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)
NCT ID: NCT02005471
Last Updated: 2023-10-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
389 participants
INTERVENTIONAL
2014-03-17
2022-08-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Bendamustine + Rituximab
Participants will receive bendamustine 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 followed by 500 mg/m\^2 on Day 1 of Cycles 2-6.
Bendamustine
Bendamustine will be administered at a dose of 70 mg/m\^2 via IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Rituximab
Rituximab will be administered at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
R/C Substudy: Following the venetoclax ramp-up period, rituximab will be administered for 6 cycles consisting of a single infusion on the first day of each 28-day cycle.
Venetoclax + Rituximab
Participants will be initially placed on a venetoclax 5 weeks ramp-up period, and will receive an initial dose of 20 milligrams (mg) via tablet orally once daily (QD). Then the dose will be incremented weekly up to a maximum dose of 400 mg. Participants will then continue receiving venetoclax 400 mg QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards, as directed by the investigator, in combination with rituximab 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 followed by 500 mg/m\^2 on Day 1 of Cycles 2-6.
Venetoclax
Venetoclax will be administered at an initial dose of 20 mg via tablet orally QD, incremented weekly up to a maximum dose of 400 mg during a 5-week ramp-up period. Venetoclax will be continued at 400 mg QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to disease progression (PD) or 2 years, whichever occurs first.
R/C Substudy: venetoclax will be administered for 5-week dose ramp-up period to reach the target dose of 400 mg QD. Venetoclax will continue to be administered during the rituximab cycles until disease progression or for a maximum of 2 years from Cycle 1R/C Day 1 of the R/C Substudy.
Rituximab
Rituximab will be administered at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
R/C Substudy: Following the venetoclax ramp-up period, rituximab will be administered for 6 cycles consisting of a single infusion on the first day of each 28-day cycle.
Bendamustine + Rituximab Crossover Substudy
Participants entering the Crossover Substudy will have a 5-week venetoclax dose ramp-up period to reach the target dose of 400 mg QD. Following the venetoclax ramp-up period, Participants will receive 6 cycles of rituximab consisting of a single infusion on the first day of each 28-day cycle. Participants will continue to take their daily dose of venetoclax during the rituximab cycles. Participants who have not progressed following the completion of the 6 cycles will continue to receive venetoclax monotherapy until disease progression or for a maximum of 2 years from Cycle 1 Crossover Day 1 of the Substudy.
Venetoclax
Venetoclax will be administered at an initial dose of 20 mg via tablet orally QD, incremented weekly up to a maximum dose of 400 mg during a 5-week ramp-up period. Venetoclax will be continued at 400 mg QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to disease progression (PD) or 2 years, whichever occurs first.
R/C Substudy: venetoclax will be administered for 5-week dose ramp-up period to reach the target dose of 400 mg QD. Venetoclax will continue to be administered during the rituximab cycles until disease progression or for a maximum of 2 years from Cycle 1R/C Day 1 of the R/C Substudy.
Rituximab
Rituximab will be administered at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
R/C Substudy: Following the venetoclax ramp-up period, rituximab will be administered for 6 cycles consisting of a single infusion on the first day of each 28-day cycle.
Venetoclax + Rituximab Re-Treatment
Participants entering the Re-Treatment Substudy will have a 5-week venetoclax dose ramp-up period to reach the target dose of 400 mg QD. Following the venetoclax ramp-up period, Participants will receive 6 cycles of rituximab consisting of a single infusion on the first day of each 28-day cycle. Participants will continue to take their daily dose of venetoclax during the rituximab cycles. Participants who have not progressed following the completion of the 6 cycles will continue to receive venetoclax monotherapy until disease progression or for a maximum of 2 years from Cycle 1 Re-Treatment Day 1 of the Substudy.
Venetoclax
Venetoclax will be administered at an initial dose of 20 mg via tablet orally QD, incremented weekly up to a maximum dose of 400 mg during a 5-week ramp-up period. Venetoclax will be continued at 400 mg QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to disease progression (PD) or 2 years, whichever occurs first.
R/C Substudy: venetoclax will be administered for 5-week dose ramp-up period to reach the target dose of 400 mg QD. Venetoclax will continue to be administered during the rituximab cycles until disease progression or for a maximum of 2 years from Cycle 1R/C Day 1 of the R/C Substudy.
Rituximab
Rituximab will be administered at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
R/C Substudy: Following the venetoclax ramp-up period, rituximab will be administered for 6 cycles consisting of a single infusion on the first day of each 28-day cycle.
Interventions
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Bendamustine
Bendamustine will be administered at a dose of 70 mg/m\^2 via IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Venetoclax
Venetoclax will be administered at an initial dose of 20 mg via tablet orally QD, incremented weekly up to a maximum dose of 400 mg during a 5-week ramp-up period. Venetoclax will be continued at 400 mg QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to disease progression (PD) or 2 years, whichever occurs first.
R/C Substudy: venetoclax will be administered for 5-week dose ramp-up period to reach the target dose of 400 mg QD. Venetoclax will continue to be administered during the rituximab cycles until disease progression or for a maximum of 2 years from Cycle 1R/C Day 1 of the R/C Substudy.
Rituximab
Rituximab will be administered at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
R/C Substudy: Following the venetoclax ramp-up period, rituximab will be administered for 6 cycles consisting of a single infusion on the first day of each 28-day cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
* 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
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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University of California San Diego Medical Center
La Jolla, California, United States
Henry Ford Health System
Detroit, Michigan, United States
Memorial Sloan Kettering Cancer Center; Clinical Trials Office
New York, New York, United States
Perlmutter Cancer Center NYU Langone Health
New York, New York, United States
Huntsman Cancer Institute; University of Utah
Salt Lake City, Utah, United States
The Canberra Hospital
Garran, Australian Capital Territory, Australia
Concord Repatriation General Hospital
Concord, New South Wales, Australia
St George Hospital
Kogarah, New South Wales, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
Frankston Hospital
Frankston, Victoria, Australia
Monash Medical Centre; Haematology
Melbourne, Victoria, Australia
Slade Health Pharmacy
Mount Waverley, Victoria, Australia
Peter MacCallum Cancer Center
North Melbourne, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
The Perth Blood Institute
Nedlands, Western Australia, Australia
Medizinische Universität Innsbruck
Innsbruck, , Austria
LKH - Universitätsklinikum der PMU Salzburg
Salzburg, , Austria
Medizinische Universität Wien
Vienna, , Austria
Klinik Ottakring
Vienna, , Austria
ZNA Antwerpen; Department Hematology
Antwerp, , Belgium
Cliniques Universitaires Saint-Luc; Hematology
Brussels, , Belgium
AZ Groeninge
Kortrijk, , Belgium
UZ Leuven; Department Hematology
Leuven, , Belgium
CHU UCL Mont-Godinne
Mont-godinne, , Belgium
AZ Delta (Campus Rumbeke)
Roeselare, , Belgium
Foothills Medical Centre; Centre Dept of Medical Clinical Neuroscience
Calgary, Alberta, Canada
Juravinski Cancer Clinic
Hamilton, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Saskatoon City Hospital;Saskatchewan Cancer Centre
Saskatoon, Saskatchewan, Canada
Fakultni nemocnice Brno
Brno, , Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Fakultní nemocnice Olomouc
Olomouc, , Czechia
Fakultni nemocnice Ostrava
Ostrava - Poruba, , Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, , Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Herlev Hospital
Herlev, , Denmark
Rigshospitalet
København Ø, , Denmark
Odense Universitetshospital
Odense C, , Denmark
Sjællands Universitetshospital, Roskilde
Roskilde, , Denmark
Sygehus Lillebælt, Vejle
Vejle, , Denmark
Hôpital Morvan
Brest, , France
Centre Hospitalier Départemental Les Oudairies
La Roche-sur-Yon, , France
Hopital Claude Huriez - CHU Lille
Lille, , France
Hopital Saint Eloi
Montpellier, , France
CHU Nantes - Hôtel Dieu; Service Assistance Medicale à la Procreation
Nantes, , France
Hopital Robert Debre
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
CHU Poitiers - Hopital La Miletrie
Poitiers, , France
CHU de Rennes - Hopital de Pontchaillo
Rennes, , France
Centre Henri Becquerel
Rouen, , France
Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)
Toulouse, , France
CHU Tours - Hôpital Bretonneau
Tours, , France
Hôpital de Brabois Adultes
Vandœuvre-lès-Nancy, , France
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
Dresden, , Germany
Universitaetsklinikum Freiburg
Freiburg im Breisgau, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
Semmelweis Egyetem
Budapest, , Hungary
Orszagos Onkologiai Intezet
Budapest, , Hungary
Debreceni Egyetem Klinikai Központ; B?rgyógyászati Klinika
Debrecen, , Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz
Pécs, , Hungary
Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin.Kozp.
Szeged, , Hungary
Azienda Ospedaliera Città della Salute e della Scienza di Torino; Radiology
Torino, Abruzzo, Italy
Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
Bari, Apulia, Italy
Azienda Ospedaliero Universitaria San Martino
Genoa, Liguria, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
Bergamo, Lombardy, Italy
Ospedale San Raffaele
Milan, Lombardy, Italy
Asst Grande Ospedale Metropolitano Niguarda; SC Farmacia Ospedale
Milan, Lombardy, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti
Torrette Di Ancona, The Marches, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, Italy
Azienda Ospedaliera Di Padova
Padua, Veneto, Italy
Amsterdam UMC, Locatie VUMC; Neurology
Amsterdam, , Netherlands
Amsterdam UMC Location AMC
Amsterdam, , Netherlands
Albert Schweitzer Ziekenhuis, Dordwijk; Internal Medicine, Hemato-Oncology
Dordrecht, , Netherlands
Medisch Spectrum Twente
Enschede, , Netherlands
Leids Universitair Medisch Centrum; Cardiology
Leiden, , Netherlands
Erasmus Medisch Centrum
Rotterdam, , Netherlands
UMC Utrecht
Utrecht, , Netherlands
North Shore Hospital; Haematolgy
Auckland, , New Zealand
Middlemore Hospital
Auckland, , New Zealand
Christchurch Hospital NZ
Christchurch, , New Zealand
Baxter Healthcare
Mount Wellington, , New Zealand
SP ZOZ Zespol Szpitali Miejskich w Chorzowie
Chorzów, , Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Lodz, , Poland
Szpital Wojewodzki w Opolu
Opole, , Poland
MTZ Clinical Research Sp. z o.o.
Warsaw, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 1
Zabrze, , Poland
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
Moscow, Moscow Oblast, Russia
SRI of Hematology and Transfusiology
Saint Petersburg, Sankt-Peterburg, Russia
North-West Federal Medical Research Center n.a. V.A. Almazov
Saint Petersburg, Sankt-Peterburg, Russia
Kemerovo Regional Clinical Hospital
Kemerovo, , Russia
BHI of Omsk region Clinical Oncology Dispensary
Omsk, , Russia
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Konkuk University Medical Center
Seoul, , South Korea
The Catholic University of Korea Seoul St. Mary?s Hospital
Seoul, , South Korea
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Clinic i Provincial de Barcelona; Hematology
Barcelona, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Clinico Universitario de Salamanca
Salamanca, , Spain
Skånes Universitetssjukhus
Lund, , Sweden
Akademiska Sjukhuset
Uppsala, , Sweden
National Taiwan University Hospital
Taipei, , Taiwan
Bristol Haematology and Oncology centre
Bristol, , United Kingdom
The Christie
Manchester, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Singleton Hospital; Pharmacy Department
Swansea, , United Kingdom
Countries
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References
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Kater AP, Harrup R, Kipps TJ, Eichhorst B, Owen CJ, Assouline S, Lamanna N, Robak T, de la Serna J, Jaeger U, Cartron G, Montillo M, Mellink C, Langerak AW, Chyla B, Popovic R, Jiang Y, Millen R, Lefebure M, Thadani-Mulero M, Boyer M, Seymour JF. The MURANO study: final analysis and retreatment/crossover substudy results of VenR for patients with relapsed/refractory CLL. Blood. 2025 Jun 5;145(23):2733-2745. doi: 10.1182/blood.2024025525.
Badawi M, Chen X, Marroum P, Suleiman AA, Mensing S, Koenigsdorfer A, Schiele JT, Palenski T, Samineni D, Hoffman D, Menon R, Salem AH. Bioavailability Evaluation of Venetoclax Lower-Strength Tablets and Oral Powder Formulations to Establish Interchangeability with the 100 mg Tablet. Clin Drug Investig. 2022 Aug;42(8):657-668. doi: 10.1007/s40261-022-01172-4. Epub 2022 Jul 13.
Seymour JF, Kipps TJ, Eichhorst BF, D'Rozario J, Owen CJ, Assouline S, Lamanna N, Robak T, de la Serna J, Jaeger U, Cartron G, Montillo M, Mellink C, Chyla B, Panchal A, Lu T, Wu JQ, Jiang Y, Lefebure M, Boyer M, Kater AP. Enduring undetectable MRD and updated outcomes in relapsed/refractory CLL after fixed-duration venetoclax-rituximab. Blood. 2022 Aug 25;140(8):839-850. doi: 10.1182/blood.2021015014.
Kater AP, Wu JQ, Kipps T, Eichhorst B, Hillmen P, D'Rozario J, Assouline S, Owen C, Robak T, de la Serna J, Jaeger U, Cartron G, Montillo M, Dubois J, Eldering E, Mellink C, Van Der Kevie-Kersemaekers AM, Kim SY, Chyla B, Punnoose E, Bolen CR, Assaf ZJ, Jiang Y, Wang J, Lefebure M, Boyer M, Humphrey K, Seymour JF. Venetoclax Plus Rituximab in Relapsed Chronic Lymphocytic Leukemia: 4-Year Results and Evaluation of Impact of Genomic Complexity and Gene Mutations From the MURANO Phase III Study. J Clin Oncol. 2020 Dec 1;38(34):4042-4054. doi: 10.1200/JCO.20.00948. Epub 2020 Sep 28.
Kater AP, Seymour JF, Hillmen P, Eichhorst B, Langerak AW, Owen C, Verdugo M, Wu J, Punnoose EA, Jiang Y, Wang J, Boyer M, Humphrey K, Mobasher M, Kipps TJ. Fixed Duration of Venetoclax-Rituximab in Relapsed/Refractory Chronic Lymphocytic Leukemia Eradicates Minimal Residual Disease and Prolongs Survival: Post-Treatment Follow-Up of the MURANO Phase III Study. J Clin Oncol. 2019 Feb 1;37(4):269-277. doi: 10.1200/JCO.18.01580. Epub 2018 Dec 3.
Seymour JF, Kipps TJ, Eichhorst B, Hillmen P, D'Rozario J, Assouline S, Owen C, Gerecitano J, Robak T, De la Serna J, Jaeger U, Cartron G, Montillo M, Humerickhouse R, Punnoose EA, Li Y, Boyer M, Humphrey K, Mobasher M, Kater AP. Venetoclax-Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia. N Engl J Med. 2018 Mar 22;378(12):1107-1120. doi: 10.1056/NEJMoa1713976.
Jones AK, Freise KJ, Agarwal SK, Humerickhouse RA, Wong SL, Salem AH. Clinical Predictors of Venetoclax Pharmacokinetics in Chronic Lymphocytic Leukemia and Non-Hodgkin's Lymphoma Patients: a Pooled Population Pharmacokinetic Analysis. AAPS J. 2016 Sep;18(5):1192-1202. doi: 10.1208/s12248-016-9927-9. Epub 2016 May 27.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2013-002110-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GO28667
Identifier Type: -
Identifier Source: org_study_id
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