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NCT04895436 · ClinicalTrials.gov registry record · Phase 2
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)
A Phase 2 study of Chronic Lymphocytic Leukemia (CLL), sponsored by AbbVie.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 75
- Enrollment target
- 20
- Study locations
NCT04895436: Recruiting Phase 2 study of Chronic Lymphocytic Leukemia (CLL), sponsored by AbbVie.
NCT04895436 is a Phase 2 study of Chronic Lymphocytic Leukemia (CLL) that is actively recruiting participants, run by AbbVie. The registered enrollment target is 75 participants, below the 189-participant average among 29 other Chronic Lymphocytic Leukemia (CLL) trials with a reported enrollment target (60% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04895436, a Phase 2 study of Chronic Lymphocytic Leukemia (CLL), is actively recruiting participants, sponsored by AbbVie.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 75 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
OR is defined as the percentage of participants achieving a best response of partial remission (PR), nodular partial remission (nPR), complete remission with incomplete marrow recovery (CRi), or complete remission (CR). Disease assessments will be based on the 2018 International Workshop for Chronic Lymphocytic Leukemia (iwCLL) criteria for tumor response.
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 |
What NCT04895436 shows while recruiting
NCT04895436 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 189-participant average among 29 other Chronic Lymphocytic Leukemia (CLL) trials with a reported enrollment target (60% lower).
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.
NCT04895436 names 20 study sites across 16 states, led by North Carolina, New Jersey, Victoria.
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).
What interventions are being tested in trial NCT04895436?
The interventions under investigation include: Obinutuzumab (DRUG), Venetoclax (DRUG).
Who is sponsoring clinical trial NCT04895436?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Chronic Lymphocytic Leukemia (CLL)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04895436's enrollment target sits among peer trials
75 16th of 29 higher than 14 of 29 other Chronic Lymphocytic Leukemia (CLL) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Lymphocytic Leukemia (CLL) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Study of Zanubrutinib, Obinutuzumab, and Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL)
RECRUITING · Phase 2
-
A Study of NX-5948 in Adults With CLL/SLL Previously Treated With a Bruton's Tyrosine Kinase Inhibitor and a B-cell Lymphoma-2 Inhibitor (DAYBreak CLL-201)
RECRUITING · Phase 2
-
Zanubrutinib and Venetoclax in CLL (ZANU-VEN)
RECRUITING · Phase 2
-
The Combination of Venetoclax and Obinutuzumab in People With Chronic Lymphocytic Leukemia (CLL)
ACTIVE NOT RECRUITING · Phase 2
-
Assessing Minimal Residual Disease by Next- Generation Sequencing to Minimize Exposure in People With CLL or SLL Who Have Been Treated With Venetoclax
ACTIVE NOT RECRUITING · Phase 2
-
Acalabrutinib, Venetoclax, and Obinutuzumab for Initial Therapy of CLL
ACTIVE NOT RECRUITING · Phase 2
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