AHL 2011: 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

Sponsor

Centre Hospitalier Universitaire Dijon (Other)

Overall Status

Completed

CT.gov ID

NCT01358747

Collaborator

The Lymphoma Study Association (Other)

Locations

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hodgkin's Lymphoma	Drug: BEACOPPesc Drug: BEACOPPesc - ABVD - PET2	Phase 3

Study Design

Study Type:

Interventional

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

Study Start Date :

May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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: 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.	Drug: BEACOPPesc - ABVD - PET2

Arm

Intervention/Treatment

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: 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.

Drug: BEACOPPesc - ABVD - PET2

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	ZNA Stuivenberg	Antwerpen	Belgium	2060
2	Clinique sud Luxembourg	Arlon	Belgium	6700
3	RHMS	Baudour	Belgium	7331
4	Az Sint Jan	Bruges	Belgium	8000
5	Hôpital Erasme	Bruxelles	Belgium	1070
6	Ucl Bruxelles	Bruxelles	Belgium	1200
7	Grand hôpital de Charleroi	Charleroi	Belgium	6000
8	Hôpital Jolimont	Haine ST Paul	Belgium	7100
9	AZ Groeninge	Kortrljk	Belgium	8500
10	chu Ambroise Paré	Mons	Belgium	7000
11	Clinique St Joseph	Mons	Belgium	7000
12	Clinique ST Pierre	Ottignies	Belgium	1340
13	AZ Delta	Roeselare	Belgium	8800
14	Centre Hospitalier Wallonie Picarde	Tournai	Belgium	7500
15	CH tourelle Peltzer	Verviers	Belgium	4800
16	Chu Mont Godinne	Yvoir	Belgium	5530
17	CHU Angers	Angers	France	49033
18	CH Antibes	Antibes	France	06606
19	CH Victor Dupouy	Argenteuil	France	95107
20	CH d'Arras	Arras	France	62022
21	CH Avignon - Hopital Duffaut	Avignon	France	84902
22	Hopital de Bayonne	Bayonne	France	64100
23	Institut Bergonié	Bordeaux	France	33076
24	Polyclinique Bordeaux Nord Aquitaine	Bordeaux	France	33077
25	CH du Dr Duchenne	Boulogne sur Mer	France	62200
26	CH de Bourg en Bresse	Bourg en Bresse	France	01012
27	CH Jacques-Coeur	Bourges Cedex	France	18020
28	Hôpital Morvan- CHU Brest	Brest	France	29609
29	Ch Brive	Brive -la- Gaillarde	France	19312
30	CHG Béziers	Béziers	France	34500
31	CHU de Caen-Côte de Nacre	Caen	France	14000
32	Centre François Baclesse	Caen	France	14076
33	Clinique du Parc	Castelnau-le-Lez	France	34170
34	Hôpital de Chalon	Chalon sur saône	France	71100
35	CH Chambéry	Chambéry	France	73000
36	Hopital Antoine Beclere	Clamart	France	92140
37	Hôpital d'instruction des Armées Percy	Clamart	France	92141
38	Hopitaux Civil de Colmar - Hopital Pasteur	Colmar	France	68024
39	CH Sud Francilien	Corbeil-Essonnes	France	91106
40	Hopital Henri Mondor	Créteil	France	94010
41	CHU Dijon - Hopital du Bocage	Dijon	France	21079
42	CH de Dunkerque	Dunkerque	France	59385
43	Chd Vendee	La Roche Sur Yon	France	85925
44	Hopital Saint Louis	La Rochelle Cedex 1	France	17019
45	CH de Versaille - Hopital Mignot	Le Chesnay	France	78157
46	CH Chartres - Hopital Louis Pasteur	Le COUDRAY	France	28630
47	Hopital Bicetre	Le Kremelin Bicetre	France	94275
48	Clinique Victor HUGO	Le Mans	France	72015
49	CHU du Mans	Le Mans	France	72037
50	CH Lens	Lens	France	62307
51	Chru Lille	Lille	France	59037
52	CHU de Limoge - Hopital Dupuytren	Limoges	France	87042
53	Clinique de la Sauvegarde	Lyon Cedex	France	69337
54	Centre Léon Bérard	Lyon	France	69373
55	Institut Calmettes	Marseille	France	13273
56	Hopital de la conception	Marseille	France	13385
57	CH Meaux	Meaux	France	77100
58	CH Marc Jacquet	Melun	France	77011
59	CHR Metz - Hopital Bon Secours	Metz	France	57038
60	CHU Saint-Eloi	Montpellier	France	34295
61	CRLC Val D'Aurelle	Montpellier	France	34298
62	CH Mulhouse - Hopital Muller	Mulhouse	France	68070
63	Centre Catherine de Sienne	Nantes Cedex	France	44000
64	CHU Hotel Dieu	Nantes	France	44093
65	Hopital Américain de Paris	Neuilly sur Seine	France	92200
66	Centre Antoine lacassagne	Nice	France	06189
67	CHU Nice - Hopital de l'Archet	Nice	France	06202
68	CHU Caremeau	Nimes	France	30029
69	CHR de la Source	Orleans	France	45067
70	Hopital Cochin	Paris Cedex 14	France	75679
71	Hopital Soint-Antoine	Paris	France	75012
72	Hôpital ST Antoine	Paris	France	75012
73	Institut Curie - Hopital Claudius Régaud	Paris	France	75248
74	Hopital Saint-Louis	Paris	France	75475
75	Hopital de la Pitié Salpétrière	Paris	France	75651
76	Hopital Necker	Paris	France	75743
77	CH de Pau	Pau Cedex	France	64046
78	Hôpital St Jean	Perpignan	France	66046
79	CHU Haut Leveque - Centre François Magendie	Pessac	France	33600
80	CHU Lyon Sud	Pierre Bénite	France	69495
81	CH Dubos	Pontoise	France	95300
82	CH de la région d'Annecy	Pringy	France	74370
83	CHU Reims - Hopital Robert Debré	Reims	France	51092
84	Pontchaillou	Rennes	France	35033
85	Centre Henri Becquerel	Rouen	France	76000
86	Clinique Mathilde	Rouen	France	76100
87	CH Yves Le Foll	Saint Brieuc Cedex 1	France	22027
88	Institut Curie - Hopital Huguenin	Saint-Cloud	France	92210
89	Institut de Cancérologie Lucien Neuwirth	St Priest en Jarez	France	42271
90	CHU de Strasbourg-Hopital de Hautepierre	Strasbourg	France	67200
91	Hôpital Bretonneau	Tours	France	37044
92	CH de Troyes	Troyes	France	10003
93	CH Valence	Valence	France	26953
94	CHU Brabois	Vandoeuvre les Nancy	France	54511
95	CH de Bretagne Atlantique	Vannes	France	56017
96	Institut Gustave Roussy	Villejuif	France	94805

Sponsors and Collaborators

Centre Hospitalier Universitaire Dijon
The Lymphoma Study Association

Investigators

Principal Investigator: René-Olivier CASASNOVAS, MD, CHU Dijon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire Dijon

ClinicalTrials.gov Identifier:

NCT01358747

Other Study ID Numbers:

Casasnovas PHRC N 2010

First Posted:

May 24, 2011

Last Update Posted:

May 21, 2014

Last Verified:

Jan 1, 2013

Additional relevant MeSH terms:

Lymphoma

Hodgkin Disease

Study Results

No Results Posted as of May 21, 2014