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NCT06428019 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Risk of Tumor Lysis Syndrome (TLS) in Adult Participants Receiving Oral Venetoclax in Combination With Intravenously Infused Obinutuzumab or Oral Acalabrutinib for Previously Untreated Chronic Lymphocytic Leukemia (CLL)
A Phase 3 study of Chronic Lymphocytic Leukemia, sponsored by AbbVie.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 170
- Enrollment target
- 20
- Study locations
NCT06428019: Recruiting Phase 3 study of Chronic Lymphocytic Leukemia, sponsored by AbbVie.
NCT06428019 is a Phase 3 study of Chronic Lymphocytic Leukemia that is actively recruiting participants, run by AbbVie. The registered enrollment target is 170 participants, roughly in line with the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target. The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06428019, a Phase 3 study of Chronic Lymphocytic Leukemia, is actively recruiting participants, sponsored by AbbVie.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 170 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 the safety of venetoclax in combination with obinutuzumab or acalabrutinib in the treatment of CLL. Adverse events and change in disease activity will be assessed. Venetoclax in combination with obinutuzumab or acalabrutinib is being investigated in the treatment of CLL. Study doctors put the participants in 1 of 4 groups, called treatment arms. Participants will receive oral venetoclax in combination with intravenously (IV) infused obinutuzumab or oral acalabrutinib at in different dosing schemes as part of treatment. Approximately 170 adult participants with CLL who are being treated with venetoclax will be enrolled in the study in approximately 80 sites worldwide. Participants in Arm A will receive oral venetoclax in combination with IV infused obinutuzumab, with a 5 week venetoclax ramp up. Participants in Arm B will receive oral venetoclax in combination with oral acalabrutinib, with a 5 week venetoclax ramp up. Participants in Arm C and Arm D will receive oral venetoclax in combination with oral acalabrutinib, with differing venetoclax ramp up periods. The total study duration is approximately 28 months. 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
TLS is defined per Howard criteria that require a clinical intervention per independent review committee (IRC) assessment during the venetoclax ramp-up period in previously untreated participants with chronic lymphocytic leukemia (CLL) achieving a medium tumor burden with creatinine clearance (CrCl) of at least 80 ml/min or low tumor burden (regardless of CrCl level) after debulking therapy.
Conditions Studied
Interventions
- DRUG Obinutuzumab
- DRUG Venetoclax
- DRUG Acalabrutinib
Study Locations (20)
Florida
- Malcolm Randall V.A. Medical Center /ID# 267825 - Gainesville
- Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 266713 - Jacksonville
- Mid Florida Hematology And Oncology Center /ID# 269159 - Orange City
- Comprehensive Hematology Oncology /ID# 267644 - St. Petersburg
Arizona
- Arizona Oncology - Tucson - Rudasill /ID# 267552 - Tucson
- Southern VA Health Care System /ID# 266254 - Tucson
California
- UCSF FRESNO/Community Cancer Institute /ID# 270874 - Clovis
- Valkyrie Clinical Trials /ID# 268151 - Los Angeles
Maryland
- Center for Cancer and Blood Disorders-American Oncology Partners of Maryland /ID# 266445 - Bethesda
- Maryland Oncology Hematology - Silver Spring /ID# 267557 - Silver Spring
Colorado
- Rocky Mountain Cancer Centers - Aurora /ID# 267549 - Aurora
Connecticut
- Yale University School of Medicine /ID# 266224 - New Haven
Illinois
- Springfield Clinic - First /ID# 270145 - Springfield
Indiana
- Northwest Cancer Center - Dyer Clinic /ID# 268478 - Dyer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 170 participants |
| Start Date | 2024-08-05 |
| Est. Completion | 2028-03 |
| Phase | Phase 3 |
What NCT06428019 shows while recruiting
NCT06428019 is an interventional study that assigns participants to a tested intervention. The registered 170 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target.
The record links to 1 condition, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Obinutuzumab is the first listed.
NCT06428019 names 20 study sites across 14 states, led by Florida, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT06428019 about?
NCT06428019 is a clinical study titled "A Study to Evaluate the Risk of Tumor Lysis Syndrome (TLS) in Adult Participants Receiving Oral Venetoclax in Combination With Intravenously Infused Obinutuzumab or Oral Acalabrutinib for Previously Untreated 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 the safety of venetoclax in combination with obinutuzumab or acalabrutinib in the treatment of CLL. Adverse events and change in disease activity will be assessed. Venetocl...
What is the current status of trial NCT06428019?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 170 participants. The study started on 2024-08-05. Estimated completion is 2028-03.
What conditions does trial NCT06428019 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia.
What interventions are being tested in trial NCT06428019?
The interventions under investigation include: Obinutuzumab (DRUG), Venetoclax (DRUG), Acalabrutinib (DRUG).
Who is sponsoring clinical trial NCT06428019?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06428019 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Lymphocytic Leukemia
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 NCT06428019's enrollment target sits among peer trials
170 46th of 187 higher than 142 of 187 other Chronic Lymphocytic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Lymphocytic Leukemia 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
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