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)
Public ClinicalTrials.gov record NCT06428019. 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 Prospective, Open-Label, Phase IIb/III Study to Evaluate the Risk of TLS and Optimization of the Initiation of Venetoclax in Combination With Obinutuzumab or Acalabrutinib With Different Ramp- Up Periods in Previously Untreated Subjects With CLL
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 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.
Study identification
- NCT ID
- NCT06428019
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 170 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
- Aug 4, 2024
- Primary completion
- Feb 29, 2028
- Completion
- Feb 29, 2028
- Last update posted
- Apr 8, 2026
2024 – 2028
United States locations
- U.S. sites
- 32
- U.S. states
- 23
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Oncology - Tucson - Rudasill /ID# 267552 | Tucson | Arizona | 85704 | Recruiting |
| Southern VA Health Care System /ID# 266254 | Tucson | Arizona | 85723 | Recruiting |
| UCSF FRESNO/Community Cancer Institute /ID# 270874 | Clovis | California | 93611 | Recruiting |
| Valkyrie Clinical Trials /ID# 268151 | Los Angeles | California | 90067 | Recruiting |
| Rocky Mountain Cancer Centers - Aurora /ID# 267549 | Aurora | Colorado | 80012 | Recruiting |
| Yale University School of Medicine /ID# 266224 | New Haven | Connecticut | 06510 | Recruiting |
| Malcolm Randall V.A. Medical Center /ID# 267825 | Gainesville | Florida | 32608 | Recruiting |
| Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 266713 | Jacksonville | Florida | 32256 | Recruiting |
| Mid Florida Hematology And Oncology Center /ID# 269159 | Orange City | Florida | 32763 | Recruiting |
| Comprehensive Hematology Oncology /ID# 267644 | St. Petersburg | Florida | 33709 | Recruiting |
| Springfield Clinic - First /ID# 270145 | Springfield | Illinois | 62702 | Recruiting |
| Northwest Cancer Center - Dyer Clinic /ID# 268478 | Dyer | Indiana | 46311 | Recruiting |
| University of Iowa Health Care /ID# 267206 | Des Moines | Iowa | 50314-3017 | Recruiting |
| Willis-Knighton Medical Center /ID# 270569 | Shreveport | Louisiana | 71103 | Completed |
| Center for Cancer and Blood Disorders-American Oncology Partners of Maryland /ID# 266445 | Bethesda | Maryland | 20817 | Recruiting |
| Maryland Oncology Hematology - Silver Spring /ID# 267557 | Silver Spring | Maryland | 20904 | Recruiting |
| UMass Memorial Medical Center /ID# 270023 | Worcester | Massachusetts | 01655 | Recruiting |
| Henry Ford Hospital /ID# 270973 | Detroit | Michigan | 48202 | Recruiting |
| Saint Lukes Hospital of Kansas City /ID# 267270 | Kansas City | Missouri | 64111 | Recruiting |
| Icahn School of Medicine at Mount Sinai /ID# 266328 | New York | New York | 10029 | Recruiting |
| Atrium Health /ID# 267219 | Charlotte | North Carolina | 28204-2963 | Recruiting |
| Atrium Health Wake Forest Baptist Medical Center /ID# 273142 | Winston-Salem | North Carolina | 27157 | Recruiting |
| Cleveland Clinic Main Campus /ID# 271292 | Cleveland | Ohio | 44195 | Recruiting |
| Oklahoma Cancer Specialists and Research Institute /ID# 267643 | Tulsa | Oklahoma | 74146 | Recruiting |
| Willamette Valley Cancer Institute and Research Center /ID# 266326 | Eugene | Oregon | 97401 | Recruiting |
| Lifespan Cancer Institute - Providence /ID# 266550 | Providence | Rhode Island | 02903 | Recruiting |
| Texas Oncology - Austin Midtown /ID# 268152 | Austin | Texas | 78705 | Recruiting |
| University of Texas - Southwestern Medical Center /ID# 266528 | Dallas | Texas | 75235 | Recruiting |
| Virginia Cancer Specialists - Fairfax /ID# 268155 | Fairfax | Virginia | 22031 | Recruiting |
| Vista Oncology - East Olympia /ID# 267337 | Olympia | Washington | 98506 | Recruiting |
| Northwest Medical Specialties Tacoma /ID# 266327 | Tacoma | Washington | 98405 | Recruiting |
| West Virginia University School of Medicine /ID# 267645 | Morgantown | West Virginia | 26506 | Recruiting |
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 38 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06428019, 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 Apr 8, 2026 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06428019 live on ClinicalTrials.gov.