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)

Recruiting now · Phase 2

Conditions studied: Chronic Lymphocytic Leukemia (CLL)

In brief

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.

Key facts

Study ID

NCT04895436

Run by

AbbVie

People needed

75

Starts

2022-03-28

Expected to finish

2029-01-01

Last updated by the study team

2026-02-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Received intervening treatment for CLL after completing previous treatment with a venetoclax + anti-CD20 antibody +/- X regimen.

Where it is running

• Instituto de Ensino e Pesquisas Sao Lucas /ID# 243659 — São Paulo, Brazil (enrolling)
• MHAT Hristo Botev /ID# 229687 — Vratsa, Bulgaria (enrolling)
• Hospital Nove de Julho /ID# 243658 — São Paulo, São Paulo, Brazil (enrolling)
• Winship Cancer Institute of Emory University /ID# 230643 — Atlanta, Georgia, United States (enrolling)
• UMHAT Sveti Georgi EAD /ID# 272321 — Plovdiv, Bulgaria (enrolling)
• Moores Cancer Center at UC San Diego /ID# 230157 — La Jolla, California, United States (enrolling)
• Dana-Farber Cancer Institute /ID# 230061 — Boston, Massachusetts, United States (enrolling)
• Regional Cancer Care Associates /ID# 244620 — Hackensack, New Jersey, United States (enrolling)
• University of North Carolina /ID# 233313 — Chapel Hill, North Carolina, United States (enrolling)
• Novant Health Presbyterian Medical Center /ID# 230201 — Charlotte, North Carolina, United States (enrolling)
• St. Lukes Hospital of Duluth /ID# 250021 — Duluth, Minnesota, United States (enrolling)
• The Ohio State University /ID# 230439 — Columbus, Ohio, United States (enrolling)
• Pennsylvania Oncology Hematolo /ID# 249637 — Philadelphia, Pennsylvania, United States (enrolling)
• Hattiesburg Clinic /ID# 233443 — Hattiesburg, Mississippi, United States (enrolling)
• Royal Adelaide Hospital /ID# 229898 — Adelaide, South Australia, Australia (enrolling)
• Northern Hospital Epping /ID# 229847 — Epping, Victoria, Australia (enrolling)
• Peter MacCallum Cancer Ctr /ID# 254634 — Melbourne, Victoria, Australia (enrolling)
• Universitaetsklinikum St. Poelten /ID# 243493 — Sankt Pölten, Lower Austria, Austria (enrolling)
• Medizinische Universitaet Wien /ID# 230013 — Vienna, State of Vienna, Austria (enrolling)
• Klinik Ottakring /ID# 230019 — Vienna, State of Vienna, Austria (enrolling)
• Landeskrankenhaus Hochsteiermark, Standort Leoben /ID# 267569 — Leoben, Styria, Austria (enrolling)
• Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 249516 — Linz, Upper Austria, Austria (enrolling)
• Novant Health Forsyth Medical Center /ID# 249533 — Winston-Salem, North Carolina, United States (enrolling)
• Hanusch Krankenhaus /ID# 230010 — Vienna, Austria (enrolling)
• Stauferklinikum Schwaebisch Gmuend /ID# 230176 — Mutlangen, Baden-Wurttemberg, Germany (enrolling)

Full record on ClinicalTrials.gov

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