Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

Summary

The purpose of this open-label, multicenter, randomized, Phase III study is to evaluate the benefit of venetoclax in combination with rituximab compared with bendamustine in combination with rituximab in participants with relapsed or refractory CLL. Participants will be randomly assigned in 1:1 ratio to receive either venetoclax + rituximab (Arm A) or bendamustine + rituximab (Arm B).

Official Title

A Multicenter, Phase III, Open-Label, Randomized Study in Relapsed/Refractory Patients With Chronic Lymphocytic Leukemia to Evaluate the Benefit of Venetoclax (GDC-0199/ABT-199) Plus Rituximab Compared With Bendamustine Plus Rituximab

Keywords

Chronic Lymphocytic Leukemia Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Venetoclax Rituximab Bendamustine Hydrochloride Bendamustine

Eligibility

You can join if…

Open to people ages 18 years and up

  • Diagnosis of CLL per diagnostic criteria for relapsed or refractory CLL per the international workshop on chronic lymphocytic leukemia (iwCLL) guidelines
  • Previously treated with 1-3 lines of therapy (example: completed greater than or equal to [>/=] 2 treatment cycles per therapy), including at least one standard chemotherapy-containing regimen
  • Participants previously treated with bendamustine only if their duration of response was >/= 24 months
  • Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to(</=) 1
  • Adequate bone marrow function
  • Adequate renal and hepatic function
  • Participants must use effective birth control throughout study until at least 30 days after study treatment or 1 year after rituximab treatment, whichever is later; female participants must not be pregnant or breast-feeding
  • For participants with the 17p deletion, previously treated with 1-3 lines of therapy,including at least one prior standard chemotherapy-containing regimen or at least one prior alemtuzumab-containing therapy

You CAN'T join if...

  • Transformation of CLL to aggressive non-Hodgkin lymphoma or central nervous system(CNS) involvement by CLL
  • Undergone an allogenic stem cell transplant
  • A history of significant renal, neurologic, psychiatric, endocrine, metabolic,immunologic, cardiovascular or hepatic disease
  • Hepatitis B or C or known human immunodeficiency virus (HIV) positive
  • Receiving warfarin treatment
  • Received an anti-CLL monoclonal antibody within 8 weeks prior to the first dose of study drug
  • Received any anti-cancer or investigational therapy within 28 days prior to the first dose of study drug or has not recovered to less than Grade 2 clinically significant adverse effect(s)/toxicity(ies) of any previous therapy
  • Received cytochrome P450 3A4 (CYP3A4) inhibitors (such as fluconazole, ketoconazole and clarithromycin) or inducers (such as rifampin, carbamazapine, phenytoin, St.John's Wort) within 7 days prior to the first dose of venetoclax
  • History of prior venetoclax treatment
  • Participants with another cancer, history of another cancer considered uncured on in complete remission for <5 years, or currently under treatment for another suspected cancer except non-melanoma skin cancer or carcinoma in situ of the cervix that has been treated or excised and is considered resolved
  • Malabsorption syndrome or other condition that precludes enteral route of administration
  • Other clinically significant uncontrolled condition(s) including, but not limited to,systemic infection (viral, bacterial or fungal)
  • Vaccination with a live vaccine within 28 days prior to randomization
  • Consumed grapefruit or grapefruit products, seville oranges (including marmalade containing seville oranges), or star fruit within 3 days prior to the first dose of study treatment
  • A cardiovascular disability status of New York Heart Association Class >/=3. Class 3 is defined as cardiac disease in which participants are comfortable at rest but have marked limitation of physical activity due to fatigue, palpitations, dyspnea, or anginal pain
  • Major surgery within 30 days prior to the first dose of study treatment
  • A participant who is pregnant or breastfeeding
  • Known allergy to both xanthine oxidase inhibitors and rasburicase

Locations

  • University of California San Diego Medical Center
    La Jolla, California, 92093-5354, United States
  • Huntsman Cancer Institute; University of Utah
    Salt Lake City, Utah, 84112, United States
  • Baylor University Medical Center; Research Institute
    Dallas, Texas, 75204, United States
  • Baylor University Medical Center
    Dallas, Texas, 75204, United States
  • Foothills Medical Centre; Centre Dept of Medical Clinical Neuroscience
    Calgary, Alberta, T2N 2T9, Canada
  • Saskatoon City Hospital;Saskatchewan Cancer Centre
    Saskatoon, Saskatchewan, S7N 4H4, Canada
  • Ingalls Hospital
    Harvey, Illinois, 60426, United States
  • Henry Ford Health System
    Detroit, Michigan, 48202, United States
  • University Hospitals Case Medical Center
    Cleveland, Ohio, 44106, United States
  • Mayo Clinic in Florida; Neurology
    Jacksonville, Florida, 32224, United States
  • Medical University of South Carolina
    Charleston, South Carolina, 29425, United States
  • Juravinski Cancer Clinic
    Hamilton, Ontario, L8N 3Z5, Canada
  • Princess Margaret Hospital; Department of Med Oncology
    Toronto, Ontario, M5G 2M9, Canada
  • Memorial Sloan Kettering Cancer Center; Clinical Trials Office
    New York, New York, 10021, United States
  • Columbia University Medical Center
    New York, New York, 10032, United States
  • Jewish General Hospital
    Montreal, Quebec, H3T 1E2, Canada
  • Queen Elizabeth Hospital; R&D Department
    Birmingham, B15 2WB, United Kingdom
  • Bristol Haematology and Oncology Centre
    Bristol, BS2 8ED, United Kingdom
  • University Hospital of Wales
    Cardiff, CF14 4XW, United Kingdom
  • James Paget Hospital
    Great Yarmouth, NR31 6LA, United Kingdom
  • St James Institute of Oncology
    Leeds, LS9 7TF, United Kingdom
  • Leicester Royal Infirmary
    Leicester, LE1 5WW, United Kingdom
  • The Christie
    Manchester, M20 4BX, United Kingdom
  • Southampton General Hospital
    Southampton, SO16 6YD, United Kingdom
  • Singleton Hospital; Pharmacy Department
    Swansea, SA2 8QA, United Kingdom
  • Sunderby sjukhus
    Luleå, 97180, Sweden
  • Skånes Universitetssjukhus, Lund
    Lund, 221 85, Sweden
  • Akademiska Sjukhuset
    Uppsala, 75185, Sweden
  • Aalborg Sygehus;Endokrinologisk afd
    Aalborg, 9100, Denmark
  • Herlev Hospital
    Herlev, 2730, Denmark
  • Rigshospitalet
    København, 2100, Denmark
  • Odense Universitetshospital
    Odense C, 5000, Denmark
  • Sjællands Universitetshospital, Roskilde
    Roskilde, 4000, Denmark
  • Sygehus Lillebælt, Vejle
    Vejle, 7100, Denmark
  • Meander Medisch Centrum; Locatie Lichtenberg
    Amersfoort, 3818 ES, Netherlands
  • VU Medisch Centrum
    Amsterdam, 1081 HV, Netherlands
  • Academisch Medisch Centrum; Opthamology
    Amsterdam, 1105 AZ, Netherlands
  • Albert Schweitzer Ziekenhuis, Dordwijk; Internal Medicine, Hemato-Oncology
    Dordrecht, 3318 AT, Netherlands
  • Maxima Medisch Centrum, Eindhoven
    Eindhoven, 5600 PD, Netherlands
  • Medisch Spectrum Twente
    Enschede, 7512 KZ, Netherlands
  • Universitair Medisch Centrum Groningen
    Groningen, 9713 GZ, Netherlands
  • Leids Universitair Medisch Centrum; Cardiology
    Leiden, 2333 ZA, Netherlands
  • Hagaziekenhuis, locatie Leyweg
    Nl -den Haag, 2504 LN, Netherlands
  • Erasmus Medisch Centrum Rotterdam; Lokatie Daniel den Hoed
    Rotterdam, 3075EA, Netherlands
  • Maasstad ziekenhuis
    Rotterdam, 3078 HT, Netherlands
  • Zuyderland Medisch Centrum
    Sittard-Geleen, 6162 BG, Netherlands
  • UMC Utrecht
    Utrecht, 3508 GA, Netherlands
  • ZNA Stuivenberg
    Antwerpen, 2060, Belgium
  • Institut Jules Bordet
    Brussels, 1000, Belgium
  • CHU Brugmann (Victor Horta)
    Bruxelles, 1020, Belgium
  • Cliniques Universitaires St-Luc
    Bruxelles, 1200, Belgium
  • UZ Gent
    Gent, 9000, Belgium
  • AZ Groeninge
    Kortrijk, 8500, Belgium
  • UZ Leuven; Maag, -darm en leverziekten/endoscopie - Endoscopy
    Leuven, 3000, Belgium
  • CHU UCL Mont-Godinne
    Mont-godinne, 5530, Belgium
  • AZ Delta (Campus Wilgenstraat)
    Roeselare, 8800, Belgium
  • SHI Republican Clinical Oncological Dispensary of HM RT
    Kazan, 420029, Russian Federation
  • Kemerovo Regional Clinical Hospital
    Kemerovo, 650066, Russian Federation
  • FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
    Moscow, 115478, Russian Federation
  • BHI of Omsk region Clinical Oncology Dispensary
    Omsk, 644013, Russian Federation
  • SRI of Hematology and Transfusiology
    St. Petersburg, 191024, Russian Federation
  • North-West Federal Medical Research Center n.a. V.A. Almazov
    St. Petersburg, 197341, Russian Federation
  • Hopital Avicenne
    Bobigny, 93000, France
  • Hôpital Morvan
    Brest, 29609, France
  • CHU Clermont Ferrand - Hôpital d'Estaing
    Clermont Ferrand cedex 1, 63003, France
  • Centre Hospitalier Départemental Les Oudairies
    La Roche sur Yon, 85025, France
  • Hopital Claude Huriez - CHU Lille
    Lille, 59037, France
  • Hopital Saint Eloi
    Montpellier, 34295, France
  • CHU Nantes - Hôtel Dieu; Service Assistance Medicale à la Procreation
    Nantes, 44093, France
  • Hopital Robert Debre
    Paris, 75019, France
  • Centre Hospitalier Lyon Sud
    Pierre Benite, 69495, France
  • CHU Poitiers - Hopital La Miletrie
    Poitiers, 86000, France
  • CHU de Rennes - Hopital de Pontchaillo
    Rennes, 35033, France
  • Centre Henri Becquerel
    Rouen, 76038, France
  • Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)
    Toulouse, 31059, France
  • CHU Tours - Hôpital Bretonneau
    Tours, 37044, France
  • Hôpital de Brabois Adultes
    Vandoeuvre-les-nancy, 54511, France
  • Vivantes Klinikum Am Urban; Cardiology
    Berlin, 10967, Germany
  • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
    Berlin, 12200, Germany
  • Charite - Campus Virchow-Klinikum; Cardiology
    Berlin, 13353, Germany
  • Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
    Dresden, 01307, Germany
  • Universitaetsklinikum Freiburg; Innere Medizin II, Gastroenterologie
    Freiburg, 79106, Germany
  • Universitätsklinikum Heidelberg
    Heidelberg, 69120, Germany
  • Universitätsklinikum Koeln
    Koeln, 50937, Germany
  • Kliniken Maria Hilf GmbH
    Moenchengladbach, 41063, Germany
  • Klinikum Harlaching
    Muenchen, 81545, Germany
  • Klinikum Schwabing
    München, 80804, Germany
  • Universitätsklinikum Tübingen
    Tuebingen, 72076, Germany
  • Hospital Universitario Puerta de Hierro Majadahonda
    Majadahonda, Madrid, 28222, Spain
  • Complejo Hospitalario de Navarra
    Pamplona, Navarra, 31008, Spain
  • Hospital Universitari Vall d'Hebron
    Barcelona, 08035, Spain
  • Hospital Clinic i Provincial de Barcelona; Hematology
    Barcelona, 08036, Spain
  • MD Anderson Cancer Center
    Madrid, 28033, Spain
  • Hospital Universitario 12 de Octubre
    Madrid, 28041, Spain
  • Hospital Clinico Universitario de Salamanca
    Salamanca, 37007, Spain
  • Hospital Universitario Virgen del Rocio
    Sevilla, 41013, Spain
  • Inselspital-Universitaetsspital Bern
    Bern, 3010, Switzerland
  • Luzerner Kantonsspital, Hämatologie
    Luzern, 6000, Switzerland
  • Kantonsspital St. Gallen
    St. Gallen, 9007, Switzerland
  • Universitaetsspital Zuerich
    Zürich, 8091, Switzerland
  • Fakultni nemocnice Brno
    Brno, 613 00, Czechia
  • Fakultni nemocnice Hradec Kralove
    Hradec Kralove, 500 05, Czechia
  • Fakultní nemocnice Olomouc
    Olomouc, 775 20, Czechia
  • Fakultni nemocnice Ostrava
    Ostrava - Poruba, 708 52, Czechia
  • Vseobecna fakultni nemocnice v Praze
    Praha 2, 128 08, Czechia
  • Fakultni nemocnice Kralovske Vinohrady
    Praha, 100 34, Czechia
  • SP ZOZ Zespol Szpitali Miejskich w Chorzowie
    Chorzow, 41-500, Poland
  • Uniwersyteckie Centrum Kliniczne
    Gdansk, 80-214, Poland
  • Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
    Lodz, 93-513, Poland
  • Samodzielny Publiczny Szpital Kliniczny nr 1
    Lublin, 20-081, Poland
  • Szpital Wojewodzki w Opolu;Pododdz. Gastroenter., Pododdz. Hematologii
    Opole, 45-372, Poland
  • MTZ Clinical Research Sp. z o.o.
    Warszawa, 02-106, Poland
  • Seoul National University Bundang Hospital
    Gyeonggi-do, 13620, Korea, Republic of
  • Korea University Anam Hospital
    Seoul, 02841, Korea, Republic of
  • Severance Hospital, Yonsei University Health System
    Seoul, 03722, Korea, Republic of
  • Konkuk University Medical Center
    Seoul, 05030, Korea, Republic of
  • Korea University Guro Hospital
    Seoul, 08308, Korea, Republic of
  • The Catholic University of Korea Seoul St. Mary's Hospital
    Seoul, 137-701, Korea, Republic of
  • Yonsei University Wonju Severance Christian Hospital
    Wonju-Si, 220-701, Korea, Republic of
  • Medizinische Universität Innsbruck
    Innsbruck, 6020, Austria
  • LKH - Universitätsklinikum der PMU Salzburg
    Salzburg, 5020, Austria
  • Medizinische Universität Wien
    Wien, 1090, Austria
  • Wilhelminenspital der Stadt Wien
    Wien, 1160, Austria
  • Ogyi, Orszagos Gyogyszereszeti Intezet
    Budapest, 1051, Hungary
  • Semmelweis Egyetem
    Budapest, 1083, Hungary
  • Orszagos Onkologiai Intezet
    Budapest, 1122, Hungary
  • Petz Aladar Megyei Oktato Korhaz; Gyogyszereszeti Osztaly
    Gyor, 9024, Hungary
  • Somogy Megyei Kaposi Mor Oktato Korhaz
    Pecs, 7624, Hungary
  • Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin.Kozp.
    Szeged, 6720, Hungary
  • Azienda Ospedaliera Città della Salute e della Scienza di Torino; Radiology
    Torino, Abruzzo, 00126, Italy
  • Azienda Ospedaliero Universitaria San Martino
    Genova, Liguria, 16132, Italy
  • Asst Papa Giovanni XXIII; USC Farmacia
    Bergamo, Lombardia, 24127, Italy
  • Ospedale San Raffaele
    Milano, Lombardia, 20132, Italy
  • Asst Grande Ospedale Metropolitano Niguarda; SC Farmacia Ospedale
    Milano, Lombardia, 20162, Italy
  • Azienda Ospedaliero Universitaria Ospedali Riuniti
    Torrette Di Ancona, Marche, 60126, Italy
  • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
    Bari, Puglia, 70124, Italy
  • Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
    Bari, Puglia, 70124, Italy
  • Azienda Ospedaliera Universitaria Careggi
    Firenze, Toscana, 50141, Italy
  • Azienda Ospedaliero Universitaria Pisana; U.O. Farmaceutica
    Pisa, Toscana, 56100, Italy
  • Azienda Ospedaliera Di Padova
    Padova, Veneto, 35128, Italy
  • North Shore Hospital; Haematolgy
    Auckland, 1309, New Zealand
  • Middlemore Hospital
    Auckland, New Zealand
  • Baxter Healthcare
    Aukland, 1060, New Zealand
  • Christchurch Hospital NZ
    Christchurch, 8011, New Zealand
  • Kaohsiung Chang Gung Memorial Hospital
    Kaohsiung City, 00833, Taiwan
  • Kaohsiung Medical Uni Chung-Ho Memorial Hospital; Dept of Internal Medicine
    Kaohsiung, 807, Taiwan
  • China Medical University Hospital
    Taichung, 40447, Taiwan
  • Taichung Veterans General Hospital
    Taichung, 407, Taiwan
  • National Cheng Kung Univ Hosp
    Tainan, 00704, Taiwan
  • National Taiwan University Hospital
    Taipei, 10002, Taiwan
  • Chang Gung Medical Foundation - LINKOU; Dept of Cardiology
    Taoyuan County, 00333, Taiwan
  • The Canberra Hospital
    Garran, Australian Capital Territory, 2065, Australia
  • Concord Repatriation General Hospital
    Concord, New South Wales, 2139, Australia
  • St George Hospital
    Kogarah, New South Wales, New South Wales, 2217, Australia
  • Princess Alexandra Hospital
    Woolloongabba, Queensland, 4102, Australia
  • Royal Adelaide Hospital
    Adelaide, South Australia, 5000, Australia
  • Flinders Medical Centre
    Bedford Park, South Australia, 5042, Australia
  • Royal Hobart Hospital
    Hobart, Tasmania, 7000, Australia
  • Frankston Hospital
    Frankston, Victoria, 3199, Australia
  • Monash Medical Centre; Haematology
    Melbourne, Victoria, 3168, Australia
  • Peter MacCallum Cancer Center
    Melbourne, Victoria, Australia
  • Slade Health Pharmacy
    Mount Waverley, Victoria, 3149, Australia
  • Royal Melbourne Hospital
    Parkville, Victoria, 3050, Australia
  • The Perth Blood Institute
    Nedlands, Western Australia, 6009, Australia

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT02005471
Phase
Phase 3
Study Type
Interventional
Last Updated
April 27, 2018