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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)

NCT04895436 · AbbVie
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Official title
A Multicenter, Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of Venetoclax-Obinutuzumab Retreatment in Patients With Recurring Chronic Lymphocytic Leukemia
About this study
Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess retreatment with venetoclax-obinutuzumab (VenG) in participants previously treated with fixed duration first-line (IL) therapy of venetoclax in combination with an anti-CD20 antibody +/- X (where X is any additional drug). Adverse events and change in disease activity will be assessed. 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.
Eligibility criteria
Inclusion Criteria: * Documented diagnosis of chronic lymphocytic leukemia (CLL) that requires treatment for CLL according to International Workshop for Chronic Lymphocytic Leukemia (iwCLL) 2018 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: \- Received intervening treatment for CLL after completing previous treatment with a venetoclax + anti-CD20 antibody +/- X regimen.
Study design
Enrollment target: 75 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-03-28
Estimated completion: 2029-01
Last updated: 2026-02-09
Interventions
Drug: VenetoclaxDrug: Obinutuzumab
Primary outcomes
  • Overall response (OR) in Cohort 1 after end of combination treatment (9 months)
Sponsor
AbbVie · industry
With: F. Hoffmann-La Roche Ltd; German CLL Study Group (GCLLSG); Dana-Farber Cancer Institute
Contacts & investigators
ContactABBVIE CALL CENTER · contact · abbvieclinicaltrials@abbvie.com · 844-663-3742
InvestigatorABBVIE INC. · study_director, AbbVie
All locations (58)
Moores Cancer Center at UC San Diego /ID# 230157Recruiting
La Jolla, California, United States
Winship Cancer Institute of Emory University /ID# 230643Recruiting
Atlanta, Georgia, United States
Des Moines Oncology Research Association /ID# 232606Completed
Des Moines, Iowa, United States
Dana-Farber Cancer Institute /ID# 230061Recruiting
Boston, Massachusetts, United States
Henry Ford Hospital /ID# 230268Completed
Detroit, Michigan, United States
St. Lukes Hospital of Duluth /ID# 250021Recruiting
Duluth, Minnesota, United States
Hattiesburg Clinic /ID# 233443Recruiting
Hattiesburg, Mississippi, United States
Summit Medical Group-Florham Park /ID# 244782Completed
Florham Park, New Jersey, United States
Regional Cancer Care Associates /ID# 244620Recruiting
Hackensack, New Jersey, United States
University of North Carolina /ID# 233313Recruiting
Chapel Hill, North Carolina, United States
Novant Health Presbyterian Medical Center /ID# 230201Recruiting
Charlotte, North Carolina, United States
Novant Health Forsyth Medical Center /ID# 249533Recruiting
Winston-Salem, North Carolina, United States
The Ohio State University /ID# 230439Recruiting
Columbus, Ohio, United States
Pennsylvania Oncology Hematolo /ID# 249637Recruiting
Philadelphia, Pennsylvania, United States
University of Wisconsin-Madiso /ID# 232612Completed
Madison, Wisconsin, United States
Royal Adelaide Hospital /ID# 229898Recruiting
Adelaide, South Australia, Australia
Northern Hospital Epping /ID# 229847Recruiting
Epping, Victoria, Australia
Peter MacCallum Cancer Ctr /ID# 254634Recruiting
Melbourne, Victoria, Australia
Universitaetsklinikum St. Poelten /ID# 243493Recruiting
Sankt Pölten, Lower Austria, Austria
Medizinische Universitaet Wien /ID# 230013Recruiting
Vienna, State of Vienna, Austria
Klinik Ottakring /ID# 230019Recruiting
Vienna, State of Vienna, Austria
Landeskrankenhaus Hochsteiermark, Standort Leoben /ID# 267569Recruiting
Leoben, Styria, Austria
Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 249516Recruiting
Linz, Upper Austria, Austria
Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 230015Completed
Salzburg, Austria
Hanusch Krankenhaus /ID# 230010Recruiting
Vienna, Austria
Hospital de Clinicas de Porto Alegre /ID# 243657Completed
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Nove de Julho /ID# 243658Recruiting
São Paulo, São Paulo, Brazil
Instituto de Ensino e Pesquisas Sao Lucas /ID# 243659Recruiting
São Paulo, Brazil
UMHAT Sveti Georgi EAD /ID# 272321Recruiting
Plovdiv, Bulgaria
MHAT Hristo Botev /ID# 229687Recruiting
Vratsa, Bulgaria
Stauferklinikum Schwaebisch Gmuend /ID# 230176Recruiting
Mutlangen, Baden-Wurttemberg, Germany
Universitaetsklinikum Ulm /ID# 230164Recruiting
Ulm, Baden-Wurttemberg, Germany
VK&K Studien GbR /ID# 230198Recruiting
Landshut, Bavaria, Germany
Muenchen Klinik Schwabing /ID# 230197Completed
Munich, Bavaria, Germany
Universitaetsmedizin Rostock /ID# 230190Recruiting
Rostock, Mecklenburg-Vorpommern, Germany
Universitaetsklinikum Koeln /ID# 230296Recruiting
Cologne, North Rhine-Westphalia, Germany
Universitaetsklinikum des Saarlandes /ID# 248747Recruiting
Homburg, Saarland, Germany
BAG Freiberg-Richter, Jacobasch, Illmer, Wolf /ID# 230168Recruiting
Dresden, Saxony, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 230186Recruiting
Kiel, Schleswig-Holstein, Germany
Onkologische Schwerpunktpraxis /ID# 245465Recruiting
Berlin, Germany
Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum /ID# 248748Recruiting
Berlin, Germany
Duplicate_DIAKO Ev. Diakonie-Krankenhaus gemeinnuetzige GmbH /ID# 230238Completed
Bremen, Germany
Universitaetsklinikum Essen /ID# 230181Recruiting
Essen, Germany
Universitaetsklinikum Halle (Saale) /ID# 245350Recruiting
Halle, Germany
OncoResearch Lerchenfeld GmbH /ID# 230191Recruiting
Hamburg, Germany
Klinikum Landshut AdöR der Stadt Landshut /ID# 242991Recruiting
Landshut, Germany
Bruederkrankenhaus St. Josef Paderborn /ID# 230177Recruiting
Paderborn, Germany
Hadassah /ID# 245059Recruiting
Jerusalem, Jerusalem, Israel
The Chaim Sheba Medical Center /ID# 243219Recruiting
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 243218Recruiting
Tel Aviv, Tel Aviv, Israel
Rabin Medical Center. /ID# 243220Recruiting
Petah Tikva, Israel
A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 229504Recruiting
Turin, Piedmont, Italy
Azienda Ospedaliera Santa Maria Terni /ID# 229442Recruiting
Terni, Italy
Fundeni Clinical Institute /ID# 241614Recruiting
Bucharest, Bucharest, Romania
Hospital Universitario de la Princesa /ID# 229665Recruiting
Madrid, Spain
Blackpool Victoria Hospital /ID# 267280Recruiting
Blackpool, Lancashire, United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 250733Recruiting
Norwich, Norfolk, United Kingdom
Leeds Teaching Hospitals NHS Trust /ID# 250732Recruiting
Leeds, West Yorkshire, United Kingdom
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) · TrialPath