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A Multi-Center Study of Ibrutinib in Combination With Obinutuzumab Versus Chlorambucil in Combination With Obinutuzumab in Patients With Treatment naïve CLL or SLL

Information source: Pharmacyclics
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Lymphocytic Leukemia; Small-Cell Lymphoma

Intervention: Ibrutinib (Drug); Obinutuzumab (Drug); Chlorambucil (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Pharmacyclics

Overall contact:
Lori Styles, M.D, Phone: 855-427-8846, Email: medinfo@pcyc.com

Summary

An open-label, multi-center randomized, phase 3 study of ibrutinib combined with obinutuzumab versus Chlorambucil in combination with obinutuzumab in subjects with treatment-naïve Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.

Clinical Details

Official title: A Randomized, Multi-center, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib in Combination With Obinutuzumab Versus Chlorambucil in Combination With Obinutuzumab in Subjects With Treatment-naïve Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

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

Primary outcome: The primary endpoint of this study is Progressive Free Survival

Secondary outcome:

Overall Response Rate

Rate of minimal residual disease (MRD)-negative responses

Overall Survival

Hematological Improvement measured by hemoglobin

Patient-Reported outcomes

Number of participants with adverse events as a measure of safety and tolerability within each treatment arm.

Detailed description: This is a phase 3, multi-center, randomized, open-label study designed to evaluate the efficacy and safety of ibrutinib in combination with obinutuzumab compared to chlorambucil in combination with obinutuzumab in subjects with treatment-naïve chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Diagnosis of CLL/SLL that meets IWCLL diagnostic criteria 2. Age 65 yrs and older OR if less than 65 years old, must have at least one of the following criteria: 3. Active Disease meeting certain IWCLL criteria 4. Measurable nodal disease by computed tomography (CT) 5. Adequate hematologic function independent of transfusion and growth factor support for at least 7 days prior to screening and randomization within protocol defined limits. 6. Adequate hepatic and renal function 7. Men and women ≥18 years of age. 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. Exclusion Criteria: 1. Any prior treatment of CLL or SLL 2. Evidence of central nervous system (CNS) involvement with primary disease of CLL/SLL 3. History of other malignancies, except:

- Malignancy treated with curative intent and with no known active disease present

for ≥3 years before the first dose of study drug and felt to be at low risk for recurrence by treating physician.

- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence

of disease. Adequately treated carcinoma in situ without evidence of disease. 4. Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura 5. Known or suspected history of Richter's transformation 6. Concurrent administration of >20 mg/day of prednisone within 7 days of randomization unless indicated for prophylaxis or management of allergic reactions (eg, contrast) 7. Known hypersensitivity to one or more study drugs 8. Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug. 9. Any uncontrolled active systemic infection or an infection requiring systemic treatment that was completed ≤7 days before randomization. 10. Known bleeding disorders or hemophilia. 11. History of stroke or intracranial hemorrhage within 6 months prior to enrollment. 12. Known history of human immunodeficiency virus (HIV) or active with hepatitis B virus (HBV) or hepatitis C virus (HCV). 13. Major surgery within 4 weeks of randomization. 14. Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk. 15. Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization. 16. Unable to swallow capsules or malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction. 17. Concomitant use of warfarin or other Vitamin K antagonists. 18. Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor. 19. Lactating or pregnant. 20. Unwilling or unable to participate in all required study evaluations and procedures. 21. Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations)

Locations and Contacts

Lori Styles, M.D, Phone: 855-427-8846, Email: medinfo@pcyc.com

AKH Linz, Linz, Austria; Recruiting
Michael Fridrik, M.D, Principal Investigator

LKH - Universitätsklinikum der PMU Salzburg, Salzburg, Austria; Recruiting
Richard Greil, M.D, Principal Investigator

ZNA Stuivenberg, Antwerpen, Belgium; Recruiting
Ka Lung Wu, M.D, Principal Investigator

Institut Jules Bordet, Bruxelles, Belgium; Recruiting
Dominique Bron, M.D, Principal Investigator

Grand Hôpital de Charleroi, Charleroi, Belgium; Recruiting
Julien Depaus, MD, Principal Investigator

UZ Leuven, Leuven, Belgium; Recruiting
Ann Janssens, M.D, Principal Investigator

AZ Turnhout - Campus Sint-Elisabeth, Turnhout, Belgium; Recruiting
Inge Vrelust, M.D, Principal Investigator

Fakultni nemocnice Hradec Kralove, Hradec Kralove, Czech Republic; Recruiting
Lukas Smolej, M.D, Principal Investigator

Fakultni nemocnice Kralovske Vinohrady, Praha 10, Czech Republic; Recruiting
Jan Novak, M.D, Principal Investigator

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi, Bologna, Italy; Recruiting
Pier Luigi Zinzani, M.D, Principal Investigator

Azienda Ospedaliera Universitaria Careggi, Firenze, Italy; Recruiting
Alberto Bosi, M.D, Principal Investigator

Azienda Ospedaliera Ospedale Niguarda Ca' Granda, Milano, Italy; Recruiting
Alessandra Tedeschi, M.D, Principal Investigator

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy; Recruiting
Agostino Cortellezi, M.D, Principal Investigator

Ospedale San Raffaele, Milano, Italy; Recruiting
Paolo Ghia, M.D, Principal Investigator

A.O.U. Policlinico di Modena, Modena, Italy; Recruiting
Roberto Marasca, M.D, Principal Investigator

Università del Piemonte Orientale Amedeo Avogadro, Novara, Italy; Recruiting
Gianluca Gaidano, M.D, Principal Investigator

Policlinico Universitario Agostino Gemelli, Roma, Italy; Recruiting
Luca Laurenti, M.D, Principal Investigator

A.O.U. Senese Policlinico Santa Maria alle Scotte, Siena, Italy; Recruiting
Monica Bocchia, M.D, Principal Investigator

North Shore Hospital, Auckland, New Zealand; Recruiting
David Simpson, M.D, Principal Investigator

Waikato Hospital, Hamilton, New Zealand; Recruiting
Shahdul Islam, M.D, Principal Investigator

Hospital Clinic i Provincial de Barcelona, Barcelona, Spain; Recruiting
Julio Delgado, M.D, Principal Investigator

Hospital de la Santa Creu i Sant Pau, Barcelona, Spain; Recruiting
Carolina Moreno Atanasio, M.D, Principal Investigator

Hospital Universitari Vall d'Hebron, Barcelona, Spain; Recruiting
Francesc Bosch Albareda, M.D, Principal Investigator

Hospital Universitario 12 de Octubre, Madrid, Spain; Recruiting
Javier de la Serna Torroba, M.D, Principal Investigator

START Madrid. Centro Integral Oncologico Clara Campal, Madrid, Spain; Recruiting
Jaime Perez de Oteyza, M.D, Principal Investigator

Södra Älvsborgs Sjukhus, Borås, Borås, Sweden; Recruiting
Per-ola Andersson, M.D, Principal Investigator

Sunderby sjukhus, Luleå, Sweden; Recruiting
Birgitta Lauri, M.D, Principal Investigator

Skånes Universitetssjukhus, Lund, Lund, Sweden; Recruiting
Karin Karlsson, M.D, Principal Investigator

Karolinska, Stockholm, Sweden; Recruiting
Anders Osterborg, M.D, Principal Investigator

Ankara University Medical Faculty, Ankara, Turkey; Recruiting
Onder Arslan, M.D, Principal Investigator

Gazi University Medical Faculty, Ankara, Turkey; Recruiting
Munci Yagci, M.D, Principal Investigator

Pamukkale Uni. Med. Fac., Denizli, Turkey; Recruiting
Hakan Ismail Sari, M.D, Principal Investigator

Dokuz Eylul University Medicine Faculty, Izmir, Turkey; Recruiting
Fatih Demirkan, M.D, Principal Investigator

Erciyes University Medical Faculty, Kayseri, Turkey; Recruiting
Leylagul Kaynar, M.D, Principal Investigator

Ondokuz Mayis Univ. Med. Fac., Samsun, Turkey; Recruiting
Duzgun Ozatli, M.D, Principal Investigator

University of Alberta Hospital, Edmonton, Alberta, Canada; Recruiting
Loree Larratt, M.D, Principal Investigator

University of San Diego Medical Center, La Jolla, California, United States; Recruiting
Thomas Kipps, M.D, Principal Investigator

Princess Alexandra Hospital, Harlow, Essex, United Kingdom; Recruiting
Faris Al-Refaie, M.D, Principal Investigator

Florida Cancer Specialists - Broadway, Fort Myers, Florida, United States; Recruiting
Scott Lunin, M.D, Principal Investigator

Florida Cancer Specialists, West Palm Beach, Florida, United States; Recruiting
Robert Jacobson, M.D, Principal Investigator

IRCCS Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo, Foggia, Italy; Recruiting
Nicola Cascavilla, M.D, Principal Investigator

Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Centre François Magendie, Pessac cedex, Gironde, France; Recruiting
Marie-Sarah Dilhuydy, M.D, Principal Investigator

Norton Cancer Institute, Louisville, Kentucky, United States; Recruiting
Don Stevens, M.D, Principal Investigator

CHU Nantes - Hôtel Dieu, Nantes cedex 1, Loire Atlantique, France; Recruiting
Beatrice Mahe, M.D, Principal Investigator

ICO l´Hospitalet - Hospital Duran i Reynals, L'Hospitalet de Llobregat, Madrid, Spain; Recruiting
Eva Gonzalez Barca, M.D, Principal Investigator

Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda, Madrid, Spain; Recruiting
Jose Antonio Garcia Marco, M.D, Principal Investigator

Hôpital de Brabois Adultes, Vandoeuvre les Nancy, Meurthe et Moselle, France; Recruiting
Pierre Feugier, M.D, Principal Investigator

Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States; Recruiting
Edwin Kingsley, M.D, Principal Investigator

Westmead Hospital, Westmead, New South Wales, Australia; Recruiting
David Gottlieb, M.D, Principal Investigator

Southeastern Medical Oncology Center, Goldsboro, North Carolina, United States; Recruiting
James Atkins, M.D, Principal Investigator

Oncology Hematology Care, Inc, Cincinnati, Ohio, United States; Recruiting
James Essell, M.D, Principal Investigator

Centre Hospitalier de la côte Basque, Bayonne, Pyrenees Atlantiques, France; Recruiting
Carla Araujo, M.D, Principal Investigator

Princess Alexandra Hospital, Woolloongabba, Queensland, Australia; Recruiting
Devinder Gill, M.D, Principal Investigator

Centre Hospitalier Lyon Sud, Pierre Bénite, Rhone, France; Recruiting
Anne-Sophie Michallet, M.D, Principal Investigator

Royal Adelaide Hospital, Adelaide, South Australia, Australia; Recruiting
Luen Bik To, M.D, Principal Investigator

Royal Hobart Hospital, Hobart, Tasmania, Australia; Recruiting
Rosemary Harrup, M.D, Principal Investigator

Tennessee Oncology, PLLC, Chattanooga, Tennessee, United States; Recruiting
Bertrand Anz, M.D, Principal Investigator

Tennesse Oncology, Nashville, Tennessee, United States; Recruiting
Ian Flinn, M.D, Principal Investigator

Ballarat Base Hospital, Ballarat, Victoria, Australia; Recruiting
Geoffrey Chong, M.D, Principal Investigator

Box Hill Hospital, Box Hill, Victoria, Australia; Recruiting
Paul Coughlin, M.D, Principal Investigator

St. Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia; Recruiting
Mohammad Bazargan, M.D, Principal Investigator

Austin Hospital, Heidelberg, Victoria, Australia; Recruiting
Paul Turner, M.D, Principal Investigator

St James's Institute of Oncology, Leeds, West Yorkshire, United Kingdom; Recruiting
Peter Hillmen, M.D, Principal Investigator

Additional Information

Starting date: October 2014
Last updated: May 20, 2015

Page last updated: August 23, 2015

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