Assessing the effects of venetoclax and obinutuzumab in adults with recurring chronic lymphocytic leukemia
A Multicenter, Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of Venetoclax-Obinutuzumab Retreatment in Patients With Recurring Chronic Lymphocytic Leukemia
This study is testing if a combination of two medications, venetoclax and obinutuzumab, can help adults with recurring chronic lymphocytic leukemia feel better after their previous treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Drugs / interventions | obinutuzumab |
| Locations | 58 sites (La Jolla, California and 57 other locations) |
| Trial ID | NCT04895436 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a combination treatment using oral venetoclax and intravenous obinutuzumab in adults with recurring chronic lymphocytic leukemia (CLL) who have previously undergone treatment. Participants will be divided into two cohorts based on the timing of their disease progression after first-line therapy. The treatment will consist of 28-day cycles of venetoclax and obinutuzumab, followed by additional cycles of venetoclax alone. The study aims to monitor changes in disease activity and any adverse events associated with the treatment.
Who should consider this trial
Good fit: Ideal candidates are adults with documented CLL who have previously responded to venetoclax combined with an anti-CD20 antibody and have experienced disease progression after a specified time frame.
Not a fit: Patients who have received intervening treatment for CLL after their initial venetoclax therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with recurring CLL.
How similar studies have performed: Other studies have shown promising results with similar treatment approaches for CLL, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
La Jolla, California and 57 other locations
- Moores Cancer Center at UC San Diego /ID# 230157 — La Jolla, California, United States (Recruiting)
- Winship Cancer Institute of Emory University /ID# 230643 — Atlanta, Georgia, United States (Recruiting)
- Des Moines Oncology Research Association /ID# 232606 — Des Moines, Iowa, United States (Completed)
- Dana-Farber Cancer Institute /ID# 230061 — Boston, Massachusetts, United States (Recruiting)
- Henry Ford Hospital /ID# 230268 — Detroit, Michigan, United States (Completed)
- St. Lukes Hospital of Duluth /ID# 250021 — Duluth, Minnesota, United States (Recruiting)
- Hattiesburg Clinic /ID# 233443 — Hattiesburg, Mississippi, United States (Recruiting)
- Summit Medical Group-Florham Park /ID# 244782 — Florham Park, New Jersey, United States (Completed)
- Regional Cancer Care Associates /ID# 244620 — Hackensack, New Jersey, United States (Recruiting)
- University of North Carolina /ID# 233313 — Chapel Hill, North Carolina, United States (Recruiting)
- Novant Health Presbyterian Medical Center /ID# 230201 — Charlotte, North Carolina, United States (Recruiting)
- Novant Health Forsyth Medical Center /ID# 249533 — Winston-Salem, North Carolina, United States (Recruiting)
- The Ohio State University /ID# 230439 — Columbus, Ohio, United States (Recruiting)
- Pennsylvania Oncology Hematolo /ID# 249637 — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Wisconsin-Madiso /ID# 232612 — Madison, Wisconsin, United States (Completed)
- Royal Adelaide Hospital /ID# 229898 — Adelaide, South Australia, Australia (Recruiting)
- Northern Hospital Epping /ID# 229847 — Epping, Victoria, Australia (Recruiting)
- Peter MacCallum Cancer Ctr /ID# 254634 — Melbourne, Victoria, Australia (Recruiting)
- Universitaetsklinikum St. Poelten /ID# 243493 — Sankt Pölten, Lower Austria, Austria (Recruiting)
- Medizinische Universitaet Wien /ID# 230013 — Vienna, State of Vienna, Austria (Recruiting)
- Klinik Ottakring /ID# 230019 — Vienna, State of Vienna, Austria (Recruiting)
- Landeskrankenhaus Hochsteiermark, Standort Leoben /ID# 267569 — Leoben, Styria, Austria (Recruiting)
- Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 249516 — Linz, Upper Austria, Austria (Recruiting)
- Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 230015 — Salzburg, Austria (Completed)
- Hanusch Krankenhaus /ID# 230010 — Vienna, Austria (Recruiting)
- Hospital de Clinicas de Porto Alegre /ID# 243657 — Porto Alegre, Rio Grande do Sul, Brazil (Completed)
- Hospital Nove de Julho /ID# 243658 — São Paulo, São Paulo, Brazil (Recruiting)
- Instituto de Ensino e Pesquisas Sao Lucas /ID# 243659 — São Paulo, Brazil (Recruiting)
- UMHAT Sveti Georgi EAD /ID# 272321 — Plovdiv, Bulgaria (Recruiting)
- MHAT Hristo Botev /ID# 229687 — Vratsa, Bulgaria (Recruiting)
- Stauferklinikum Schwaebisch Gmuend /ID# 230176 — Mutlangen, Baden-Wurttemberg, Germany (Recruiting)
- Universitaetsklinikum Ulm /ID# 230164 — Ulm, Baden-Wurttemberg, Germany (Recruiting)
- VK&K Studien GbR /ID# 230198 — Landshut, Bavaria, Germany (Recruiting)
- Muenchen Klinik Schwabing /ID# 230197 — Munich, Bavaria, Germany (Completed)
- Universitaetsmedizin Rostock /ID# 230190 — Rostock, Mecklenburg-Vorpommern, Germany (Recruiting)
- Universitaetsklinikum Koeln /ID# 230296 — Cologne, North Rhine-Westphalia, Germany (Recruiting)
- Universitaetsklinikum des Saarlandes /ID# 248747 — Homburg, Saarland, Germany (Recruiting)
- BAG Freiberg-Richter, Jacobasch, Illmer, Wolf /ID# 230168 — Dresden, Saxony, Germany (Recruiting)
- Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 230186 — Kiel, Schleswig-Holstein, Germany (Recruiting)
- Onkologische Schwerpunktpraxis /ID# 245465 — Berlin, Germany (Recruiting)
- Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum /ID# 248748 — Berlin, Germany (Recruiting)
- Duplicate_DIAKO Ev. Diakonie-Krankenhaus gemeinnuetzige GmbH /ID# 230238 — Bremen, Germany (Completed)
- Universitaetsklinikum Essen /ID# 230181 — Essen, Germany (Recruiting)
- Universitaetsklinikum Halle (Saale) /ID# 245350 — Halle, Germany (Recruiting)
- OncoResearch Lerchenfeld GmbH /ID# 230191 — Hamburg, Germany (Recruiting)
- Klinikum Landshut AdöR der Stadt Landshut /ID# 242991 — Landshut, Germany (Recruiting)
- Bruederkrankenhaus St. Josef Paderborn /ID# 230177 — Paderborn, Germany (Recruiting)
- Hadassah /ID# 245059 — Jerusalem, Jerusalem, Israel (Recruiting)
- The Chaim Sheba Medical Center /ID# 243219 — Ramat Gan, Tel Aviv, Israel (Recruiting)
- Tel Aviv Sourasky Medical Center /ID# 243218 — Tel Aviv, Tel Aviv, Israel (Recruiting)
+8 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.