Study of a Treatment Driven by Early PET Response to a Treatment Not Monitored by Early PET in Patients With AA Stage 3-4 or 2B HL
- Conditions
- Hodgkin's Lymphoma
- Interventions
- Drug: BEACOPPescDrug: BEACOPPesc - ABVD - PET2
- Registration Number
- NCT01358747
- Lead Sponsor
- Centre Hospitalier Universitaire Dijon
- Brief Summary
All study treatments have proven efficacy in the treatment in Hodgkin lymphoma (HL). It is hoped that patients will achieve a good response to both induction therapies consisting either of 4 cycles of BEACOPPesc (Bleomycin, Etoposide, Doxorubicin, Cyclophosphamide, Vincristine, Procarbazine, and Prednisone) or 2 cycles of BEACOPPesc plus 2 cycles of ABVD (Adriamycine, Bléomycine, Vinblastine, Décarbazine).
The use of F-FDG Position Emission Tomography performed after 2 cycles of chemotherapy (PET2) in the experimental arm will help to stratify patients in order to restrict the BEACOPPesc therapy continuation to those patients who achieved only a partial response after 2 BEACOPPesc regimen and to allow a conventional dose ABVD chemotherapy strategy for PET2 negative patients. For all patients included in the trial the achievement of a good response to induction treatment will be checked after four cycles of induction treatment including a centrally reviewed PET assessment
Patients will be randomized after verification of eligibility and before the start of the protocol treatment.Patients will be randomly assigned to the standard treatment arm not monitored by early PET, or the experimental treatment arm driven by the PET2 result.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
- Patient with a first diagnosis of classical Hodgkin lymphoma according to world health organization (WHO) criteria excluding nodular lymphocyte predominant subtype
- Age of 16 to 60 years
- No previous treatment for Hodgkin lymphoma
- Ann Arbor stages:
IIB with mediastinum/thorax ≥0.33 or extra nodal localization III IV
- Baseline 18-FDG PET scan (PET0)(F-FDG Positon Emission Tomography) performed before any treatment with at least one hypermetabolic lesion
- Eastern Cooperative Oncology Group (ECOG) performance status < 3
- With a minimum life expectancy of 3 months
- Having previously signed a written informed consent
- The patient must be covered by a social security system (in France)
- Pregnant or lactating women
- Men and women of childbearing potential not practicing an adequate method of contraception during the study treatment and at least 3 months after the last study drug administration
- Any history of cancer or cancer treatment during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma
- Uncontrolled infectious disease, including active HBV (hepatitis B virus) infection defined by either detection of HBs Antigen or presence of anti HBs antibody without detectable anti HBc antibody.
- HIV (Human immunodeficiency virus), HCV (hepatitis C virus) or HTLV (Human T-lymphotropic virus) serology positivity
- Abnormal liver (bilirubin > 2,5 N) function unless abnormalities are due to AHL 2011 Protocol Version n°1.2_ 09/02/11_approved on March 11, 2011 EudraCT n°2010-022844-19 4 / 73 Hodgkin lymphoma
- Abnormal renal (Creatinin > 150 μmol/L) function unless abnormalities are due to Hodgkin lymphoma
- Leukopenia < 2 G/l or thrombopenia <100 G/l unless abnormalities are due to Hodgkin lymphoma
- Severe cardio-pulmonary, or metabolic disease interfering with normal application of protocol treatment:
- Left Ejection Ventricular Fraction <50%
- Respiratory insufficiency prohibiting bleomycin use
- Uncontrolled diabetes mellitus leading to impossibility to perform PET scan
- Impossibility to perform a baseline PET (PET0) before randomization and treatment beginning
- Incapable person
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard arm BEACOPPesc Induction treatment: Patients will be treated by a BEACOPPesc regimen every 3 weeks for 4 cycles. A PET will be performed after 2 cycles of chemotherapy (PET2) with no decisional value, and after 4 cycles with decisional value. Consolidation treatment: depends on the reviewed PET4 result. In case of PET4 negative result, patient will received 2 additional cycles of BEACOPPesc, whatever the result of the PET2. In case of PET4 positive, the patient will be considered in treatment failure and proposed to a salvage therapy after pathologic confirmation of failure by biopsy of the hypermetabolic residual mass when possible. Experimental arm BEACOPPesc - ABVD - PET2 Induction treatment: Patients will be treated by a BEACOPPesc regimen every 3 weeks for 2 cycles followed by a PET scan (PET2). After PET2 central review: * In case of positive PET2, the induction treatment will be completed by 2 additional cycles of BEACOPPesc * In case of negative PET2, the induction treatment will be completed by 2 cycles of ABVD delivered every 4 weeks. The first cycle of ABVD will start at day 21 of the second cycle of BEACOPPesc. Consolidation treatment: depends on the reviewed PET4 result In case of PET4 negative result, consolidation treatment will depends on PET2 results: * If PET2 was positive, patient will received 2 additional cycles of BEACOPPesc delivered every 3 weeks * If PET2 was negative, patient will received 2 additional cycles of ABVD delivered every 4 weeks In case of PET4 positive, the patient will be considered as treatment failure.
- Primary Outcome Measures
Name Time Method Progression free survival 5 years Evaluate by PFS at 5 years the non-inferiority of a chemotherapy of a therapeutic strategy driven by PET with a ABVD conventional dose chemotherapy for patients reaching a negative PET after 2 cycles of BEACOPPesc, compared to a treatment not monitored by early PET delivering 6 cycles of BEACOPPesc.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (96)
CH Victor Dupouy
🇫🇷Argenteuil, France
Institut Bergonié
🇫🇷Bordeaux, France
Grand hôpital de Charleroi
🇧🇪Charleroi, Belgium
RHMS
🇧🇪Baudour, Belgium
CH Avignon - Hopital Duffaut
🇫🇷Avignon, France
Hôpital Morvan- CHU Brest
🇫🇷Brest, France
Ch Brive
🇫🇷Brive -la- Gaillarde, France
Clinique sud Luxembourg
🇧🇪Arlon, Belgium
CH de Bourg en Bresse
🇫🇷Bourg en Bresse, France
CHG Béziers
🇫🇷Béziers, France
CHU de Caen-Côte de Nacre
🇫🇷Caen, France
Hôpital de Chalon
🇫🇷Chalon sur saône, France
Hopital Henri Mondor
🇫🇷Créteil, France
CH Lens
🇫🇷Lens, France
CH Yves Le Foll
🇫🇷Saint Brieuc Cedex 1, France
Hopital Soint-Antoine
🇫🇷Paris, France
CH Meaux
🇫🇷Meaux, France
Clinique Mathilde
🇫🇷Rouen, France
Hôpital Erasme
🇧🇪Bruxelles, Belgium
Clinique St Joseph
🇧🇪Mons, Belgium
AZ Delta
🇧🇪Roeselare, Belgium
CHU Angers
🇫🇷Angers, France
CH Antibes
🇫🇷Antibes, France
CH d'Arras
🇫🇷Arras, France
Hopital de Bayonne
🇫🇷Bayonne, France
Polyclinique Bordeaux Nord Aquitaine
🇫🇷Bordeaux, France
CH du Dr Duchenne
🇫🇷Boulogne sur Mer, France
CH Jacques-Coeur
🇫🇷Bourges Cedex, France
Centre François Baclesse
🇫🇷Caen, France
Clinique du Parc
🇫🇷Castelnau-le-Lez, France
CH Chambéry
🇫🇷Chambéry, France
Hopital Antoine Beclere
🇫🇷Clamart, France
Hôpital d'instruction des Armées Percy
🇫🇷Clamart, France
CH Sud Francilien
🇫🇷Corbeil-Essonnes, France
CHU Dijon - Hopital du Bocage
🇫🇷Dijon, France
Chd Vendee
🇫🇷La Roche Sur Yon, France
Hopital Saint Louis
🇫🇷La Rochelle Cedex 1, France
CH de Versaille - Hopital Mignot
🇫🇷Le Chesnay, France
CH Chartres - Hopital Louis Pasteur
🇫🇷Le COUDRAY, France
Clinique Victor HUGO
🇫🇷Le Mans, France
CHU du Mans
🇫🇷Le Mans, France
Clinique de la Sauvegarde
🇫🇷Lyon Cedex, France
Institut Calmettes
🇫🇷Marseille, France
CRLC Val D'Aurelle
🇫🇷Montpellier, France
CH Mulhouse - Hopital Muller
🇫🇷Mulhouse, France
Centre Catherine de Sienne
🇫🇷Nantes Cedex, France
Institut Curie - Hopital Claudius Régaud
🇫🇷Paris, France
CHU Hotel Dieu
🇫🇷Nantes, France
Centre Antoine lacassagne
🇫🇷Nice, France
CHU Nice - Hopital de l'Archet
🇫🇷Nice, France
CHU Caremeau
🇫🇷Nimes, France
CHR de la Source
🇫🇷Orleans, France
Hopital Cochin
🇫🇷Paris Cedex 14, France
Hopital Saint-Louis
🇫🇷Paris, France
Hopital de la Pitié Salpétrière
🇫🇷Paris, France
Hôpital St Jean
🇫🇷Perpignan, France
CH de la région d'Annecy
🇫🇷Pringy, France
Institut de Cancérologie Lucien Neuwirth
🇫🇷St Priest en Jarez, France
CHU de Strasbourg-Hopital de Hautepierre
🇫🇷Strasbourg, France
Hopital Necker
🇫🇷Paris, France
Hopital de la conception
🇫🇷Marseille, France
Hopitaux Civil de Colmar - Hopital Pasteur
🇫🇷Colmar, France
CH de Dunkerque
🇫🇷Dunkerque, France
CHU de Limoge - Hopital Dupuytren
🇫🇷Limoges, France
Hopital Bicetre
🇫🇷Le Kremelin Bicetre, France
Chru Lille
🇫🇷Lille, France
Centre Léon Bérard
🇫🇷Lyon, France
CH Marc Jacquet
🇫🇷Melun, France
CHR Metz - Hopital Bon Secours
🇫🇷Metz, France
CHU Saint-Eloi
🇫🇷Montpellier, France
Hopital Américain de Paris
🇫🇷Neuilly sur Seine, France
Hôpital ST Antoine
🇫🇷Paris, France
CH de Pau
🇫🇷Pau Cedex, France
CHU Haut Leveque - Centre François Magendie
🇫🇷Pessac, France
Pontchaillou
🇫🇷Rennes, France
CHU Lyon Sud
🇫🇷Pierre Bénite, France
CH Dubos
🇫🇷Pontoise, France
CHU Reims - Hopital Robert Debré
🇫🇷Reims, France
Centre Henri Becquerel
🇫🇷Rouen, France
Institut Curie - Hopital Huguenin
🇫🇷Saint-Cloud, France
Hôpital Bretonneau
🇫🇷Tours, France
CH de Bretagne Atlantique
🇫🇷Vannes, France
Institut Gustave Roussy
🇫🇷Villejuif, France
CHU Brabois
🇫🇷Vandoeuvre les Nancy, France
CH de Troyes
🇫🇷Troyes, France
CH Valence
🇫🇷Valence, France
ZNA Stuivenberg
🇧🇪Antwerpen, Belgium
Az Sint Jan
🇧🇪Bruges, Belgium
Ucl Bruxelles
🇧🇪Bruxelles, Belgium
CH tourelle Peltzer
🇧🇪Verviers, Belgium
Chu Mont Godinne
🇧🇪Yvoir, Belgium
Centre Hospitalier Wallonie Picarde
🇧🇪Tournai, Belgium
Hôpital Jolimont
🇧🇪Haine ST Paul, Belgium
AZ Groeninge
🇧🇪Kortrljk, Belgium
chu Ambroise Paré
🇧🇪Mons, Belgium
Clinique ST Pierre
🇧🇪Ottignies, Belgium