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

Hodgkin's Lymphoma Clinical Trial

— AHL 2011  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01358747
• Other study ID #: Casasnovas PHRC N 2010
• Status: Completed
• Phase: Phase 3
• First received: May 11, 2011
• Last updated: May 20, 2014
• Start date: May 2011

Study information

• Verified date: January 2013
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin's Lymphoma

Intervention

Drug:
• BEACOPPesc

• BEACOPPesc - ABVD - PET2

Locations

Country	Name	City	State
Belgium	ZNA Stuivenberg	Antwerpen
Belgium	Clinique sud Luxembourg	Arlon
Belgium	RHMS	Baudour
Belgium	Az Sint Jan	Bruges
Belgium	Hôpital Erasme	Bruxelles
Belgium	Ucl Bruxelles	Bruxelles
Belgium	Grand hôpital de Charleroi	Charleroi
Belgium	Hôpital Jolimont	Haine ST Paul
Belgium	AZ Groeninge	Kortrljk
Belgium	chu Ambroise Paré	Mons
Belgium	Clinique St Joseph	Mons
Belgium	Clinique ST Pierre	Ottignies
Belgium	AZ Delta	Roeselare
Belgium	Centre Hospitalier Wallonie Picarde	Tournai
Belgium	CH tourelle Peltzer	Verviers
Belgium	Chu Mont Godinne	Yvoir
France	CHU Angers	Angers
France	CH Antibes	Antibes
France	CH Victor Dupouy	Argenteuil
France	CH d'Arras	Arras
France	CH Avignon - Hopital Duffaut	Avignon
France	Hopital de Bayonne	Bayonne
France	CHG Béziers	Béziers
France	Institut Bergonié	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	CH Jacques-Coeur	Bourges Cedex
France	Hôpital Morvan- CHU Brest	Brest
France	Ch Brive	Brive -la- Gaillarde
France	Centre François Baclesse	Caen
France	CHU de Caen-Côte de Nacre	Caen
France	Clinique du Parc	Castelnau-le-Lez
France	Hôpital de Chalon	Chalon sur saône
France	CH Chambéry	Chambéry
France	Hopital Antoine Beclere	Clamart
France	Hôpital d'instruction des Armées Percy	Clamart
France	Hopitaux Civil de Colmar - Hopital Pasteur	Colmar
France	CH Sud Francilien	Corbeil-Essonnes
France	Hopital Henri Mondor	Créteil
France	CHU Dijon - Hopital du Bocage	Dijon
France	CH de Dunkerque	Dunkerque
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	Hopital Bicetre	Le Kremelin Bicetre
France	CHU du Mans	Le Mans
France	Clinique Victor HUGO	Le Mans
France	CH Lens	Lens
France	Chru Lille	Lille
France	CHU de Limoge - Hopital Dupuytren	Limoges
France	Centre Léon Bérard	Lyon
France	Clinique de la Sauvegarde	Lyon Cedex
France	Hopital de la conception	Marseille
France	Institut Calmettes	Marseille
France	CH Meaux	Meaux
France	CH Marc Jacquet	Melun
France	CHR Metz - Hopital Bon Secours	Metz
France	CHU Saint-Eloi	Montpellier
France	CRLC Val D'Aurelle	Montpellier
France	CH Mulhouse - Hopital Muller	Mulhouse
France	CHU Hotel Dieu	Nantes
France	Centre Catherine de Sienne	Nantes Cedex
France	Hopital Américain de Paris	Neuilly sur Seine
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 de la Pitié Salpétrière	Paris
France	Hopital Necker	Paris
France	Hopital Saint-Louis	Paris
France	Hopital Soint-Antoine	Paris
France	Hôpital ST Antoine	Paris
France	Institut Curie - Hopital Claudius Régaud	Paris
France	Hopital Cochin	Paris Cedex 14
France	CH de Pau	Pau Cedex
France	Hôpital St Jean	Perpignan
France	CHU Haut Leveque - Centre François Magendie	Pessac
France	CHU Lyon Sud	Pierre Bénite
France	CH Dubos	Pontoise
France	CH de la région d'Annecy	Pringy
France	CHU Reims - Hopital Robert Debré	Reims
France	Pontchaillou	Rennes
France	Centre Henri Becquerel	Rouen
France	Clinique Mathilde	Rouen
France	CH Yves Le Foll	Saint Brieuc Cedex 1
France	Institut Curie - Hopital Huguenin	Saint-Cloud
France	Institut de Cancérologie Lucien Neuwirth	St Priest en Jarez
France	CHU de Strasbourg-Hopital de Hautepierre	Strasbourg
France	Hôpital Bretonneau	Tours
France	CH de Troyes	Troyes
France	CH Valence	Valence
France	CHU Brabois	Vandoeuvre les Nancy
France	CH de Bretagne Atlantique	Vannes
France	Institut Gustave Roussy	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon	The Lymphoma Study Association

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival	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.	5 years	Yes