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 (AHL 2011)
This study is currently recruiting participants.
Verified January 2013 by Centre Hospitalier Universitaire Dijon
Sponsor:
Centre Hospitalier Universitaire Dijon
Collaborator:
The Lymphoma Study Association
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT01358747
First received: May 11, 2011
Last updated: January 4, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hodgkin's Lymphoma |
Drug: BEACOPPesc Drug: BEACOPPesc - ABVD - PET2 |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment |
| Official Title: | Randomized Phase III Study of a Treatment Driven by Early PET Response Compared to a Treatment Not Monitored by Early PET in Patients With Ann Arbor Stage III-IV or High Risk IIB Hodgkin Lymphoma |
Resource links provided by NLM:
Further study details as provided by Centre Hospitalier Universitaire Dijon:
Primary Outcome Measures:
- Progression free survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]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.
| Study Start Date: | May 2011 |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Standard arm
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.
|
Drug: BEACOPPesc |
|
Experimental: Experimental arm
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:
Consolidation treatment: depends on the reviewed PET4 result In case of PET4 negative result, consolidation treatment will depends on PET2 results:
|
Drug: BEACOPPesc - ABVD - PET2 |
Eligibility| Ages Eligible for Study: | 16 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01358747
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Contacts
| Contact: Stéphanie PICARD | 4 72 66 93 33 ext 33 | stephanie.picard@lysarc.org |
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| Belgium | |
| ZNA Stuivenberg | Recruiting |
| Antwerpen, Belgium, 2060 | |
| Principal Investigator: Pierre ZACHEE | |
| Clinique sud Luxembourg | Recruiting |
| Arlon, Belgium, 6700 | |
| Principal Investigator: Pascal Pierre | |
| RHMS | Recruiting |
| Baudour, Belgium, 7331 | |
| Principal Investigator: Anne De WEWEIRE | |
| Az Sint Jan | Recruiting |
| Bruges, Belgium, 8000 | |
| Principal Investigator: Achiel VAN HOOF | |
| Hôpital Erasme | Recruiting |
| Bruxelles, Belgium, 1070 | |
| Principal Investigator: Virginie De WILDE | |
| Ucl Bruxelles | Recruiting |
| Bruxelles, Belgium, 1200 | |
| Principal Investigator: Eric VAN DEN NESTE | |
| Grand hôpital de Charleroi | Recruiting |
| Charleroi, Belgium, 6000 | |
| Principal Investigator: Delphine PRANGER | |
| AZ Groeninge | Recruiting |
| Kortrljk, Belgium, 8500 | |
| Principal Investigator: Koenraad VAN EYGEN | |
| Clinique St Joseph | Recruiting |
| Mons, Belgium, 7000 | |
| Contact: Dominique Boulet | |
| Principal Investigator: Dominique Boulet | |
| chu Ambroise Paré | Recruiting |
| Mons, Belgium, 7000 | |
| Principal Investigator: Valérie ROBIN | |
| Clinique ST Pierre | Recruiting |
| Ottignies, Belgium, 1340 | |
| Principal Investigator: Thierry CONNEROTTE | |
| Centre Hospitalier Wallonie Picarde | Recruiting |
| Tournai, Belgium, 7500 | |
| Principal Investigator: Khalil KARGAR SAMANI | |
| CH tourelle Peltzer | Recruiting |
| Verviers, Belgium, 4800 | |
| Principal Investigator: Pascale FRERE | |
| Chu Mont Godinne | Recruiting |
| Yvoir, Belgium, 5530 | |
| Contact: Marc ANDRE | |
| Principal Investigator: Marc André | |
| France | |
| CHU Angers | Recruiting |
| Angers, France, 49033 | |
| Principal Investigator: Marie Pierre MOLES | |
| CH Antibes | Recruiting |
| Antibes, France, 06606 | |
| Principal Investigator: Daniel RE | |
| CH Victor Dupouy | Recruiting |
| Argenteuil, France, 95107 | |
| Principal Investigator: Laurent SUTTON | |
| CH d'Arras | Recruiting |
| Arras, France, 62022 | |
| Principal Investigator: Pauline LIONNE-HUYGHE | |
| CH Avignon - Hopital Duffaut | Recruiting |
| Avignon, France, 84902 | |
| Principal Investigator: Olivier BOULAT | |
| Hopital de Bayonne | Recruiting |
| Bayonne, France, 64100 | |
| Principal Investigator: Carla ARAUJO | |
| Polyclinique Bordeaux Nord Aquitaine | Recruiting |
| Bordeaux, France, 33077 | |
| Principal Investigator: Olivier FITOUSSI | |
| CH du Dr Duchenne | Recruiting |
| Boulogne sur Mer, France, 62200 | |
| Principal Investigator: Bachra CHOUFI | |
| CH de Bourg en Bresse | Recruiting |
| Bourg en Bresse, France, 01012 | |
| Principal Investigator: Hubert ORFEUVRE | |
| Hôpital Morvan- CHU Brest | Recruiting |
| Brest, France, 29609 | |
| Principal Investigator: Adrian TEMPESCUL | |
| Ch Brive | Recruiting |
| Brive -la- Gaillarde, France, 19312 | |
| Principal Investigator: Sophie LEFORT | |
| CHG Béziers | Recruiting |
| Béziers, France, 34500 | |
| Principal Investigator: Alain SAAD | |
| CHU de Caen-Côte de Nacre | Recruiting |
| Caen, France, 14000 | |
| Principal Investigator: Oumédaly REMAN | |
| Centre François Baclesse | Recruiting |
| Caen, France, 14076 | |
| Principal Investigator: Christophe FRUCHART | |
| Hôpital de Chalon | Recruiting |
| Chalon sur saône, France, 71100 | |
| Principal Investigator: Bruno SALLES | |
| CH Chambéry | Recruiting |
| Chambéry, France, 73000 | |
| Principal Investigator: Delphine SENECAL | |
| Hopital Antoine Beclere | Recruiting |
| Clamart, France, 92140 | |
| Principal Investigator: François BOUE | |
| Hôpital d'instruction des Armées Percy | Recruiting |
| Clamart, France, 92141 | |
| Principal Investigator: Bertrand SOULEAU | |
| Hopitaux Civil de Colmar - Hopital Pasteur | Recruiting |
| Colmar, France, 68024 | |
| Principal Investigator: Mohammed BELKAID | |
| Ch de Compiègne | Recruiting |
| Compiègne, France, 60321 | |
| Principal Investigator: Phillippe NACCAHE | |
| CH Sud Francilien | Recruiting |
| Corbeil-Essonnes, France, 91106 | |
| Principal Investigator: Bertrand JOLY | |
| Hopital Henri Mondor | Recruiting |
| Créteil, France, 94010 | |
| Principal Investigator: Corinne HAIOUN | |
| CHU Dijon - Hopital du Bocage | Recruiting |
| Dijon, France, 21079 | |
| Principal Investigator: Olivier CASASNONAS | |
| CH de Dunkerque | Recruiting |
| Dunkerque, France, 59385 | |
| Principal Investigator: Jean-Michel PIGNON | |
| Hôpital Jolimont | Recruiting |
| Haine ST Paul, France, 7100 | |
| Principal Investigator: Nicole STRAETMANS | |
| Chd Vendee | Recruiting |
| La Roche Sur Yon, France, 85925 | |
| Principal Investigator: Hervé MAISONNEUVE | |
| CH de Versaille - Hopital Mignot | Recruiting |
| Le Chesnay, France, 78157 | |
| Principal Investigator: Sylvie CASTAIGNE | |
| CH Chartres - Hopital Louis Pasteur | Recruiting |
| Le COUDRAY, France, 28630 | |
| Principal Investigator: Lina AL JASSEM | |
| Hopital Bicetre | Recruiting |
| Le Kremelin Bicetre, France, 94275 | |
| Principal Investigator: Caroline BESSON | |
| CHU du Mans | Recruiting |
| Le Mans, France, 72037 | |
| Principal Investigator: Kamel LARIBI | |
| CH Lens | Recruiting |
| Lens, France, 62307 | |
| Principal Investigator: Marjan ERTAULT | |
| Chru Lille | Recruiting |
| Lille, France, 59037 | |
| Principal Investigator: Franck MORSCHHAUSER | |
| CHU de Limoge - Hopital Dupuytren | Recruiting |
| Limoges, France, 87042 | |
| Principal Investigator: Dominique BORDESSOULE | |
| Centre Léon Bérard | Recruiting |
| Lyon, France, 69373 | |
| Principal Investigator: Catherine SEBBAN | |
| Hopital des Chanaux | Recruiting |
| Macon, France, 71018 | |
| Principal Investigator: Amine BELHABRI | |
| Institut Calmettes | Recruiting |
| Marseille, France, 13273 | |
| Principal Investigator: Réda BOUABDALLAH | |
| Hopital de la conception | Recruiting |
| Marseille, France, 13385 | |
| Principal Investigator: Régis COSTELLO | |
| CH Meaux | Recruiting |
| Meaux, France, 77100 | |
| Principal Investigator: Wajed ABARAH | |
| CH Marc Jacquet | Recruiting |
| Melun, France, 77011 | |
| Principal Investigator: Claire KULEKCI | |
| CHR Metz - Hopital Bon Secours | Recruiting |
| Metz, France, 57038 | |
| Principal Investigator: Bernard CHRISTIAN | |
| CRLC Val D'Aurelle | Recruiting |
| Montpellier, France, 34298 | |
| Principal Investigator: Michel FABBRO | |
| Centre Azuréen de Cancérologie | Recruiting |
| Mougins, France, 06250 | |
| Principal Investigator: Hervé NAMAN | |
| CH Mulhouse - Hopital Muller | Recruiting |
| Mulhouse, France, 68070 | |
| Principal Investigator: Jean-Claude EISENMANN | |
| CHU Hotel Dieu | Recruiting |
| Nantes, France, 44093 | |
| Principal Investigator: Thomas GASTINNE | |
| Hopital Américain de Paris | Recruiting |
| Neuilly sur Seine, France, 92200 | |
| Principal Investigator: Patrice CARDE | |
| Centre Antoine lacassagne | Recruiting |
| Nice, France, 06189 | |
| Principal Investigator: Antoine THYSS | |
| CHU Nice - Hopital de l'Archet | Recruiting |
| Nice, France, 06202 | |
| Principal Investigator: Jean-Michel KARSENTI | |
| CHU Caremeau | Recruiting |
| Nimes, France, 30029 | |
| Principal Investigator: Pascal BOURQUARD | |
| CHR de la Source | Recruiting |
| Orleans, France, 45067 | |
| Principal Investigator: Magda ALEXIS | |
| Hopital Saint-Louis | Recruiting |
| Paris, France, 75475 | |
| Principal Investigator: Pauline BRICE | |
| Hopital de la Pitié Salpétrière | Recruiting |
| Paris, France, 75651 | |
| Principal Investigator: Jean GABARRE | |
| Hôpital ST Antoine | Recruiting |
| Paris, France, 75012 | |
| Principal Investigator: Zora MARJANOVIC | |
| Institut Curie - Hopital Claudius Régaud | Recruiting |
| Paris, France, 75248 | |
| Principal Investigator: Frédérique KHUNOWSKI | |
| Hopital Soint-Antoine | Recruiting |
| Paris, France, 75012 | |
| Principal Investigator: Malek AOUDJHANE | |
| Hopital Necker | Recruiting |
| Paris, France, 75743 | |
| Principal Investigator: Richard DELARUE | |
| Hôpital St Jean | Recruiting |
| Perpignan, France, 66046 | |
| Principal Investigator: Laurence SANHES | |
| CHU Haut Leveque - Centre François Magendie | Recruiting |
| Pessac, France, 33600 | |
| Principal Investigator: Kamal BOUABDALLAH | |
| CHU Lyon Sud | Recruiting |
| Pierre Bénite, France, 69495 | |
| Principal Investigator: Gilles SALLES | |
| CH Dubos | Recruiting |
| Pontoise, France, 95300 | |
| Principal Investigator: Hugo GONZALES | |
| CH de la région d'Annecy | Recruiting |
| Pringy, France, 74370 | |
| Principal Investigator: Anne PARRY | |
| Institut du cancer de Courlancy | Recruiting |
| Reims, France, 51100 | |
| Principal Investigator: Philippe COLIN | |
| CHU Reims - Hopital Robert Debré | Recruiting |
| Reims, France, 51092 | |
| Principal Investigator: Alain DELMER | |
| Pontchaillou | Recruiting |
| Rennes, France, 35033 | |
| Principal Investigator: Thierry LAMY DE LA CHAPELLE | |
| Clinique Mathilde | Recruiting |
| Rouen, France, 76100 | |
| Principal Investigator: Nicolas ALBIN | |
| Centre Henri Becquerel | Recruiting |
| Rouen, France, 76000 | |
| Principal Investigator: Aspasia STAMATOULAS | |
| Institut Curie - Hopital Huguenin | Recruiting |
| Saint-Cloud, France, 92210 | |
| Principal Investigator: Maud JANVIER | |
| CHI Toulon-Hôpital Font Pré | Recruiting |
| Toulon, France, 83056 | |
| Principal Investigator: Claudine SOHN | |
| Hôpital Bretonneau | Recruiting |
| Tours, France, 37044 | |
| Principal Investigator: Cristina PRECUPANU | |
| CH de Troyes | Recruiting |
| Troyes, France, 10003 | |
| Principal Investigator: Nadia ALI AMMAR | |
| CH Valence | Recruiting |
| Valence, France, 26953 | |
| Principal Investigator: Bruno ANGLARET | |
| CHU Brabois | Recruiting |
| Vandoeuvre les Nancy, France, 54511 | |
| Principal Investigator: Serge BOLOGNA | |
| Institut Gustave Roussy | Recruiting |
| Villejuif, France, 94805 | |
| Principal Investigator: Christophe FERME | |
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
The Lymphoma Study Association
Investigators
| Principal Investigator: | René-Olivier CASASNOVAS, MD | CHU Dijon |
More Information
No publications provided
| Responsible Party: | Centre Hospitalier Universitaire Dijon |
| ClinicalTrials.gov Identifier: | NCT01358747 History of Changes |
| Other Study ID Numbers: | Casasnovas PHRC N 2010 |
| Study First Received: | May 11, 2011 |
| Last Updated: | January 4, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Belgium: Federal Agency for Medicinal Products and Health Products |
Additional relevant MeSH terms:
|
Hodgkin Disease Lymphoma Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013