Assessing the effects of venetoclax and obinutuzumab in adults with recurring chronic lymphocytic leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Dana-Farber Cancer Institute /ID# 230061
  Boston, Massachusetts, United States Recruiting
• St. Lukes Hospital of Duluth /ID# 250021
  Duluth, Minnesota, United States Recruiting
• Hattiesburg Clinic /ID# 233443
  Hattiesburg, Mississippi, United States Recruiting
• Regional Cancer Care Associates /ID# 244620
  Hackensack, New Jersey, United States 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Acalabrutinib and Venetoclax for relapsed CLL/SLL after initial BTKi+BCL2i response

  This trial tests a finite-duration combination of acalabrutinib and venetoclax in adults whose CLL or SLL has relapsed after a first-line BTKi+BCL2i therapy and who had at least 2 years of response.

  Recruiting at 16 sites Phase 2 AstraZeneca · Boston, Massachusetts and 46 other locations · NCT07024706

• Ibrutinib and Venetoclax in CLL/SLL: Long-Term Outcomes After Frontline CAPTIVATE

  This study follows people with CLL or SLL who previously received the ibrutinib plus venetoclax combination in CAPTIVATE to see how they do over time and what treatments they need if the disease returns.

  Recruiting European Research Initiative on CLL · Milan · NCT07774390

• Obinutuzumab beta with low-dose steroids in new-onset ANCA-associated glomerulonephritis

  This study tests whether adding Obinutuzumab beta to a rapid-tapering glucocorticoid plan can help people with new-onset ANCA-associated glomerulonephritis see if they achieve remission.

  Recruiting Phase 2 Chinese PLA General Hospital · Beijing · NCT07746180

• Orelabrutinib with Obinutuzumab and Short-Course Venetoclax in Treatment-Naïve Mantle Cell Lymphoma

  This trial tests whether a combo of orelabrutinib, obinutuzumab, and a short course of venetoclax is safe and effective for adults with newly diagnosed mantle cell lymphoma.

  Recruiting at 2 sites Phase 2 The First Affiliated Hospital with Nanjing Medical University · Changzhou, Jiangsu and 1 other locations · NCT07719556

• Obinutuzumab vs steroids for adults with minimal change disease

  This study tests whether obinutuzumab can induce remission in adults with minimal change disease and whether it reduces relapses compared with glucocorticoids.

  Recruiting at 2 sites Phase 2 Medical University Innsbruck · Graz and 5 other locations · NCT07710157

• Impact of Targeted Therapy on Cancer-Related Cognitive Impairment

  This study checks whether brain health and well‑being differ for people with leukemia who are starting or on TKI therapy compared with similar individuals without cancer or TKI exposure.

  Recruiting University of Rochester · Rochester, New York · NCT07638007

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.