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
NCT ID: NCT01358747
Last Updated: 2014-05-21
Study Results
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Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
2011-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
Study Groups
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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.
BEACOPPesc
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:
* 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.
BEACOPPesc - ABVD - PET2
Interventions
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BEACOPPesc
BEACOPPesc - ABVD - PET2
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
16 Years
60 Years
ALL
No
Sponsors
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The Lymphoma Study Association
UNKNOWN
Centre Hospitalier Universitaire Dijon
OTHER
Responsible Party
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Principal Investigators
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René-Olivier CASASNOVAS, MD
Role: PRINCIPAL_INVESTIGATOR
CHU Dijon
Locations
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ZNA Stuivenberg
Antwerp, , Belgium
Clinique sud Luxembourg
Arlon, , Belgium
RHMS
Baudour, , Belgium
Az Sint Jan
Bruges, , Belgium
Hôpital Erasme
Brussels, , Belgium
Ucl Bruxelles
Brussels, , Belgium
Grand hôpital de Charleroi
Charleroi, , Belgium
Hôpital Jolimont
Haine-Saint-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, , Belgium
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, , France
Hôpital Morvan- CHU Brest
Brest, , France
Ch Brive
Brive-la-Gaillarde, , France
CHU de Caen-Côte de Nacre
Caen, , France
Centre François Baclesse
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
Dunkirk, , France
Chd Vendee
La Roche-sur-Yon, , France
Hopital Saint Louis
La Rochelle, , France
CH de Versaille - Hopital Mignot
Le Chesnay, , France
CH Chartres - Hopital Louis Pasteur
Le Coudray, , France
Hopital Bicetre
Le Kremelin Bicetre, , France
Clinique Victor HUGO
Le Mans, , France
CHU du Mans
Le Mans, , France
CH Lens
Lens, , France
Chru Lille
Lille, , France
CHU de Limoge - Hopital Dupuytren
Limoges, , France
Clinique de la Sauvegarde
Lyon, , France
Centre Léon Bérard
Lyon, , France
Institut Calmettes
Marseille, , France
Hopital de la conception
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
Centre Catherine de Sienne
Nantes, , France
CHU Hotel Dieu
Nantes, , France
Hopital Américain de Paris
Neuilly-sur-Seine, , France
Centre Antoine lacassagne
Nice, , France
CHU Nice - Hopital de l'Archet
Nice, , France
CHU Caremeau
Nîmes, , France
CHR de la Source
Orléans, , France
Hopital Soint-Antoine
Paris, , France
Hôpital ST Antoine
Paris, , France
Institut Curie - Hopital Claudius Régaud
Paris, , France
Hopital Saint-Louis
Paris, , France
Hopital de la Pitié Salpétrière
Paris, , France
Hopital Cochin
Paris, , France
Hopital Necker
Paris, , France
CH de Pau
Pau, , 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, , France
Institut Curie - Hopital Huguenin
Saint-Cloud, , France
Institut de Cancérologie Lucien Neuwirth
Saint-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
Vandœuvre-lès-Nancy, , France
CH de Bretagne Atlantique
Vannes, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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References
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Kreuzberger N, Goldkuhle M, von Tresckow B, Kobe C, Sickinger MT, Monsef I, Skoetz N. Positron emission tomography-adapted therapy for first-line treatment in adults with Hodgkin lymphoma. Cochrane Database Syst Rev. 2025 Mar 26;3(3):CD010533. doi: 10.1002/14651858.CD010533.pub3.
Casasnovas RO, Bouabdallah R, Brice P, Lazarovici J, Ghesquieres H, Stamatoullas A, Dupuis J, Gac AC, Gastinne T, Joly B, Bouabdallah K, Nicolas-Virelizier E, Feugier P, Morschhauser F, Sibon D, Bonnet C, Berriolo-Riedinger A, Edeline V, Parrens M, Damotte D, Coso D, Andre M, Meignan M, Rossi C. Positron Emission Tomography-Driven Strategy in Advanced Hodgkin Lymphoma: Prolonged Follow-Up of the AHL2011 Phase III Lymphoma Study Association Study. J Clin Oncol. 2022 Apr 1;40(10):1091-1101. doi: 10.1200/JCO.21.01777. Epub 2022 Jan 6.
Demeestere I, Racape J, Dechene J, Dupuis J, Morschhauser F, De Wilde V, Lazarovici J, Ghesquieres H, Touati M, Sibon D, Alexis M, Gac AC, Moatti H, Virelizier E, Maisonneuve H, Pranger D, Houot R, Fornecker LM, Tempescul A, Andre M, Casasnovas RO. Gonadal Function Recovery in Patients With Advanced Hodgkin Lymphoma Treated With a PET-Adapted Regimen: Prospective Analysis of a Randomized Phase III Trial (AHL2011). J Clin Oncol. 2021 Oct 10;39(29):3251-3260. doi: 10.1200/JCO.21.00068. Epub 2021 Jun 22.
Casasnovas RO, Bouabdallah R, Brice P, Lazarovici J, Ghesquieres H, Stamatoullas A, Dupuis J, Gac AC, Gastinne T, Joly B, Bouabdallah K, Nicolas-Virelizier E, Feugier P, Morschhauser F, Delarue R, Farhat H, Quittet P, Berriolo-Riedinger A, Tempescul A, Edeline V, Maisonneuve H, Fornecker LM, Lamy T, Delmer A, Dartigues P, Martin L, Andre M, Mounier N, Traverse-Glehen A, Meignan M. PET-adapted treatment for newly diagnosed advanced Hodgkin lymphoma (AHL2011): a randomised, multicentre, non-inferiority, phase 3 study. Lancet Oncol. 2019 Feb;20(2):202-215. doi: 10.1016/S1470-2045(18)30784-8. Epub 2019 Jan 15.
Other Identifiers
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Casasnovas PHRC N 2010
Identifier Type: -
Identifier Source: org_study_id
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