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Hodgkin LymphomaPhase 2BREACHNCT02292979

Brentuximab Vedotin Associated With Chemotherapy in Untreated Patients With Hodgkin Lymphoma.

A Phase 2 study testing Doxorubicin, Bleomycin and Vinblastine in people with Hodgkin Lymphoma, run by The Lymphoma Academic Research Organisation at 65 sites in 5 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

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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Hodgkin Lymphoma
What is being tested?
Doxorubicin, Bleomycin and Vinblastine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
65 sitesin 5 countries
Study dates
Mar 2015to 2 Jun 2022
Phase
Phase 2
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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
Show all 26Show fewer
  • 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
  • If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, through 6 months after the last dose of study drug, OR agree to completely abstain from heterosexual intercourse
  • Male patients, even if surgically sterilized (ie, status postvasectomy), who:
  • o Agree to practice effective barrier contraception during the entire study treatment period and through 6 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse.
  • Written informed consent.
  • Required baseline laboratory data:
  • Absolute neutrophil count ≥ 1,500/µL
  • Platelet count ≥ 75,000/ µL
  • Hemoglobin ≥ 8g/dL
  • Serum total bilirubin ≤ 1.5 X ULN unless the elevation is known to be due to Gilbert syndrome.
  • Serum creatinine ≤ 2.0 mg/dL and/or calculated creatinine clearance > 40 mL/minute (Cockcroft-Gault formula or MDRD)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 X ULN

Who cannot join

  • 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)
Show all 22Show fewer
  • 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.
  • Dementia or altered mental status
  • Pregnancy or breastfeeding.
  • Previous treatment with any anti-CD30 antibody.
  • Known hypersensitivity to any excipients contained in the BV formulation or known contra-indication to any drug contained in the chemotherapy regimens
  • Treatment with corticosteroids before baseline PET scan
  • Known active viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy or with untreated known active Grade 3 viral, bacterial, or fungal infection, within 2 weeks prior to the first dose of BV
  • Treatment with any investigational drug within 30 days before first cycle of treatment

Trial locations and contacts

65 sites in 5 countries.

65 sites in 5 countries

France43 sites

  • CHU d'Amiens

    Amiens

  • CHU d'Angers

    Angers

  • CH de Annecy

    Annecy

  • CHU Jean Minjoz

    Besançon

  • CH de Bourg en Bresse

    Bourg-en-Bresse

  • Centre François Baclesse

    Caen

  • CHU de Caen

    Caen

  • CH de Chalon sur Saône

    Chalon-sur-Saône

  • CH de Chambéry

    Chambéry

  • Hôpital Antoine Béclère

    Clamart

  • CHU de Clermont-Ferrand

    Clermont-Ferrand

  • CH Sud Francilien de Corbeil

    Corbeil-Essonnes

  • CHU Henri Mondor

    Créteil

  • CHU de Dijon

    Dijon

  • CHU de Grenoble

    Grenoble

  • CH La Rochelle

    La Rochelle

  • Centre Hospitalier de Versailles - André Mignot

    Le Chesnay, 78157

  • CHRU de Lille - Hôpital Claude Hurriez

    Lille, 59037

  • CHU de Limoges

    Limoges

  • Centre Léon Bérard

    Lyon

  • Institut Paoli Calmettes

    Marseille

  • CH de Meaux

    Meaux

  • CHR de Metz

    Metz

  • CHU de Montpellier - Saint Eloi

    Montpellier

  • CHU de Mulhouse

    Mulhouse

  • CHU Nancy Brabois

    Nancy

  • CHU Hôtel Dieu Nantes

    Nantes

  • CHU de Nîmes

    Nîmes

  • Hôpital Necker

    Paris, 75743

  • Hôpital de la Pitié Salpétrière

    Paris

  • Hôpital Saint Antoine

    Paris

  • Hôpital Saint Louis

    Paris

  • Centre François Magendie

    Pessac

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • CHU Robert Debré

    Reims

  • CHU Pontchaillou

    Rennes

  • CH de Roubaix

    Roubaix

  • Centre Henri Becquerel

    Rouen

  • Institut de Cancérologie de Loire

    Saint-Priest-en-Jarez

  • CHU de Strasbourg

    Strasbourg

  • CHU de Toulouse

    Toulouse

  • CHU Bretonneau

    Tours, 37044

  • Institut Gustave Roussy

    Villejuif

Other trials in France

Belgium11 sites

  • ZNA Middelheim

    Antwerp

  • ZNA Stuivenberg

    Antwerp

  • A.Z. Sint Jan AV

    Bruges

  • Institut Jules Bordet

    Brussels

  • UCL Louvain Saint Luc

    Brussels

  • Grand Hôpital de Charleroi

    Charleroi

  • Universitair Ziekenhuis Antwerpen

    Edegem

  • U.Z. Leuven - Campus Gasthuisberg

    Leuven

  • CHU de Liege

    Liège

  • AZ Delta - Campus H. Hartziekenhuis

    Roeselare

  • CHU Dinant Godinne

    Yvoir

Other trials in Belgium

Netherlands9 sites

  • Academisch Medisch Centrum - Universiteit van Amsterdam

    Amsterdam

  • Antoni Van Leeuwenhoekziekenhuis

    Amsterdam

  • Amphia Ziekenhuis

    Breda

  • Reinier De Graaf Gasthuis

    Delft

  • University Medical Center Groningen

    Groningen

  • Leiden University Medical Centre

    Leiden

  • Radboud University Medical Center Nijmegen

    Nijmegen

  • Erasmus MC Cancer Institute - location Daniel den Hoed

    Rotterdam

  • Erasmus MC

    Rotterdam

Other trials in Netherlands

Croatia1 site

  • University Hospital Rebro

    Zagreb

Other trials in Croatia

Denmark1 site

  • Rigshospitalet

    Copenhagen

Other trials in Denmark

About this study

Official title: Brentuximab Vedotin Associated With Chemotherapy in Untreated Patients With Stage I/II Unfavourable Hodgkin Lymphoma. A Randomized Phase II LYSA-FIL-EORTC Intergroup Study

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.

Read the detailed description

Patients will receive either ABVD chemotherapy (standard treatment = doxorubicin, bleomycin, vinblastine, dacarbazine) or the Brentuximab vedotin in combination with chemotherapy AVD (study treatment), depending on randomization. Radiotherapy is planned after chemotherapy or immunochemotherapy.

PET scans will be performed before inclusion, after 2 cycles of chemotherapy and after 4 cycles of chemotherapy (if PET after two cycles was positive), at the end of treatment and during follow-up period.

Being tested
Doxorubicin, Bleomycin, Vinblastine, Dacarbazine, Brentuximab Vedotin
Keywords
HL
Medical subject headings
Hodgkin Disease

What participants receive

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

  • DoxorubicinDrug

    25mg/m2

  • BleomycinDrug

    10mg/m2

  • VinblastineDrug

    6mg/m2

  • DacarbazineDrug

    375mg/m2

  • Brentuximab VedotinDrug

    1.2 mg/kg

Study groups in NCT02292979
Study groupRoleWhat they receive
ABVDActive comparatorPatients in standard arm receive Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine on Day 1 and D14 of each 4-week-cycle during 4 cycles
Receives: Drug: Doxorubicin; Drug: Bleomycin; Drug: Vinblastine; Drug: Dacarbazine
AVD+BVExperimentalPatients in experimental arm receive Doxorubicin, Vinblastine, Dacarbazine and Brentuximab vedotin on Day 1 and D14 of each 4-week-cycle during 4 cycles
Receives: Drug: Doxorubicin; Drug: Vinblastine; Drug: Dacarbazine; Drug: Brentuximab Vedotin

What is being measured

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

  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.

    Measured: 8 weeks

Secondary outcomes (3)

  1. Complete response (CR) rate

    according to Cheson 2007 criteria

    Measured: 16 weeks

  2. Progression free survival (PFS)

    Survival without disease progression

    Measured: 5 years

  3. Overall survival (OS)

    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 posted18 Nov 2014 (estimated)
  2. Study startMar 2015
  3. Primary completionDec 2016
  4. Study completion2 Jun 2022

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02292979
Sponsor's protocol ID
BREACH
Acronym
BREACH
Status last verified
Aug 2022
First submitted
28 Oct 2014
Last updated
19 Aug 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 39620432

  • Fornecker 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.

    PubMed 35867960

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Doxorubicin, Bleomycin and Vinblastine in people with Hodgkin Lymphoma, run by The Lymphoma Academic Research Organisation at 65 sites in 5 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 26 inclusion and 22 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 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in France, Belgium, Netherlands, Croatia, Denmark. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

PET2 assessment (time frame: 8 weeks). 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 NCT02292979, which also lists 2 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 19 Aug 2022.

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