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Brentuximab Vedotin as Consolidation Treatment in Patients With Stage I/II HL and PET Positivity After 2 Cycles of ABVD

Information source: The Lymphoma Academic Research Organisation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hodgkin Lymphoma

Intervention: brentuximab vedotin (Drug); Cyclophosphamide (Drug); Adriamycin (Drug); Oncovin (Drug); Bleomycin (Drug); Etoposide (Drug); Procarbazine (Drug); Prednisone (Drug); G-CSF (Drug); 30 Grays (Radiation)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: The Lymphoma Academic Research Organisation

Official(s) and/or principal investigator(s):
Pauline BRICE, MD, Principal Investigator, Affiliation: Lymphoma Study Association
Thomas GASTINNE, MD, Principal Investigator, Affiliation: Lymphoma Study Association

Overall contact:
Stéphanie DOYEN, Phone: +33 4 72 66 93 33, Email: stephanie.doyen@lysarc.org


This study aims to evaluate the efficacy brentuximab vedotin as consolidation treatment in

patients with stage I/II Hodgkin's lymphoma and 18-fluorodeoxyglucose (FDG) - PET positivity

after 2 cycles of ABVD (adriamycin, bleomycin, vinblastine, and dacarbazine).

Clinical Details

Official title: Brentuximab Vedotin as Consolidation Treatment in Patients With Stage I/II Hodgkin's Lymphoma and FDG-PET Positivity After 2 Cycles of ABVD

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Progression free survival (PFS)

Secondary outcome:

Complete Response rate (CR rate)

Overall survival

Detailed description: This study aims to evaluate the progression free survival after treatment for patient with stage I/II supradiaphragmatic HL patient and PET positive after 2 courses of ABVD. The treatment consist of 3 phases :

- induction treatment with 2 cycles every 3 weeks of bleomycin, etoposide, Adriamycin,

cyclophosphamide, oncovin, procarbazine, and prednisone (BEACOPP) escalated

- radiotherapy 30 Gy starting 3 to 4 weeks after last day of second course of


- consolidation treatment with 8 cycles every 21 days of brentuximab vedotin


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


Inclusion Criteria: 1. Patients must have histologically confirmed cluster of differentiation antigen 30+ (CD30+) classical Hodgkin lymphoma 2. Patients must have provided voluntary written informed consent 3. Supradiaphragmatic Ann Arbor clinical stage I or II 4. Mandatory PET scan performed at diagnosis 5. Patients treated with first-line ABVD and PET scan positive after 2 cycles (Deauville score 4 & 5) 6. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 7. Life expectancy > 6 months 8. Patients must be 18-65 years of age 9. Patients must be available for periodic blood sampling, study-related assessments and management of toxicity at the treating institution 10. 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 11. Male patients, even if surgically sterilized, who 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 12. Clinical laboratory values as specified below before the first dose of study drug:

- Absolute neutrophil count ≥ 1,500/µL

- Platelet count ≥ 75,000/ µL

- Total bilirubin must be < 1. 5 x the upper limit of the normal (ULN) unless the

elevation is known to be due to Gilbert syndrome

- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)must be < 3 x

the upper limit of the normal range

- Serum creatinine must be < 2. 0 mg/dL and/or creatinine clearance or calculated

creatinine clearance > 40 mL/minute

- Hemoglobin must be ≥ 8g/dL

13. Patient affiliated to social security system Exclusion Criteria: 1. Patients with dementia or altered mental status that would preclude compliance with drug delivery 2. Women who are pregnant or breastfeeding 3. Patients with symptomatic pulmonary disease 4. Patients with known history of any of the following cardiovascular conditions:

- Myocardial infarction within 2 years of inclusion

- New York Heart Association (NYHA) Class III or IV heart failure

- 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 6 months before first dose of study drug) of a

left-ventricular ejection fraction <50% 5. Any history of cancer or cancer treatment during the last 3 years with the exception of non-melanoma skin cancer or stage 0 (in situ) carcinoma of any type if they have undergone complete resection 6. Uncontrolled infectious disease, including active Hepatitis B Virus (HBV) infection defined by either detection of Hepatitis B surface (HBs) Antigen or presence of Hepatitis B core (HBc) antibody without detectable anti HBs antibody 7. Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics at the time of inclusion and planned to be still on going within 2 weeks prior to first study drug dose 8. Known Human Immunodeficiency Virus (HIV), known or suspected hepatitis C Virus (HCV) or human T-cell lymphotrophic virus (HTLV) serology positivity 9. Patients who have been treated previously with any anti-CD30 antibody 10. Known hypersensitivity to any excipients contained in the brentuximab vedotin formulation 11. Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of Progressive Multifocal Leukoencephalopathy (PML) 12. Any sensory or motor peripheral neuropathy greater than or equal to Grade 2 13. Patients that have not completed any prior treatment chemotherapy and/or other investigational agents within at least 5 half-lives of last dose of that prior treatment

Locations and Contacts

Stéphanie DOYEN, Phone: +33 4 72 66 93 33, Email: stephanie.doyen@lysarc.org

CH Victor Dupouy, Argenteuil 95100, France; Not yet recruiting
Driss CHAOUI, MD, Email: driss.chaoui@ch-argenteuil.fr
Driss CHAOUI, MD, Principal Investigator

Polyclinique Bordeaux Nord, Bordeaux 33300, France; Not yet recruiting
Olivier FITOUSSI, MD, Email: o.fitoussi@bordeauxnord.com
FITOUSSI, MD, Principal Investigator

Centre François Baclesse, Caen 14076, France; Not yet recruiting
Christophe FRUCHART, MD, Email: c.fruchart@baclesse.unicancer.fr
Christophe FRUCHART, MD, Principal Investigator

CH de Chambéry, Chambéry 73011, France

CH Sud Francilien, Corbeil Essones 91108, France; Not yet recruiting
Bertrand JOLY, MD, Email: bertrand.joly@ch-sud-francilien.fr
Bertrand JOLY, MD, Principal Investigator

Hôpital Henri Mondor, Creteil 94010, France; Not yet recruiting
Corinne HAIOUN, Prof, Email: corinne.haioun@hmn.aphp.fr
Corinne HAIOUN, Prof, Principal Investigator

CHU de Dijon - Hôpital le Bocage, Dijon 21034, France; Not yet recruiting
Olivier CASASNOVAS, MD, Email: olivier.casasnovas@chu-dijon.fr
Olivier CASASNOVAS, MD, Principal Investigator

Hôpital André Mignot, Le Chesnay 78157, France; Not yet recruiting
Hassan FARHAT, MD, Email: hfarhat@ch-versailles.fr
Hassan FARHAT, MD, Principal Investigator

Clinique Victor Hugo, Le Mans 72000, France; Not yet recruiting
Katell LE DÛ, MD, Email: k.ledu@cjb72.org
Katell LE DÛ, MD, Principal Investigator

CHRU Lille - Hôpital Claude Huriez, Lille 59037, France; Not yet recruiting
Franck MORSCHHAUSER, Prof, Email: franck.morschhauser@chru-lille.fr
Franck MORSCHHAUSER, Prof, Principal Investigator

CHU de Limoges, Limoges 87042, France; Not yet recruiting
Mohamed TOUATI, MD, Email: mohamed.touati@chu-limoges.fr
Mohamed TOUATI, MD, Principal Investigator

Centre Léon Bérard, Lyon 69008, France; Not yet recruiting
Emmanuelle NICOLAS- VIRELIZIER, MD, Email: emmanuelle.nicolas@lyon.unicancer.fr
Emmanuelle NICOLAS- VIRELIZIER, MD, Principal Investigator

Hôpital de la Conception, Marseille 13385, France; Not yet recruiting
Régis COSTELLO, Prof, Email: regis.costello@free.fr
Régis COSTELLO, Prof, Principal Investigator

Institut Paoli Calmette, Marseille 13273, France; Not yet recruiting
Réda BOUABDALLAH, MD, Email: bouabdallahr@ipc.unicancer.fr
Réda BOUABDALLAH, MD, Principal Investigator

CHU Montpellier - Saint ELOI, Montpellier 34295, France

CHU de Nantes, Nantes 44093, France; Not yet recruiting
Thomas GASTINNE, MD, Email: thomas.gastinne@chu-nantes.fr
Thomas GASTINNE, MD, Principal Investigator

Hôpital Saint Louis, Paris cedex 10 75475, France; Not yet recruiting
Pauline BRICE, MD, Email: pauline.brice@sls.aphp.fr
Pauline BRICE, MD, Principal Investigator

Hôpital Cochin, Paris 75004, France; Not yet recruiting
Bénédicte DEAU-FISCHER, MD, Email: benedicte.deau-fischer@cch.aphp.fr
Bénédicte DEAU-FISCHER, MD, Principal Investigator

Hôpital de la Pitié Salpétrière, Paris 75651, France; Not yet recruiting
Jean GABARRE, MD, Email: jean.gabarre@psl.aphp.fr
Jean GABARRE, MD, Principal Investigator

CH Perpignan, Perpignan 66046, France; Not yet recruiting
Laurence SANHES, MD, Email: laurence.sanhes@ch-perpignan.fr
Laurence SANHES, MD, Principal Investigator

Hôpital Haut Lévêque, Pessac 33604, France; Not yet recruiting
Krimo BOUABDALLAH, MD, Email: krimo.bouabdallah@chu-bordeaux.fr
Krimo BOUABDALLAH, MD, Principal Investigator

CHU Lyon Sud, Pierre Bénite Cedex 69495, France; Not yet recruiting
Gilles SALLES, Prof, Email: gilles.salles@chu-lyon.fr
Gilles SALLES, Prof, Principal Investigator

CHU Robert Debre, Reims 51092, France; Not yet recruiting
Alain DELMER, MD, Email: adelmer@chu-reims.fr
Alain DELMER, MD, Principal Investigator

CHU Pontchaillou, Rennes 35033, France; Not yet recruiting
Thierry LAMY de la CHAPELLE, Prof, Email: thierry.lamy.de.la.chapelle@chu-rennes.fr
Thierry LAMY de la CHAPELLE, Prof, Principal Investigator

Centre Henri Becquerel, Rouen 76000, France; Not yet recruiting
Aspasia STAMATOULLAS, MD, Email: aspasia.stamatoullas@chb.unicancer.fr
Aspasia STAMATOULLAS, MD, Principal Investigator

CHU de Strasbourg, Strasbourg 67098, France; Not yet recruiting
Luc-Matthieu FORNECKER, MD, Email: luc-matthieu.fornecker@chru-strasbourg.fr
Luc-Matthieu FORNECKER, MD, Principal Investigator

I.U.C.T Oncopole, Toulouse 31059, France; Not yet recruiting
Cécile BOREL, MD, Email: borel.c@chu-toulouse.fr
Cécile BOREL, MD, Principal Investigator

CHU Bretonneau, Tours 37044, France

CHU de Brabois, Vandoeuvre Cedex 54511, France; Not yet recruiting
Serge BOLOGNA, MD, Email: s.bologna@chu-nancy.fr
Serge BOLOGNA, MD, Principal Investigator

Gustave Roussy Cancer Campus, Villejuif 94805, France; Not yet recruiting
Vincent RIBRAG, MD, Email: vincent.ribrag@gustaveroussy.fr
Vincent RIBRAG, MD, Principal Investigator

Additional Information

Starting date: December 2014
Last updated: November 27, 2014

Page last updated: August 23, 2015

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