Chronic Lymphocytic Leukemia Clinical Trial
Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL)
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 leukemia-cll/" >CLL or SLL.
View Eligibility Criteria
Eligibility Criteria
Inclusion Criteria:
Diagnosis of CLL/SLL that meets 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) diagnostic criteria (Hallek et al), with active disease meeting at least 1 IWCLL criteria for requiring treatment.
Measurable nodal disease by computed tomography (CT)
Adequate hepatic, and renal function
Adequate hematologic function
absolute neutrophil count >750/µL
platelet count >30,000 /μL
hemoglobin >8.0 g/dL
Exclusion Criteria:
Any prior therapy used for treatment of CLL/SLL
Known allergy to xanthine oxidase inhibitors and/or rasburicase for subjects at risk for tumor lysis syndrome (TLS)
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There are 46 Locations for this study
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City of Hope /ID# 1142-0047
Duarte California, 91010, United States
Duarte California, 91010, United States
Moores Cancer Center at UC San Diego /ID# 1142-0241
La Jolla California, 92093, United States
La Jolla California, 92093, United States
UC Irvine Medical Center - Chao Family Comprehensive Cancer Center /ID# 1142-0008
Orange California, 92868, United States
Orange California, 92868, United States
Norton Cancer Center /ID# 1142-0071
Louisville Kentucky, 40202, United States
Louisville Kentucky, 40202, United States
Rutgers Cancer Institute of New Jersey /ID# 1142-1193
New Brunswick New Jersey, 08901, United States
New Brunswick New Jersey, 08901, United States
Northwell Health/Long Island Jewish Hospital /ID# 1142-0350
New Hyde Park New York, 11042, United States
New Hyde Park New York, 11042, United States
New York Presbyterian Hospital/Weill Cornell Med College /ID# 1142-0200
New York New York, 10021, United States
New York New York, 10021, United States
University of Rochester Cancer Center /ID# 1142-0127
Rochester New York, 14642, United States
Rochester New York, 14642, United States
Charlotte-Mecklenberg Hospital, Carolinas Healthcare System, Levine Cancer Inst /ID# 1142-0733
Charlotte North Carolina, 28203, United States
Charlotte North Carolina, 28203, United States
Cleveland Clinic Foundation /ID# 1142-0739
Cleveland Ohio, 44195, United States
Cleveland Ohio, 44195, United States
University of Pennsylvania /ID# 1142-0069
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19104, United States
Tennessee Oncology - Chattanooga /ID# 1142-0123
Chattanooga Tennessee, 37404, United States
Chattanooga Tennessee, 37404, United States
MD Anderson Cancer Center /ID# 1142-0032
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Swedish Cancer Institute /ID# 1142-0114
Seattle Washington, 98104, United States
Seattle Washington, 98104, United States
St George Hospital /ID# 1142-0654
Kogarah New South Wales, 2217, Australia
Kogarah New South Wales, 2217, Australia
Flinders Medical Centre /ID# 1142-0163
Bedford Park South Australia, 5042, Australia
Bedford Park South Australia, 5042, Australia
Monash Medical Centre /ID# 1142-0556
Clayton Victoria, 3168, Australia
Clayton Victoria, 3168, Australia
Peter MacCallum Cancer Centre-East Melbourne /ID# 1142-0633
East Melbourne Victoria, 3002, Australia
East Melbourne Victoria, 3002, Australia
St Vincent's Hospital Melbourne /ID# 1142-0501
Fitzroy Victoria, 3065, Australia
Fitzroy Victoria, 3065, Australia
Frankston Hospital /ID# 1142-0715
Frankston Victoria, 3199, Australia
Frankston Victoria, 3199, Australia
Austin Health /ID# 1142-0170
Heidelberg Victoria, 3084, Australia
Heidelberg Victoria, 3084, Australia
Ospedale San Raffaele IRCCS /ID# 1142-0523
Milan Lombardia, 20132, Italy
Milan Lombardia, 20132, Italy
Ospedale Policlinico San Martino /ID# 1142-0903
Genova , 16132, Italy
Genova , 16132, Italy
ASST Grande Ospedale Metropolitano Niguarda /ID# 1142-0581
Milano , 20162, Italy
Milano , 20162, Italy
Azienda Ospedaliero-Universitaria di Modena /ID# 1142-0524
Modena , 41124, Italy
Modena , 41124, Italy
Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 1142-0582
Novara , 28100, Italy
Novara , 28100, Italy
Azienda Ospedaliera di Padova /ID# 1142-1175
Padova , 35128, Italy
Padova , 35128, Italy
Azienda USL di Piacenza - Ospedale Guglielmo da Saliceto /ID# 1142-1182
Piacenza , 29121, Italy
Piacenza , 29121, Italy
Middlemore Hospital /ID# 1142-0662
Otahuhu Auckland, 2025, New Zealand
Otahuhu Auckland, 2025, New Zealand
Christchurch Hospital /ID# 1142-0589
Christchurch Canterbury, 8011, New Zealand
Christchurch Canterbury, 8011, New Zealand
Palmerston North Hospital /ID# 1142-0585
Palmerston North Manawatu-Wanganui, 4414, New Zealand
Palmerston North Manawatu-Wanganui, 4414, New Zealand
North Shore Hospital /ID# 1142-0663
Auckland , 0622, New Zealand
Auckland , 0622, New Zealand
Duplicate_Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie /ID# 1142-0590
Lublin Lubelskie, 20-08, Poland
Lublin Lubelskie, 20-08, Poland
Malopolskie Centrum Medyczne /ID# 1142-0364
Krakow Malopolskie, 30-51, Poland
Krakow Malopolskie, 30-51, Poland
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. ks. B. /ID# 1142-0592
Brzozow Podkarpackie, 36-20, Poland
Brzozow Podkarpackie, 36-20, Poland
Samodzielny Publiczny Szpital Klinczny Nr-1- Akademickie Cenrum Klinic /ID# 1142-0529
Gdańsk Pomorskie, 80-95, Poland
Gdańsk Pomorskie, 80-95, Poland
Medical Univ. of Lodz and Copernicus Memorial Hospital /ID# 1142-0531
Lodz , 93-51, Poland
Lodz , 93-51, Poland
Hospital Duran i Reynals /ID# 1142-0604
Hospitalet de Llobregat Barcelona, 08907, Spain
Hospitalet de Llobregat Barcelona, 08907, Spain
Hospital Universitario Puerta de Hierro, Majadahonda /ID# 1142-0536
Majadahonda Madrid, 28222, Spain
Majadahonda Madrid, 28222, Spain
Complejo Hospitalario de Navarra /ID# 1142-1197
Pamplona Navarra, 31008, Spain
Pamplona Navarra, 31008, Spain
Hospital Clinic de Barcelona /ID# 1142-0533
Barcelona , 08036, Spain
Barcelona , 08036, Spain
Hospital Santa Creu i Sant Pau /ID# 1142-0535
Barcelona , 08041, Spain
Barcelona , 08041, Spain
Hospital Universitario Virgen de las Nieves /ID# 1142-1196
Granada , 18014, Spain
Granada , 18014, Spain
Hospital Universitario Ramon y Cajal /ID# 1142-0874
Madrid , 28034, Spain
Madrid , 28034, Spain
Hospital Universitario 12 de Octubre /ID# 1142-0864
Madrid , 28041, Spain
Madrid , 28041, Spain
Hospital Clinico Universitario de Salamanca /ID# 1142-0790
Salamanca , 37007, Spain
Salamanca , 37007, Spain
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