Chronic Lymphocytic Leukemia Clinical Trial

A Study to Evaluate the Benefit of Venetoclax Plus Rituximab Compared With Bendamustine Plus Rituximab in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

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 leukemia-cll/" >CLL. Participants will be randomly assigned in 1:1 ratio to receive either venetoclax + rituximab (Arm A) or bendamustine + rituximab (Arm B).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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 ( 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

Inclusion Criteria R/C Substudy:

Participants randomized to Arm A or Arm B with a confirmed disease progression of CLL per iwCLL criteria
Participants who have not received new anti-CLL therapy following disease progression in Arm A or Arm B
Adequate renal and hepatic function per laboratory reference range

Exclusion Criteria:

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 carcinoma in situ of the cervix that has been treated 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

Exclusion Criteria R/C Substudy:

Transformation of CLL to aggressive NHL (e.g., Richter's transformation, prolymphocytic leukemia, or DLBCL) or CNS involvement by CLL
Evidence of other clinically significant uncontrolled condition(s) including, but not limited to, uncontrolled systemic infection (viral, bacterial, or fungal)
Development of other malignancy since enrollment into the study, with the exception of curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia
History of severe (i.e., requiring permanent discontinuation of prior rituximab therapy) prior allergic or anaphylactic reactions to rituximab
Known HIV positivity
Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen [HbsAg] serology)
Positive test results for hepatitis C virus (HCV; HCV antibody serology testing)
Requires the use of warfarin (due to potential drug interactions that may potentially increase the exposure of warfarin)
Has not recovered to less than Grade 2 clinically significant adverse effect(s)/toxicity(ies) of any previous therapy
Received potent CYP3A4 inhibitors (such as fluconazole, ketoconazole, and clarithromycin) within 7 days prior to the first dose of study treatment
Received potent CYP3A4 inducers (such as rifampin, carbamazepine, phenytoin, St. John's wort) within 7 days prior to the first dose of study treatment
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
A significant history of renal, neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, or hepatic disease that, in the opinion of the investigator, would adversely affect the participants's participation in this study or interpretation of study outcomes
Major surgery within 30 days prior to the first dose of study treatment
A participant who is pregnant or breastfeeding
Malabsorption syndrome or other condition that precludes enteral route of administration
Known allergy to both xanthine oxidase inhibitors and rasburicase
Vaccination with a live vaccine within 28 days prior to randomization

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 3

Estimated Enrollment:

389

Study ID:

NCT02005471

Recruitment Status:

Completed

Sponsor:

Hoffmann-La Roche

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There are 108 Locations for this study

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University of California San Diego Medical Center
La Jolla California, 92093, United States
Henry Ford Health System
Detroit Michigan, 48202, United States
Memorial Sloan Kettering Cancer Center; Clinical Trials Office
New York New York, 10021, United States
Perlmutter Cancer Center NYU Langone Health
New York New York, 10032, United States
Huntsman Cancer Institute; University of Utah
Salt Lake City Utah, 84112, United States
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
Slade Health Pharmacy
Mount Waverley Victoria, 3149, Australia
Peter MacCallum Cancer Center
North Melbourne Victoria, 3051, Australia
Royal Melbourne Hospital
Parkville Victoria, 3050, Australia
The Perth Blood Institute
Nedlands Western Australia, 6009, Australia
Medizinische Universität Innsbruck
Innsbruck , 6020, Austria
LKH - Universitätsklinikum der PMU Salzburg
Salzburg , 5020, Austria
Medizinische Universität Wien
Wien , 1090, Austria
Klinik Ottakring
Wien , 1160, Austria
ZNA Antwerpen; Department Hematology
Antwerpen , 2060, Belgium
Cliniques Universitaires Saint-Luc; Hematology
Bruxelles , 1200, Belgium
AZ Groeninge
Kortrijk , 8500, Belgium
UZ Leuven; Department Hematology
Leuven , 3000, Belgium
CHU UCL Mont-Godinne
Mont-godinne , 5530, Belgium
AZ Delta (Campus Rumbeke)
Roeselare , 8800, Belgium
Foothills Medical Centre; Centre Dept of Medical Clinical Neuroscience
Calgary Alberta, T2N 2, Canada
Juravinski Cancer Clinic
Hamilton Ontario, L8N 3, Canada
Jewish General Hospital
Montreal Quebec, H3T 1, Canada
Saskatoon City Hospital;Saskatchewan Cancer Centre
Saskatoon Saskatchewan, S7N 4, Canada
Fakultni nemocnice Brno
Brno , 613 0, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Kralove , 500 0, Czechia
Fakultní nemocnice Olomouc
Olomouc , 775 2, Czechia
Fakultni nemocnice Ostrava
Ostrava - Poruba , 708 5, Czechia
Vseobecna fakultni nemocnice v Praze
Praha 2 , 128 0, Czechia
Fakultni nemocnice Kralovske Vinohrady
Praha , 100 3, Czechia
Herlev Hospital
Herlev , 2730, Denmark
Rigshospitalet
København Ø , 2100, Denmark
Odense Universitetshospital
Odense C , 5000, Denmark
Sjællands Universitetshospital, Roskilde
Roskilde , 4000, Denmark
Sygehus Lillebælt, Vejle
Vejle , 7100, Denmark
Hôpital Morvan
Brest , 29609, 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
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
Dresden , 01307, Germany
Universitaetsklinikum Freiburg
Freiburg , 79106, Germany
Universitätsklinikum Tübingen
Tübingen , 72076, Germany
Semmelweis Egyetem
Budapest , 1083, Hungary
Orszagos Onkologiai Intezet
Budapest , 1122, Hungary
Debreceni Egyetem Klinikai Központ; Bőrgyógyászati Klinika
Debrecen , 4012, 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, 10126, Italy
Azienda Ospedaliero Universitaria San Martino
Genova Liguria, 16132, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
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
Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
Bari Puglia, 70124, Italy
Azienda Ospedaliera Universitaria Careggi
Florence Toscana, 50134, Italy
Azienda Ospedaliera Di Padova
Padova Veneto, 35128, Italy
Seoul National University Bundang Hospital
Seongnam-si , 13605, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Konkuk University Medical Center
Seoul , 05030, Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul , 137-7, Korea, Republic of
Amsterdam UMC, Locatie VUMC; Neurology
Amsterdam , 1081 , Netherlands
Amsterdam UMC Location AMC
Amsterdam , 1105 , Netherlands
Albert Schweitzer Ziekenhuis, Dordwijk; Internal Medicine, Hemato-Oncology
Dordrecht , 3318 , Netherlands
Medisch Spectrum Twente
Enschede , 7512 , Netherlands
Leids Universitair Medisch Centrum; Cardiology
Leiden , 2333 , Netherlands
Erasmus Medisch Centrum Rotterdam; Lokatie Daniel den Hoed
Rotterdam , 3015 , Netherlands
UMC Utrecht
Utrecht , 3508 , Netherlands
North Shore Hospital; Haematolgy
Auckland , 1309, New Zealand
Middlemore Hospital
Auckland , , New Zealand
Christchurch Hospital NZ
Christchurch , 8011, New Zealand
Baxter Healthcare
Mount Wellington , 1060, New Zealand
SP ZOZ Zespol Szpitali Miejskich w Chorzowie
Chorzow , 41-50, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk , , Poland
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Lodz , 93-51, Poland
Szpital Wojewodzki w Opolu
Opole , 45-06, Poland
MTZ Clinical Research Sp. z o.o.
Warszawa , 02-10, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1
Zabrze , 44803, Poland
Kemerovo Regional Clinical Hospital
Kemerovo , 65006, Russian Federation
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
Moscow , 11547, Russian Federation
BHI of Omsk region Clinical Oncology Dispensary
Omsk , 64401, Russian Federation
SRI of Hematology and Transfusiology
St. Petersburg , 19102, Russian Federation
North-West Federal Medical Research Center n.a. V.A. Almazov
St. Petersburg , 19734, Russian Federation
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
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Hospital Clinico Universitario de Salamanca
Salamanca , 37007, Spain
Skånes Universitetssjukhus
Lund , 221 8, Sweden
Akademiska Sjukhuset
Uppsala , 751 8, Sweden
National Taiwan University Hospital
Taipei , 10002, Taiwan
Bristol Haematology and Oncology Centre
Bristol , BS2 8, United Kingdom
The Christie
Manchester , M20 4, United Kingdom
Southampton General Hospital
Southampton , SO16 , United Kingdom
Singleton Hospital; Pharmacy Department
Swansea , SA2 8, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 3

Estimated Enrollment:

389

Study ID:

NCT02005471

Recruitment Status:

Completed

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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