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Hodgkin's LymphomaPhase 3AHL 2011NCT01358747

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

A Phase 3 study testing BEACOPPesc and BEACOPPesc - ABVD - PET2 in people with Hodgkin's Lymphoma, run by Centre Hospitalier Universitaire Dijon at 96 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 16 to 60 years
Conditions the study is for
Hodgkin's Lymphoma
What is being tested?
BEACOPPesc and BEACOPPesc - ABVD - PET2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
Not given
Where
96 sitesin 2 countries
Study dates
May 2011to not given
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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)

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

96 sites in 2 countries.

96 sites in 2 countries

France80 sites

  • CHU Angers

    Angers, 49033

  • CH Antibes

    Antibes, 06606

  • CH Victor Dupouy

    Argenteuil, 95107

  • CH d'Arras

    Arras, 62022

  • CH Avignon - Hopital Duffaut

    Avignon, 84902

  • Hopital de Bayonne

    Bayonne, 64100

  • CHG Béziers

    Béziers, 34500

  • Institut Bergonié

    Bordeaux, 33076

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33077

  • CH du Dr Duchenne

    Boulogne-sur-Mer, 62200

  • CH de Bourg en Bresse

    Bourg-en-Bresse, 01012

  • CH Jacques-Coeur

    Bourges, 18020

  • Hôpital Morvan- CHU Brest

    Brest, 29609

  • Ch Brive

    Brive-la-Gaillarde, 19312

  • CHU de Caen-Côte de Nacre

    Caen, 14000

  • Centre François Baclesse

    Caen, 14076

  • Clinique du Parc

    Castelnau-le-Lez, 34170

  • Hôpital de Chalon

    Chalon-sur-Saône, 71100

  • CH Chambéry

    Chambéry, 73000

  • Hopital Antoine Beclere

    Clamart, 92140

  • Hôpital d'instruction des Armées Percy

    Clamart, 92141

  • Hopitaux Civil de Colmar - Hopital Pasteur

    Colmar, 68024

  • CH Sud Francilien

    Corbeil-Essonnes, 91106

  • Hopital Henri Mondor

    Créteil, 94010

  • CHU Dijon - Hopital du Bocage

    Dijon, 21079

  • CH de Dunkerque

    Dunkirk, 59385

  • Chd Vendee

    La Roche-sur-Yon, 85925

  • Hopital Saint Louis

    La Rochelle, 17019

  • CH de Versaille - Hopital Mignot

    Le Chesnay, 78157

  • CH Chartres - Hopital Louis Pasteur

    Le Coudray, 28630

  • Hopital Bicetre

    Le Kremelin Bicetre, 94275

  • Clinique Victor HUGO

    Le Mans, 72015

  • CHU du Mans

    Le Mans, 72037

  • CH Lens

    Lens, 62307

  • Chru Lille

    Lille, 59037

  • CHU de Limoge - Hopital Dupuytren

    Limoges, 87042

  • Clinique de la Sauvegarde

    Lyon, 69337

  • Centre Léon Bérard

    Lyon, 69373

  • Institut Calmettes

    Marseille, 13273

  • Hopital de la conception

    Marseille, 13385

  • CH Meaux

    Meaux, 77100

  • CH Marc Jacquet

    Melun, 77011

  • CHR Metz - Hopital Bon Secours

    Metz, 57038

  • CHU Saint-Eloi

    Montpellier, 34295

  • CRLC Val D'Aurelle

    Montpellier, 34298

  • CH Mulhouse - Hopital Muller

    Mulhouse, 68070

  • Centre Catherine de Sienne

    Nantes, 44000

  • CHU Hotel Dieu

    Nantes, 44093

  • Hopital Américain de Paris

    Neuilly-sur-Seine, 92200

  • Centre Antoine lacassagne

    Nice, 06189

  • CHU Nice - Hopital de l'Archet

    Nice, 06202

  • CHU Caremeau

    Nîmes, 30029

  • CHR de la Source

    Orléans, 45067

  • Hopital Soint-Antoine

    Paris, 75012

  • Hôpital ST Antoine

    Paris, 75012

  • Institut Curie - Hopital Claudius Régaud

    Paris, 75248

  • Hopital Saint-Louis

    Paris, 75475

  • Hopital de la Pitié Salpétrière

    Paris, 75651

  • Hopital Cochin

    Paris, 75679

  • Hopital Necker

    Paris, 75743

  • CH de Pau

    Pau, 64046

  • Hôpital St Jean

    Perpignan, 66046

  • CHU Haut Leveque - Centre François Magendie

    Pessac, 33600

  • CHU Lyon Sud

    Pierre-Bénite, 69495

  • CH Dubos

    Pontoise, 95300

  • CH de la région d'Annecy

    Pringy, 74370

  • CHU Reims - Hopital Robert Debré

    Reims, 51092

  • Pontchaillou

    Rennes, 35033

  • Centre Henri Becquerel

    Rouen, 76000

  • Clinique Mathilde

    Rouen, 76100

  • CH Yves Le Foll

    Saint-Brieuc, 22027

  • Institut Curie - Hopital Huguenin

    Saint-Cloud, 92210

  • Institut de Cancérologie Lucien Neuwirth

    Saint-Priest-en-Jarez, 42271

  • CHU de Strasbourg-Hopital de Hautepierre

    Strasbourg, 67200

  • Hôpital Bretonneau

    Tours, 37044

  • CH de Troyes

    Troyes, 10003

  • CH Valence

    Valence, 26953

  • CHU Brabois

    Vandœuvre-lès-Nancy, 54511

  • CH de Bretagne Atlantique

    Vannes, 56017

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Belgium16 sites

  • ZNA Stuivenberg

    Antwerp, 2060

  • Clinique sud Luxembourg

    Arlon, 6700

  • RHMS

    Baudour, 7331

  • Az Sint Jan

    Bruges, 8000

  • Hôpital Erasme

    Brussels, 1070

  • Ucl Bruxelles

    Brussels, 1200

  • Grand hôpital de Charleroi

    Charleroi, 6000

  • Hôpital Jolimont

    Haine-Saint-Paul, 7100

  • AZ Groeninge

    Kortrljk, 8500

  • chu Ambroise Paré

    Mons, 7000

  • Clinique St Joseph

    Mons, 7000

  • Clinique ST Pierre

    Ottignies, 1340

  • AZ Delta

    Roeselare, 8800

  • Centre Hospitalier Wallonie Picarde

    Tournai, 7500

  • CH tourelle Peltzer

    Verviers, 4800

  • Chu Mont Godinne

    Yvoir, 5530

Other trials in Belgium

About this study

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

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.

Being tested
BEACOPPesc, BEACOPPesc - ABVD - PET2
Medical subject headings
Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BEACOPPescDrug

  • BEACOPPesc - ABVD - PET2Drug

Study groups in NCT01358747
Study groupRoleWhat they receive
Standard armActive comparatorInduction 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.
Receives: Drug: BEACOPPesc
Experimental armExperimentalInduction 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.
Receives: Drug: BEACOPPesc - ABVD - PET2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2011 (estimated)
  2. Study startMay 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Allocation
Randomised
Intervention model
Parallel groups
IDs, dates and publications
ClinicalTrials.gov ID
NCT01358747
Sponsor's protocol ID
Casasnovas PHRC N 2010
Acronym
AHL 2011
Status last verified
Feb 2026
First submitted
11 May 2011
Last updated
9 Feb 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 30658935

  • 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.

    PubMed 40135712

  • 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.

    PubMed 34990281

  • 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.

    PubMed 34156881

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BEACOPPesc and BEACOPPesc - ABVD - PET2 in people with Hodgkin's Lymphoma, run by Centre Hospitalier Universitaire Dijon at 96 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 96 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01358747, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.

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