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

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: Doxorubicin (Drug); Bleomycin (Drug); Vinblastine (Drug); Dacarbazine (Drug); Brentuximab Vedotin (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: The Lymphoma Academic Research Organisation

Official(s) and/or principal investigator(s):
Marc André, Pr, Principal Investigator, Affiliation: Lymphoma Study Association
Luc Fornecker, Dr, Principal Investigator, Affiliation: Lymphoma Study Association

Overall contact:
Julie Assémat, Phone: +33 4 72 66 93 33, Email: julie.assemat@lysarc.org

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: PET2 assessment

Secondary outcome:

Complete response (CR) rate

Progression free survival (PFS)

Overall survival (OS)

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.

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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

- 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

Exclusion Criteria:

- 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.

- 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

Locations and Contacts

Julie Assémat, Phone: +33 4 72 66 93 33, Email: julie.assemat@lysarc.org

ZNA Middelheim, Antwerpen, Belgium; Recruiting
Karolien BEEL, MD, Principal Investigator

ZNA Stuivenberg, Antwerpen, Belgium; Recruiting
Ka Lung WU, MD, Principal Investigator

A.Z. Sint Jan AV, Brugge, Belgium; Recruiting
Achiel VAN HOOF, MD, Principal Investigator

Institut Jules Bordet, Bruxelles, Belgium; Recruiting
Marie MAEREVOET, MD, Principal Investigator

UCL Louvain Saint Luc, Bruxelles, Belgium; Recruiting
Eric VAN DEN NESTE, PR, Principal Investigator

Grand Hôpital de Charleroi, Charleroi, Belgium; Recruiting
Delphine PRANGER, MD, Principal Investigator

Universitair Ziekenhuis Antwerpen, Edegem, Belgium; Recruiting
Wilfried A. SCHROYENS, Professor, Principal Investigator

U.Z. Leuven - Campus Gasthuisberg, Leuven, Belgium; Recruiting
Pascal WAULTER, MD, Principal Investigator

CHU de Liege, Liege, Belgium; Recruiting
Christophe BONNET, MD, Principal Investigator

AZ Delta - Campus H. Hartziekenhuis, Roeselare, Belgium; Recruiting
Dries DEEREN, MD, Principal Investigator

CHU Dinant Godinne, Yvoir, Belgium; Recruiting
Marc ANDRE, Professor, Principal Investigator

University Hospital Rebro, Zagreb, Croatia; Not yet recruiting
Igor AURER, Professor, Principal Investigator

Rigshospitalet, Copenhagen, Denmark; Not yet recruiting
Lena SPECHT, MD, Principal Investigator

CHU d'Amiens, Amiens, France; Recruiting
Jean-Pierre MAROLLEAU, Professor, Principal Investigator

CHU d'Angers, Angers, France; Recruiting
Marie-Pierre MOLES-MOREAU, MD, Principal Investigator

CH de Annecy, Annecy, France; Recruiting
Nicolas DAGUINDAU, MD, Principal Investigator

CHU Jean Minjoz, Besançon, France; Recruiting
Marian HECZKO, MD, Principal Investigator

CH de Bourg en Bresse, Bourg en Bresse, France; Recruiting
Hubert ORFEUVRE, MD, Principal Investigator

Centre François Baclesse, Caen, France; Recruiting
Xavier LEVALTIER, MD, Principal Investigator

CHU de Caen, Caen, France; Recruiting
Oumedaly REMAN, MD, Principal Investigator

CH de Chalon sur Saône, Chalon sur Saône, France; Recruiting
Laurent VOILLAT, MD, Principal Investigator

CH de Chambéry, Chambéry, France; Recruiting
Gian Matteo PICA, MD, Principal Investigator

Hôpital Antoine Béclère, Clamart, France; Recruiting
François BOUE, Professor, Principal Investigator

CHU de Clermont-Ferrand, Clermont-Ferrand, France; Recruiting
Victoria CACHEUX, MD, Principal Investigator

CH Sud Francilien de Corbeil, Corbeil Essonnes, France; Recruiting
Bertrand JOLY, MD, Principal Investigator

CHU Henri Mondor, Créteil, France; Recruiting
Corinne HAIOUN, Professor, Principal Investigator

CHU de Dijon, Dijon, France; Recruiting
Olivier CASASNOVAS, Professor, Principal Investigator

CHU de Grenoble, Grenoble, France; Recruiting
Lysiane MOLINA, MD, Principal Investigator

CH La Rochelle, La Rochelle, France; Recruiting
Emmanuel FLECK, MD, Principal Investigator

Centre Hospitalier de Versailles - André Mignot, Le Chesnay 78157, France; Recruiting
Hassan FARHAT, MD, Principal Investigator

CHRU de Lille - Hôpital Claude Hurriez, Lille 59037, France; Recruiting
Franck MORSCHHAUSER, MD, Principal Investigator

CHU de Limoges, Limoges, France; Recruiting
Mohammed TOUATI, MD, Principal Investigator

Centre Léon Bérard, Lyon, France; Recruiting
Emmanuelle NICOLAS-VIRELIZIER, MD, Principal Investigator

Institut Paoli Calmettes, Marseille, France; Recruiting
Reda BOUABDALLAH, MD, Principal Investigator

CH de Meaux, Meaux, France; Recruiting
Wajed ABARAH, MD, Principal Investigator

CHR de Metz, Metz, France; Recruiting
Alina ZAMFIR, MD, Principal Investigator

CHU de Montpellier - Saint Eloi, Montpellier, France; Recruiting
Philippe QUITTET, MD, Principal Investigator

CHU de Mulhouse, Mulhouse, France; Recruiting
Jean-Claude EISENMANN, MD, Principal Investigator

CHU Nancy Brabois, Nancy, France; Recruiting
Serge BOLOGNA, MD, Principal Investigator

CHU Hôtel Dieu Nantes, Nantes, France; Recruiting
Thomas GASTINNE, MD, Principal Investigator

CHU de Nîmes, Nîmes, France; Recruiting
Agathe WAULTIER-RASCALOU, MD, Principal Investigator

Hôpital de la Pitié Salpétrière, Paris, France; Recruiting
Jean GABARRE, MD, Principal Investigator

Hôpital Necker, Paris 75743, France; Recruiting
Richard DELARUE, MD, Principal Investigator

Hôpital Saint Antoine, Paris, France; Recruiting
Zora MARJANOVIC, MD, Principal Investigator

Hôpital Saint Louis, Paris, France; Recruiting
Pauline BRICE, MD, Principal Investigator

Centre François Magendie, Pessac, France; Recruiting
Krimo BOUABDALLAH, MD, Principal Investigator

Centre Hospitalier Lyon Sud, Pierre Bénite 69495, France; Recruiting
Gilles SALLES, Professor, Principal Investigator

CHU Robert Debré, Reims, France; Recruiting
Alain DELMER, Professor, Principal Investigator

CHU Pontchaillou, Rennes, France; Recruiting
Thierry LAMY DE LA CHAPELLE, Professor, Principal Investigator

CH de Roubaix, Roubaix, France; Recruiting
Laurence DETOURMIGNIES, MD, Principal Investigator

Centre Henri Becquerel, Rouen, France; Recruiting
Aspasia STAMATOULLAS, Doctor, Principal Investigator

Institut de Cancérologie de Loire, Saint Priest en Jarez, France; Recruiting
Jérome CORNILLON, MD, Principal Investigator

CHU de Strasbourg, Strasbourg, France; Recruiting
Luc-Matthieu FORNECKER, MD, Principal Investigator

CHU de Toulouse, Toulouse, France; Recruiting
Cécile BOREL, MD, Principal Investigator

CHU Bretonneau, Tours 37044, France; Recruiting
Marian ERTAULT, MD, Principal Investigator

Institut Gustave Roussy, Villejuif, France; Recruiting
Vincent RIBRAG, MD, Principal Investigator

Academisch Medisch Centrum - Universiteit van Amsterdam, Amsterdam, Netherlands; Not yet recruiting
Marie Jose KERSTEN, MD, Principal Investigator

Antoni Van Leeuwenhoekziekenhuis, Amsterdam, Netherlands; Not yet recruiting
Johanna W. BAARS, MD, Principal Investigator

Amphia Ziekenhuis, Breda, Netherlands; Not yet recruiting
Rinske BOERSMA, MD, Principal Investigator

Reinier De Graaf Gasthuis, Delft, Netherlands; Not yet recruiting
E. F. M. POSTHUMA, MD, Principal Investigator

University Medical Center Groningen, Groningen, Netherlands; Not yet recruiting
G. W. VAN IMHOFF, MD, Principal Investigator

Leiden University Medical Centre, Leiden, Netherlands; Not yet recruiting
Erik MARIJT, MD, Principal Investigator

Radboud University Medical Center Nijmegen, Nijmegen, Netherlands; Not yet recruiting
John RAEMAEKERS, MD, Principal Investigator

Erasmus MC, Rotterdam, Netherlands; Not yet recruiting
P. J. LUGTENBURG, MD, Principal Investigator

Erasmus MC Cancer Institute - location Daniel den Hoed, Rotterdam, Netherlands; Not yet recruiting
Jeanette DOORDUIJN, MD, Principal Investigator

Additional Information

Starting date: March 2015
Last updated: March 31, 2015

Page last updated: August 23, 2015

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