Brentuximab Vedotin Associated With Chemotherapy in Untreated Patients With Hodgkin Lymphoma.
BREACH
1 other identifier
interventional
170
5 countries
65
Brief Summary
This study aims to evaluate the efficacy of brentuximab vedotin + AVD combination (doxorubicine, vinblastine, dacarbazine) in patients with Hodgkin lymphoma stage I / II with an unfavorable diagnosis, assessed by the negativity of PET (positron emission tomography ) after two cycles of chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2015
Longer than P75 for phase_2
65 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2014
CompletedFirst Posted
Study publicly available on registry
November 18, 2014
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 2, 2022
CompletedAugust 19, 2022
August 1, 2022
1.8 years
October 28, 2014
August 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PET2 assessment
Assessment of PET after two cycles according to the five-point scale Deauville criteria (Negative = 1, 2, 3 and Positive = 4, 5), based on central review.
8 weeks
Secondary Outcomes (3)
Complete response (CR) rate
16 weeks
Progression free survival (PFS)
5 years
Overall survival (OS)
5 years
Study Arms (2)
ABVD
ACTIVE COMPARATORPatients in standard arm receive Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine on Day 1 and D14 of each 4-week-cycle during 4 cycles
AVD+BV
EXPERIMENTALPatients in experimental arm receive Doxorubicin, Vinblastine, Dacarbazine and Brentuximab vedotin on Day 1 and D14 of each 4-week-cycle during 4 cycles
Interventions
Eligibility Criteria
You may qualify if:
- Histologically confirmed CD30+ classical Hodgkin lymphoma
- Supradiaphragmatic Ann Arbor clinical stage I or II
- Previously untreated
- PET scan without IV contrast at diagnosis available for central review with at least one hypermetabolic lesion
- Unfavourable (U) characteristics according to the classic EORTC/LYSA clinical prognostic factors, including patients with at least one of the following factors:
- CSII ≥ 4 nodal areas
- age ≥ 50 yrs
- M/T ratio ≥ 0.35
- ESR ≥ 50 (without B-symptoms) or ESR ≥ 30 with B-symptoms
- ECOG performance status 0-2
- Life expectancy \> 6 months
- Age 18 to 60 years
- Availability for periodic blood sampling, study-related assessments, and management of toxicity at the treating institution.
- Female patients who:
- Are postmenopausal for at least 1 year before the screening visit, OR are surgically sterile, OR
- +11 more criteria
You may not qualify if:
- Histological diagnosis different from classical Hodgkin Lymphoma. Nodular lymphocyte predominant subtypes (nodular paragranuloma or Poppema paragranuloma) are excluded.
- Known cerebral or meningeal disease of any etiology, including signs or symptoms of PML
- Any sensory or motor peripheral neuropathy ≥ Grade 2
- Known history of any of the following cardiovascular conditions
- Myocardial infarction within 2 years of randomization
- New York Heart Association (NYHA) Class III or IV heart failure (see Appendix 14)
- Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- Recent evidence (within 30 days before first dose of study drug) of a left-ventricular ejection fraction \<50%
- Unstable diabetes mellitus (to avoid uninterpretable FDG-PET scan).
- Known HIV positive
- HCV positive
- HBV positive. This means:
- HBsAg positive
- HBsAg negative, anti-HBs positive and/or anti-HBc positive and detectable viral DNA (HBsAg negative patients and viral DNA negative and patients seropositive due to a history of hepatitis B vaccine are eligible).
- Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors. Carcinoma in situ of any type not excluded if complete resection.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (65)
ZNA Middelheim
Antwerp, Belgium
ZNA Stuivenberg
Antwerp, Belgium
A.Z. Sint Jan AV
Bruges, Belgium
Institut Jules Bordet
Brussels, Belgium
UCL Louvain Saint Luc
Brussels, Belgium
Grand Hôpital de Charleroi
Charleroi, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, Belgium
U.Z. Leuven - Campus Gasthuisberg
Leuven, Belgium
CHU de Liege
Liège, Belgium
AZ Delta - Campus H. Hartziekenhuis
Roeselare, Belgium
CHU Dinant Godinne
Yvoir, Belgium
University Hospital Rebro
Zagreb, Croatia
Rigshospitalet
Copenhagen, Denmark
CHU d'Amiens
Amiens, France
CHU d'Angers
Angers, France
CH de Annecy
Annecy, France
CHU Jean Minjoz
Besançon, France
CH de Bourg en Bresse
Bourg-en-Bresse, France
Centre François Baclesse
Caen, France
CHU de Caen
Caen, France
CH de Chalon sur Saône
Chalon-sur-Saône, France
CH de Chambéry
Chambéry, France
Hôpital Antoine Béclère
Clamart, France
CHU de Clermont-Ferrand
Clermont-Ferrand, France
CH Sud Francilien de Corbeil
Corbeil-Essonnes, France
CHU Henri Mondor
Créteil, France
CHU de Dijon
Dijon, France
CHU de Grenoble
Grenoble, France
CH La Rochelle
La Rochelle, France
Centre Hospitalier de Versailles - André Mignot
Le Chesnay, 78157, France
CHRU de Lille - Hôpital Claude Hurriez
Lille, 59037, France
CHU de Limoges
Limoges, France
Centre Léon Bérard
Lyon, France
Institut Paoli Calmettes
Marseille, France
CH de Meaux
Meaux, France
CHR de Metz
Metz, France
CHU de Montpellier - Saint Eloi
Montpellier, France
CHU de Mulhouse
Mulhouse, France
CHU Nancy Brabois
Nancy, France
CHU Hôtel Dieu Nantes
Nantes, France
CHU de Nîmes
Nîmes, France
Hôpital Necker
Paris, 75743, France
Hôpital de la Pitié Salpétrière
Paris, France
Hôpital Saint Antoine
Paris, France
Hôpital Saint Louis
Paris, France
Centre François Magendie
Pessac, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
CHU Robert Debré
Reims, France
CHU Pontchaillou
Rennes, France
CH de Roubaix
Roubaix, France
Centre Henri Becquerel
Rouen, France
Institut de Cancérologie de Loire
Saint-Priest-en-Jarez, France
CHU de Strasbourg
Strasbourg, France
CHU de Toulouse
Toulouse, France
CHU Bretonneau
Tours, 37044, France
Institut Gustave Roussy
Villejuif, France
Academisch Medisch Centrum - Universiteit van Amsterdam
Amsterdam, Netherlands
Antoni Van Leeuwenhoekziekenhuis
Amsterdam, Netherlands
Amphia Ziekenhuis
Breda, Netherlands
Reinier De Graaf Gasthuis
Delft, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Leiden University Medical Centre
Leiden, Netherlands
Radboud University Medical Center Nijmegen
Nijmegen, Netherlands
Erasmus MC Cancer Institute - location Daniel den Hoed
Rotterdam, Netherlands
Erasmus MC
Rotterdam, Netherlands
Related Publications (2)
Goldkuhle M, Kreuzberger N, von Tresckow B, Eichenauer DA, Specht L, Monsef I, Skoetz N. Chemotherapy alone versus chemotherapy plus radiotherapy for adults with early-stage Hodgkin's lymphoma. Cochrane Database Syst Rev. 2024 Dec 2;12(12):CD007110. doi: 10.1002/14651858.CD007110.pub4.
PMID: 39620432DERIVEDFornecker LM, Lazarovici J, Aurer I, Casasnovas RO, Gac AC, Bonnet C, Bouabdallah K, Feugier P, Specht L, Molina L, Touati M, Borel C, Stamatoullas A, Nicolas-Virelizier E, Pascal L, Lugtenburg P, Di Renzo N, Vander Borght T, Traverse-Glehen A, Dartigues P, Hutchings M, Versari A, Meignan M, Federico M, Andre M; LYSA-FIL-EORTC Intergroup. Brentuximab Vedotin Plus AVD for First-Line Treatment of Early-Stage Unfavorable Hodgkin Lymphoma (BREACH): A Multicenter, Open-Label, Randomized, Phase II Trial. J Clin Oncol. 2023 Jan 10;41(2):327-335. doi: 10.1200/JCO.21.01281. Epub 2022 Jul 22.
PMID: 35867960DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc André, Pr
Lymphoma Study Association
- PRINCIPAL INVESTIGATOR
Luc Fornecker, Dr
Lymphoma Study Association
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2014
First Posted
November 18, 2014
Study Start
March 1, 2015
Primary Completion
December 1, 2016
Study Completion
June 2, 2022
Last Updated
August 19, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share