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)
A Multicenter, Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of Venetoclax-Obinutuzumab Retreatment in Patients With Recurring Chronic Lymphocytic Leukemia
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Moores Cancer Center at UC San Diego /ID# 230157 — La Jolla, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (58 Sites)
Showing the first 25 of 58 sites.
- Moores Cancer Center at UC San Diego /ID# 230157 — La Jolla, California
- Winship Cancer Institute of Emory University /ID# 230643 — Atlanta, Georgia
- Des Moines Oncology Research Association /ID# 232606 — Des Moines, Iowa
- Dana-Farber Cancer Institute /ID# 230061 — Boston, Massachusetts
- Henry Ford Hospital /ID# 230268 — Detroit, Michigan
- St. Lukes Hospital of Duluth /ID# 250021 — Duluth, Minnesota
- Hattiesburg Clinic /ID# 233443 — Hattiesburg, Mississippi
- Summit Medical Group-Florham Park /ID# 244782 — Florham Park, New Jersey
- Regional Cancer Care Associates /ID# 244620 — Hackensack, New Jersey
- University of North Carolina /ID# 233313 — Chapel Hill, North Carolina
- Novant Health Presbyterian Medical Center /ID# 230201 — Charlotte, North Carolina
- Novant Health Forsyth Medical Center /ID# 249533 — Winston-Salem, North Carolina
- The Ohio State University /ID# 230439 — Columbus, Ohio
- Pennsylvania Oncology Hematolo /ID# 249637 — Philadelphia, Pennsylvania
- University of Wisconsin-Madiso /ID# 232612 — Madison, Wisconsin
- Royal Adelaide Hospital /ID# 229898 — Adelaide, South Australia
- Northern Hospital Epping /ID# 229847 — Epping, Victoria
- Peter MacCallum Cancer Ctr /ID# 254634 — Melbourne, Victoria
- Universitaetsklinikum St. Poelten /ID# 243493 — Sankt Pölten, Lower Austria
- Medizinische Universitaet Wien /ID# 230013 — Vienna, State of Vienna
- Klinik Ottakring /ID# 230019 — Vienna, State of Vienna
- Landeskrankenhaus Hochsteiermark, Standort Leoben /ID# 267569 — Leoben, Styria
- Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 249516 — Linz, Upper Austria
- Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 230015 — Salzburg,
- Hanusch Krankenhaus /ID# 230010 — Vienna,
📞 Contact the Study Coordinator
Phone: (844) 663-3742
Email: abbvieclinicaltrials@abbvie.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Chronic Lymphocytic Leukemia (CLL)
- The Combination of Venetoclax and Obinutuzumab in People With Chronic Lymphocytic Leukemia (CLL) — Stanford, California
- Assessing Minimal Residual Disease by Next- Generation Sequencing to Minimize Exposure in People With CLL or SLL Who Have Been Treated With Venetoclax — Basking Ridge, New Jersey
- A Trial of "Armored" CAR T Cells Targeting CD19 For Patients With Relapsed CD19+ Hematologic Malignancies — New York, New York
- Acalabrutinib, Venetoclax, and Obinutuzumab for Initial Therapy of CLL — Stamford, Connecticut
- A Phase 2 Trial Of The Bruton Tyrosine Kinase Degrader BGB-16673 In Combination With BCL-2 Inhibitor Sonrotoclax For Patients With Treatment-Naive Chronic Lymphocytic Leukemia (CLL) — Houston, Texas
- Immune Profiling of CLL/SLL Treated With First-Line Pirtobrutinib — Bethesda, Maryland
Explore by condition: All Chronic Lymphocytic Leukemia (CLL) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.