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)
MURANO
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
2 other identifiers
interventional
389
19 countries
98
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2014
Longer than P75 for phase_3
98 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2013
CompletedFirst Posted
Study publicly available on registry
December 9, 2013
CompletedStudy Start
First participant enrolled
March 17, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 8, 2017
CompletedResults Posted
Study results publicly available
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 3, 2022
CompletedOctober 17, 2023
September 1, 2023
3.1 years
December 4, 2013
May 3, 2018
September 22, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With PD as Assessed by the Investigator Using Standard International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines or Death
Assessment of response was performed by the investigator according to the iwCLL guidelines. PD was defined as occurrence of one of the following events: appearance of any new extra nodal lesion; new palpable lymph node (greater than \[\>\] 1.5 centimeters \[cm\]); unequivocal progression of non-target lesion; an increase of greater than or equal to (\>/=) 50 percent (%) compared to baseline in splenomegaly, hepatomegaly, number of blood lymphocytes with lymphocyte count \>/=5000 per microliter (mcL), or in longest diameter of any extra nodal lesion; transformation to a more aggressive histology; decrease of \>/=50% compared to baseline in platelet or neutrophil count; or decrease in hemoglobin level by \>2 grams per deciliter (g/dL) or to less than \[\<\] 10 g/dL. Percentages are rounded off.
Baseline up to PD or death from any cause, whichever occurred first (up to approximately 8 years 5 months)
Progression-Free Survival (PFS) as Assessed by the Investigator Using Standard iwCLL Guidelines
PFS was defined as the time from randomization until first occurrence of PD/relapse as assessed by the investigator using iwCLL guidelines, or death from any cause, whichever occurred first. PD: occurrence of one of the following: new lesion; new palpable lymph node (\>1.5 cm); unequivocal progression of non-target lesion; increase of \>/=50% in splenomegaly, hepatomegaly, blood lymphocytes with count \>/=5000/mcL, longest diameter of any lesion; transformation to more aggressive histology; decrease of \>/=50% in platelet or neutrophil count, or hemoglobin level by \>2 g/dL or to \<10 g/dL. Participants who had not progressed, relapsed, or died at the time of analysis, were censored on the date of last assessment. In case of no disease assessment after baseline, PFS was censored at the time of randomization+1 day. The median PFS was estimated using Kaplan-Meier method and the 95% confidence interval (CI) was computed using method of Brookmeyer and Crowley.
Baseline up to PD or death, whichever occurred first (up to approximately 8 years 5 months)
Secondary Outcomes (26)
Percentage of Participants With PD or Death as Assessed by the Independent Review Committee (IRC) Using Standard iwCLL Guidelines
Baseline up to PD or death, whichever occurred first (up to approximately 3 years)
PFS as Assessed by the IRC Using Standard iwCLL Guidelines
Baseline up to PD or death, whichever occurred first (up to approximately 3 years)
Percentage of Participants With PD or Death as Assessed by the Investigator Using Standard iwCLL Guidelines in Participants With 17p Deletion as Identified by Fluorescence In-situ Hybridization (FISH) Test
Baseline up to PD or death, whichever occurred first (up to approximately 8 years 5 months)
PFS as Assessed by the Investigator Using Standard iwCLL Guidelines in Participants With 17p Deletion as Identified by FISH Test
Baseline up to PD or death, whichever occurred first (up to approximately 8 years 5 months)
Percentage of Participants With PD or Death as Assessed by the IRC Using Standard iwCLL Guidelines in Participants With 17p Deletion as Identified by FISH Test
Baseline up to PD or death, whichever occurred first (up to approximately 3 years)
- +21 more secondary outcomes
Other Outcomes (1)
Change From Baseline in Lymphocyte Subset Counts at Specified Time Points
Baseline, C4D14-28, Study Treatment Completion/Early Withdrawal (STC/EW, up to C6D28), EoCTR visit (8 to 12 weeks after C6D1), and at FUVs (every 12 weeks after EoCTR up to 3 years); Cycle length = 28 days
Study Arms (4)
Bendamustine + Rituximab
ACTIVE COMPARATORParticipants 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.
Venetoclax + Rituximab
EXPERIMENTALParticipants 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.
Bendamustine + Rituximab Crossover Substudy
EXPERIMENTALParticipants 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 + Rituximab Re-Treatment
EXPERIMENTALParticipants 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.
Interventions
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 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 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.
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify 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
- +23 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hoffmann-La Rochelead
- AbbViecollaborator
Study Sites (111)
University of California San Diego Medical Center
La Jolla, California, 92093-5354, 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
Vienna, 1090, Austria
Klinik Ottakring
Vienna, 1160, Austria
ZNA Antwerpen; Department Hematology
Antwerp, 2060, Belgium
Cliniques Universitaires Saint-Luc; Hematology
Brussels, 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 2T9, Canada
Juravinski Cancer Clinic
Hamilton, Ontario, L8N 3Z5, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Saskatoon City Hospital;Saskatchewan Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4, Canada
Fakultni nemocnice Brno
Brno, 613 00, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05, Czechia
Fakultní nemocnice Olomouc
Olomouc, 775 20, Czechia
Fakultni nemocnice Ostrava
Ostrava - Poruba, 708 52, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 34, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 128 08, 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, 85925, 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-Bénite, 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
Vandœuvre-lès-Nancy, 54511, France
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
Dresden, 01307, Germany
Universitaetsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
Universitätsklinikum Tübingen
Tübingen, 72076, Germany
Semmelweis Egyetem
Budapest, 1088, Hungary
Orszagos Onkologiai Intezet
Budapest, 1122, Hungary
Debreceni Egyetem Klinikai Központ; B?rgyógyászati Klinika
Debrecen, 4012, Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz
Pécs, 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
Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
Bari, Apulia, 70124, Italy
Azienda Ospedaliero Universitaria San Martino
Genoa, Liguria, 16132, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
Bergamo, Lombardy, 24127, Italy
Ospedale San Raffaele
Milan, Lombardy, 20132, Italy
Asst Grande Ospedale Metropolitano Niguarda; SC Farmacia Ospedale
Milan, Lombardy, 20162, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti
Torrette Di Ancona, The Marches, 60126, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, 50134, Italy
Azienda Ospedaliera Di Padova
Padua, Veneto, 35128, Italy
Amsterdam UMC, Locatie VUMC; Neurology
Amsterdam, 1081 HV, Netherlands
Amsterdam UMC Location AMC
Amsterdam, 1105 AZ, Netherlands
Albert Schweitzer Ziekenhuis, Dordwijk; Internal Medicine, Hemato-Oncology
Dordrecht, 3318 AT, Netherlands
Medisch Spectrum Twente
Enschede, 7512 KZ, Netherlands
Leids Universitair Medisch Centrum; Cardiology
Leiden, 2333 ZA, Netherlands
Erasmus Medisch Centrum
Rotterdam, 3000 CA, 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
Chorzów, 41-500, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Lodz, 93-513, Poland
Szpital Wojewodzki w Opolu
Opole, 45-061, Poland
MTZ Clinical Research Sp. z o.o.
Warsaw, 02-106, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1
Zabrze, 44803, Poland
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
Moscow, Moscow Oblast, 115478, Russia
SRI of Hematology and Transfusiology
Saint Petersburg, Sankt-Peterburg, 191024, Russia
North-West Federal Medical Research Center n.a. V.A. Almazov
Saint Petersburg, Sankt-Peterburg, 197341, Russia
Kemerovo Regional Clinical Hospital
Kemerovo, 650066, Russia
BHI of Omsk region Clinical Oncology Dispensary
Omsk, 644013, Russia
Seoul National University Bundang Hospital
Seongnam-si, 463-707, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Konkuk University Medical Center
Seoul, 05030, South Korea
The Catholic University of Korea Seoul St. Mary?s Hospital
Seoul, 6591, South Korea
Complejo Hospitalario de Navarra
Pamplona, Navarre, 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 85, Sweden
Akademiska Sjukhuset
Uppsala, 751 85, Sweden
National Taiwan University Hospital
Taipei, 10002, Taiwan
Bristol Haematology and Oncology centre
Bristol, BS2 8ED, 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
Related Publications (7)
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.
PMID: 40009494DERIVEDBadawi 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.
PMID: 35829925DERIVEDSeymour 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.
PMID: 35605176DERIVEDKater 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.
PMID: 32986498DERIVEDKater 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.
PMID: 30523712DERIVEDSeymour 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.
PMID: 29562156DERIVEDJones 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.
PMID: 27233802DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2013
First Posted
December 9, 2013
Study Start
March 17, 2014
Primary Completion
May 8, 2017
Study Completion
August 3, 2022
Last Updated
October 17, 2023
Results First Posted
October 1, 2018
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will share
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).