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Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL)
Sponsor: Pharmacyclics LLC.
Summary
This is a multicenter, 2-cohort Phase 2 study assessing both minimal residual disease (MRD)-guided discontinuation and fixed duration therapy with the combination of ibrutinib + venetoclax in subjects with treatment-naïve CLL or SLL.
Official title: Phase 2 Study of the Combination of Ibrutinib Plus Venetoclax in Subjects With Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
323
Start Date
2016-09-28
Completion Date
2024-03-27
Last Updated
2026-09-10
Healthy Volunteers
No
Interventions
ibrutinib
ibrutinib administered orally once daily (three 140 mg capsules)
venetoclax
venetoclax tablets will be administered orally once daily starting with a 5 week ramp up of 20 mg, 50 mg, 100 mg, 200 mg and 400 mg. After ramp up, venetoclax will be administered at 400 mg.
Placebo
placebo capsules to match ibrutinib administered orally once daily
Locations (46)
City of Hope /ID# 1142-0047
Duarte, California, United States
Moores Cancer Center at UC San Diego /ID# 1142-0241
La Jolla, California, United States
UC Irvine Medical Center - Chao Family Comprehensive Cancer Center /ID# 1142-0008
Orange, California, United States
Norton Cancer Center /ID# 1142-0071
Louisville, Kentucky, United States
Rutgers Cancer Institute of New Jersey /ID# 1142-1193
New Brunswick, New Jersey, United States
Northwell Health/Long Island Jewish Hospital /ID# 1142-0350
New Hyde Park, New York, United States
New York Presbyterian Hospital/Weill Cornell Med College /ID# 1142-0200
New York, New York, United States
University of Rochester Cancer Center /ID# 1142-0127
Rochester, New York, United States
Charlotte-Mecklenberg Hospital, Carolinas Healthcare System, Levine Cancer Inst /ID# 1142-0733
Charlotte, North Carolina, United States
Cleveland Clinic Foundation /ID# 1142-0739
Cleveland, Ohio, United States
University of Pennsylvania /ID# 1142-0069
Philadelphia, Pennsylvania, United States
Tennessee Oncology - Chattanooga /ID# 1142-0123
Chattanooga, Tennessee, United States
MD Anderson Cancer Center /ID# 1142-0032
Houston, Texas, United States
Swedish Cancer Institute /ID# 1142-0114
Seattle, Washington, United States
St George Hospital /ID# 1142-0654
Kogarah, New South Wales, Australia
Flinders Medical Centre /ID# 1142-0163
Bedford Park, South Australia, Australia
Monash Medical Centre /ID# 1142-0556
Clayton, Victoria, Australia
Peter MacCallum Cancer Centre-East Melbourne /ID# 1142-0633
East Melbourne, Victoria, Australia
St Vincent's Hospital Melbourne /ID# 1142-0501
Fitzroy, Victoria, Australia
Frankston Hospital /ID# 1142-0715
Frankston, Victoria, Australia
Austin Health /ID# 1142-0170
Heidelberg, Victoria, Australia
Ospedale San Raffaele IRCCS /ID# 1142-0523
Milan, Lombardy, Italy
Ospedale Policlinico San Martino /ID# 1142-0903
Genova, Italy
ASST Grande Ospedale Metropolitano Niguarda /ID# 1142-0581
Milan, Italy
Azienda Ospedaliero-Universitaria di Modena /ID# 1142-0524
Modena, Italy
Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 1142-0582
Novara, Italy
Azienda Ospedaliera di Padova /ID# 1142-1175
Padova, Italy
Azienda USL di Piacenza - Ospedale Guglielmo da Saliceto /ID# 1142-1182
Piacenza, Italy
Middlemore Hospital /ID# 1142-0662
Otahuhu, Auckland, New Zealand
Christchurch Hospital /ID# 1142-0589
Christchurch, Canterbury, New Zealand
Palmerston North Hospital /ID# 1142-0585
Palmerston North, Manawatu-Wanganui, New Zealand
North Shore Hospital /ID# 1142-0663
Auckland, New Zealand
Malopolskie Centrum Medyczne /ID# 1142-0364
Krakow, Lesser Poland Voivodeship, Poland
Duplicate_Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie /ID# 1142-0590
Lublin, Lublin Voivodeship, Poland
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. ks. B. /ID# 1142-0592
Brzozów, Podkarpackie Voivodeship, Poland
Samodzielny Publiczny Szpital Klinczny Nr-1- Akademickie Cenrum Klinic /ID# 1142-0529
Gdansk, Pomeranian Voivodeship, Poland
Medical Univ. of Lodz and Copernicus Memorial Hospital /ID# 1142-0531
Lodz, Poland
Hospital Duran i Reynals /ID# 1142-0604
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Puerta de Hierro, Majadahonda /ID# 1142-0536
Majadahonda, Madrid, Spain
Complejo Hospitalario de Navarra /ID# 1142-1197
Pamplona, Navarre, Spain
Hospital Clinic de Barcelona /ID# 1142-0533
Barcelona, Spain
Hospital Santa Creu i Sant Pau /ID# 1142-0535
Barcelona, Spain
Hospital Universitario Virgen de las Nieves /ID# 1142-1196
Granada, Spain
Hospital Universitario Ramon y Cajal /ID# 1142-0874
Madrid, Spain
Hospital Universitario 12 de Octubre /ID# 1142-0864
Madrid, Spain
Hospital Clinico Universitario de Salamanca /ID# 1142-0790
Salamanca, Spain