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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 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Obinutuzumab
- DRUG Venetoclax
Study Locations (20)
North Carolina
- University of North Carolina /ID# 233313 — Chapel Hill
- Novant Health Presbyterian Medical Center /ID# 230201 — Charlotte
- Novant Health Forsyth Medical Center /ID# 249533 — Winston-Salem
New Jersey
- Summit Medical Group-Florham Park /ID# 244782 — Florham Park
- Regional Cancer Care Associates /ID# 244620 — Hackensack
Victoria
- Northern Hospital Epping /ID# 229847 — Epping
- Peter MacCallum Cancer Ctr /ID# 254634 — Melbourne
California
- Moores Cancer Center at UC San Diego /ID# 230157 — La Jolla
Georgia
- Winship Cancer Institute of Emory University /ID# 230643 — Atlanta
Iowa
- Des Moines Oncology Research Association /ID# 232606 — Des Moines
Massachusetts
- Dana-Farber Cancer Institute /ID# 230061 — Boston
Michigan
- Henry Ford Hospital /ID# 230268 — Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2022-03-28 |
| Est. Completion | 2029-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04895436
The ClinicalTrials.gov registry entry for NCT04895436 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Chronic Lymphocytic Leukemia (CLL) appearing as the primary indexed condition, and to 2 interventions — of which Obinutuzumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04895436 reports 20 study locations spanning 16 distinct geographic areas — top geographies include North Carolina, New Jersey, Victoria. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04895436 about?
NCT04895436 is a clinical study titled "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)". 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...
What is the current status of trial NCT04895436?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2022-03-28. Estimated completion is 2029-01.
What conditions does trial NCT04895436 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia (CLL). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04895436?
The interventions under investigation include: Obinutuzumab (DRUG), Venetoclax (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04895436?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04895436 being conducted?
This trial has 20 study locations across California, Georgia, Iowa, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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