Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax With Intravenous (IV) Obinutuzumab in Adult Participants With Recurring Chronic Lymphocytic Leukemia (CLL)
NCT ID: NCT04895436
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
75 participants
INTERVENTIONAL
2022-03-28
2029-01-31
Brief Summary
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Venetoclax is an approved drug for the treatment of CLL. Study doctors put the participants in 1 of 2 groups, called cohorts, based on when symptoms of CLL came back after previous treatment in first-line. Approximately 75 adult participants with CLL who have been treated with venetoclax in combination with an anti-CD20 antibody +/- X will be enrolled in the study in approximately 60 sites worldwide.
Participants will receive intravenous (IV) obinutuzumab + oral venetoclax (VenG) in 28-day cycles for a total of 6 cycles per cohort, followed by 6 to 18 cycles of venetoclax alone, for a total treatment of 12 to 24 cycles, depending on the cohort.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1 - venetoclax + obinutuzumab
Participants will receive venetoclax + obinutuzumab for six 28-day cycles followed by venetoclax for six 28-day cycles.
Venetoclax
Oral tablet
Obinutuzumab
Intravenous (IV) infusion
Cohort 2 - venetoclax + obinutuzumab
Participants will receive venetoclax + obinutuzumab for six 28-day cycles followed by venetoclax for eighteen 28-day cycles.
Venetoclax
Oral tablet
Obinutuzumab
Intravenous (IV) infusion
Interventions
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Venetoclax
Oral tablet
Obinutuzumab
Intravenous (IV) infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Previously completed venetoclax + anti-CD20 antibody +/- X regimen as a fixed duration first-line (1L) therapy and achieved documented response, defined as complete remission, complete remission with incomplete marrow recovery, partial remission, or nodular partial remission.
* More than 24 months (Cohort 1) or 12-24 months (Cohort 2) have elapsed between last dose of venetoclax and disease progression after completion of 1L treatment.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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F. Hoffmann-La Roche Ltd; German CLL Study Group (GCLLSG); Dana-Farber Cancer Institute
UNKNOWN
AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Moores Cancer Center at UC San Diego /ID# 230157
La Jolla, California, United States
Winship Cancer Institute of Emory University /ID# 230643
Atlanta, Georgia, United States
Des Moines Oncology Research Association /ID# 232606
Des Moines, Iowa, United States
Dana-Farber Cancer Institute /ID# 230061
Boston, Massachusetts, United States
Henry Ford Hospital /ID# 230268
Detroit, Michigan, United States
St. Lukes Hospital of Duluth /ID# 250021
Duluth, Minnesota, United States
Hattiesburg Clinic /ID# 233443
Hattiesburg, Mississippi, United States
Summit Medical Group-Florham Park /ID# 244782
Florham Park, New Jersey, United States
Regional Cancer Care Associates /ID# 244620
Hackensack, New Jersey, United States
University of North Carolina /ID# 233313
Chapel Hill, North Carolina, United States
Novant Health Presbyterian Medical Center /ID# 230201
Charlotte, North Carolina, United States
Novant Health Forsyth Medical Center /ID# 249533
Winston-Salem, North Carolina, United States
Pennsylvania Oncology Hematolo /ID# 249637
Philadelphia, Pennsylvania, United States
University of Wisconsin-Madiso /ID# 232612
Madison, Wisconsin, United States
Royal Adelaide Hospital /ID# 229898
Adelaide, South Australia, Australia
Northern Hospital Epping /ID# 229847
Epping, Victoria, Australia
Peter MacCallum Cancer Ctr /ID# 254634
Melbourne, Victoria, Australia
Universitaetsklinikum St. Poelten /ID# 243493
Sankt Pölten, Lower Austria, Austria
Landeskrankenhaus Hochsteiermark, Standort Leoben /ID# 267569
Leoben, Styria, Austria
Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 249516
Linz, Upper Austria, Austria
Medizinische Universitaet Wien /ID# 230013
Vienna, Vienna, Austria
Klinik Ottakring /ID# 230019
Vienna, Vienna, Austria
Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 230015
Salzburg, , Austria
Hanusch Krankenhaus /ID# 230010
Vienna, , Austria
Hospital de Clinicas de Porto Alegre /ID# 243657
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Nove de Julho /ID# 243658
São Paulo, São Paulo, Brazil
Instituto de Ensino e Pesquisas Sao Lucas /ID# 243659
São Paulo, , Brazil
UMHAT Sveti Georgi EAD /ID# 272321
Plovdiv, , Bulgaria
MHAT Hristo Botev /ID# 229687
Vratsa, , Bulgaria
Stauferklinikum Schwaebisch Gmuend /ID# 230176
Mutlangen, Baden-Wurttemberg, Germany
Universitaetsklinikum Ulm /ID# 230164
Ulm, Baden-Wurttemberg, Germany
VK&K Studien GbR /ID# 230198
Landshut, Bavaria, Germany
Muenchen Klinik Schwabing /ID# 230197
Munich, Bavaria, Germany
Universitaetsmedizin Rostock /ID# 230190
Rostock, Mecklenburg-Vorpommern, Germany
Universitaetsklinikum Koeln /ID# 230296
Cologne, North Rhine-Westphalia, Germany
Universitaetsklinikum des Saarlandes /ID# 248747
Homburg, Saarland, Germany
BAG Freiberg-Richter, Jacobasch, Illmer, Wolf /ID# 230168
Dresden, Saxony, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 230186
Kiel, Schleswig-Holstein, Germany
Onkologische Schwerpunktpraxis /ID# 245465
Berlin, , Germany
Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum /ID# 248748
Berlin, , Germany
Duplicate_DIAKO Ev. Diakonie-Krankenhaus gemeinnuetzige GmbH /ID# 230238
Bremen, , Germany
Universitaetsklinikum Essen /ID# 230181
Essen, , Germany
Universitaetsklinikum Halle (Saale) /ID# 245350
Halle, , Germany
OncoResearch Lerchenfeld GmbH /ID# 230191
Hamburg, , Germany
Klinikum Landshut AdöR der Stadt Landshut /ID# 242991
Landshut, , Germany
Bruederkrankenhaus St. Josef Paderborn /ID# 230177
Paderborn, , Germany
Hadassah /ID# 245059
Jerusalem, Jerusalem, Israel
The Chaim Sheba Medical Center /ID# 243219
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 243218
Tel Aviv, Tel Aviv, Israel
Rabin Medical Center /ID# 243220
Petah Tikva, , Israel
A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 229504
Turin, Piedmont, Italy
Azienda Ospedaliera Santa Maria Terni /ID# 229442
Terni, , Italy
Fundeni Clinical Institute /ID# 241614
Bucharest, București, Romania
Hospital Universitario de la Princesa /ID# 229665
Madrid, , Spain
Blackpool Victoria Hospital /ID# 267280
Blackpool, Lancashire, United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 250733
Norwich, Norfolk, United Kingdom
Leeds Teaching Hospitals NHS Trust /ID# 250732
Leeds, West Yorkshire, United Kingdom
Countries
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Central Contacts
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Related Links
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Related info
Other Identifiers
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2023-504599-10-00
Identifier Type: OTHER
Identifier Source: secondary_id
M20-356
Identifier Type: -
Identifier Source: org_study_id