priest en Jarez | |
France | CH de Saint-Brieuc - Hôpital Yves Le Foll | Saint-Brieuc | |
France | CHU de Strasbourg | Strasbourg | |
France | Hôpitaux du Leman | Thonon-les-Bains | |
France | Hôpital Sainte Musse | Toulon | |
France | CHU de Tours - Hôpital Bretonneau | Tours | |
France | CH de Troyes | Troyes | |
France | CH de Valence | Valence | |
France | CHU Brabois | Vandoeuvre les Nancy | |
France | Institut Gustave Roussy | Villejuif |
Lead Sponsor | Collaborator |
---|---|
The Lymphoma Academic Research Organisation | CHU de Nancy |
Belgium, France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression Free Survival | Evaluate by PFS at 3 years the non-inferiority of a chemotherapy treatment with 4 or 6 cycles of R-CHOP 21, determined according to early response assessed by PET at the end of 2 cycles versus standard chemotherapy of 6 cycles of R-CHOP 21 in patients with DLBCL lymphoma CD20+ with no factors of the IPI age adjusted. | 3 years | |
Secondary | DELTA SUV | Determine the decrease of SUV max between PET at baseline, PET after cycle 2 and PET after cycle 4 and evaluate the changes predictive interest. | 3 weeks post C4 last patient | |
Secondary | Overall Survival, EFS, response duration, DFS | Assess the overall survival, the EFS (Event Free Survival - events defined as death from any cause, relapse for complete responders and undocumented complete responders, progression during or after treatment, initiation of a new anti-lymphoma therapy), the response duration, and the DFS for complete responders (disease free survival). | 3 years | |
Secondary | prognostic impact of the existence of a high tumor burden at diagnosis (> 10 cm) on PFS | Evaluate the prognostic impact of the existence of a high tumor burden at diagnosis (> 10 cm). | 3 years | |
Secondary | biological factors | Identify the biological factors on blood samples and on tumor biopsy influencing the patient treatment response and prognosis. | 3 weeks post last cycle and 3years survival | |
Secondary | Overall Response Rate | Evaluate the overall response rate according to IWC (International Harmonization Project - Cheson 2007) (CR, PR) after 4 or 6 cycles of R-CHOP21 according to the treatment arm. | 3 weeks post last cycle last patient | |
Secondary | Rate of good responders according to results at PET after C2 | Evaluate the rate of negative PET2 | 3 weeks post C2 last patient |
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