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)
Public ClinicalTrials.gov record NCT04895436. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04895436
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 75 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 27, 2022
- Primary completion
- Oct 31, 2026
- Completion
- Dec 31, 2028
- Last update posted
- Feb 8, 2026
2022 – 2029
United States locations
- U.S. sites
- 15
- U.S. states
- 12
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Moores Cancer Center at UC San Diego /ID# 230157 | La Jolla | California | 92093 | Recruiting |
| Winship Cancer Institute of Emory University /ID# 230643 | Atlanta | Georgia | 30322 | Recruiting |
| Des Moines Oncology Research Association /ID# 232606 | Des Moines | Iowa | 50309-1423 | Completed |
| Dana-Farber Cancer Institute /ID# 230061 | Boston | Massachusetts | 02215 | Recruiting |
| Henry Ford Hospital /ID# 230268 | Detroit | Michigan | 48202 | Completed |
| St. Lukes Hospital of Duluth /ID# 250021 | Duluth | Minnesota | 55805 | Recruiting |
| Hattiesburg Clinic /ID# 233443 | Hattiesburg | Mississippi | 39401 | Recruiting |
| Summit Medical Group-Florham Park /ID# 244782 | Florham Park | New Jersey | 07932-1049 | Completed |
| Regional Cancer Care Associates /ID# 244620 | Hackensack | New Jersey | 07601-7015 | Recruiting |
| University of North Carolina /ID# 233313 | Chapel Hill | North Carolina | 27514 | Recruiting |
| Novant Health Presbyterian Medical Center /ID# 230201 | Charlotte | North Carolina | 28204 | Recruiting |
| Novant Health Forsyth Medical Center /ID# 249533 | Winston-Salem | North Carolina | 27103 | Recruiting |
| The Ohio State University /ID# 230439 | Columbus | Ohio | 43210 | Recruiting |
| Pennsylvania Oncology Hematolo /ID# 249637 | Philadelphia | Pennsylvania | 19106 | Recruiting |
| University of Wisconsin-Madiso /ID# 232612 | Madison | Wisconsin | 53705 | Completed |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 43 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04895436, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 8, 2026 · Synced Sep 6, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04895436 live on ClinicalTrials.gov.