Acalabrutinib Safety Study in Untreated and Relapsed or Refractory Chronic Lymphocytic Leukemia Patients
Public ClinicalTrials.gov record NCT04008706. 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 Phase 3b, Multicenter, Open-Label, Single-Arm Study of Acalabrutinib (ACP-196) in Subjects With Chronic Lymphocytic Leukemia.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a global, Phase IIIb, multicenter, open-label, single-arm study to evaluate the safety and efficacy of acalabrutinib 100 mg twice daily (bid) in approximately 540 participants with chronic lymphocytic leukemia (CLL). Participants will be enrolled into 3 following cohorts: treatment-naive (TN), relapsed/refractory (R/R), and prior ibrutinib therapy. For this study, participants in the UK will be enrolled ONLY into the R/R cohort or the prior ibrutinib cohort. Participants in the US will be enrolled ONLY into the TN or R/R cohort. Participants will remain on study intervention until completion of 48 cycles (28 days per cycle), or until study intervention discontinuation due to, for example disease progression, or toxicity, withdrawal of consent, loss to follow-up, death, or study termination by the sponsor whichever occurs first. The duration of the study will be approximately 72 months from the first participant enrolled. This duration includes an estimated 24-month recruitment time and an assumed 48 cycles of study intervention (28 days per cycle); additional study time will be accrued during the Disease Follow up period for those participants remaining on study intervention after completion of 48 cycles prior to the final data cutoff (DCO) (the amount of time will vary by participant).
Study identification
- NCT ID
- NCT04008706
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 552 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 130 Years
- 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
- Sep 16, 2019
- Primary completion
- Nov 3, 2025
- Completion
- Nov 3, 2025
- Last update posted
- Aug 31, 2026
2019 – 2025
United States locations
- U.S. sites
- 19
- U.S. states
- 12
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Chandler | Arizona | 85224 | — |
| Research Site | Long Beach | California | 90806 | — |
| Research Site | Redlands | California | 92373 | — |
| Research Site | Whittier | California | 90603 | — |
| Research Site | Fort Myers | Florida | 33908 | — |
| Research Site | Jacksonville | Florida | 32256 | — |
| Research Site | St. Petersburg | Florida | 33705 | — |
| Research Site | Marietta | Georgia | 30060 | — |
| Research Site | Normal | Illinois | 61761 | — |
| Research Site | Peoria | Illinois | 61615 | — |
| Research Site | Fort Wayne | Indiana | 46845 | — |
| Research Site | Indianapolis | Indiana | 46260 | — |
| Research Site | Shreveport | Louisiana | 71105 | — |
| Research Site | Saint Cloud | Minnesota | 56303 | — |
| Research Site | Kansas City | Missouri | 64132 | — |
| Research Site | Bethlehem | Pennsylvania | 18015 | — |
| Research Site | Chattanooga | Tennessee | 37404 | — |
| Research Site | Nashville | Tennessee | 37203 | — |
| Research Site | Dallas | Texas | 75235 | — |
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 89 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04008706, 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 Aug 31, 2026 · Synced Sep 18, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04008706 live on ClinicalTrials.gov.