Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment naïve CLL
Public ClinicalTrials.gov record NCT02475681. 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 Randomized, Multicenter, Open-Label, 3 Arm Phase 3 Study of Obinutuzumab in Combination With Chlorambucil, Acalabrutinib (ACP-196) in Combination With Obinutuzumab, and Acalabrutinib Monotherapy in Subjects With Previously Untreated CLL
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This Primary objective is evaluating the efficacy of obinutuzumab in combination with chlorambucil (Arm A) compared with acalabrutinib in combination with obinutuzumab (Arm B) for the treatment of previously untreated chronic lymphocytic leukemia (CLL). Secondary objectives: 1) To evaluate the efficacy of obinutuzumab in combination with chlorambucil (Arm A) versus acalabrutinib monotherapy (Arm C) based on IRC assessment of PFS per IWCLL 2008 criteria. 2)To compare obinutuzumab plus chlorambucil (Arm A) versus acalabrutinib plus obinutuzumab (Arm B) and obinutuzumab plus chlorambucil (Arm A) versus acalabrutinib monotherapy (Arm C) in terms of: IRC-assessed objective response rate (ORR); Tine to next treatment (TTNT); Overall Survival (OS)
Study identification
- NCT ID
- NCT02475681
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 535 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
- Jun 25, 2015
- Primary completion
- Feb 7, 2019
- Completion
- Sep 14, 2026
- Last update posted
- Aug 24, 2026
2015 – 2026
United States locations
- U.S. sites
- 51
- U.S. states
- 22
- U.S. cities
- 47
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Goodyear | Arizona | 85395 | — |
| Research Site | Phoenix | Arizona | 85016 | — |
| Research Site | Anaheim | California | 92801 | — |
| Research Site | Los Angeles | California | 90017 | — |
| Research Site | Los Angeles | California | 90033 | — |
| Research Site | Los Angeles | California | 90095 | — |
| Research Site | Oxnard | California | 93030 | — |
| Research Site | Palo Alto | California | 94304 | — |
| Research Site | Aurora | Colorado | 80045 | — |
| Research Site | Lone Tree | Colorado | 80124 | — |
| Research Site | Washington D.C. | District of Columbia | 20007 | — |
| Research Site | Fort Myers | Florida | 33901-8101 | — |
| Research Site | Jacksonville | Florida | 32224 | — |
| Research Site | Tallahassee | Florida | 32308-5304 | — |
| Research Site | Tallahassee | Florida | 32308 | — |
| Research Site | Tampa | Florida | 33612 | — |
| Research Site | Niles | Illinois | 60714 | — |
| Research Site | Lafayette | Indiana | 47904 | — |
| Research Site | Wichita | Kansas | 67214 | — |
| Research Site | Louisville | Kentucky | 40207 | — |
| Research Site | New Orleans | Louisiana | 70112 | — |
| Research Site | COL | Maryland | 21044 | — |
| Research Site | Rochester | Minnesota | 55905 | — |
| Research Site | Saint Cloud | Minnesota | 56303 | — |
| Research Site | Billings | Montana | 59102 | — |
| Research Site | Brick | New Jersey | 08724 | — |
| Research Site | Hackensack | New Jersey | ?07601 | — |
| Research Site | Lake Success | New York | 11042 | — |
| Research Site | New York | New York | 10029 | — |
| Research Site | Blue Ash | Ohio | 45242 | — |
| Research Site | Canton | Ohio | 44719 | — |
| Research Site | Columbus | Ohio | 43210 | — |
| Research Site | Nashville | Tennessee | 37203 | — |
| Research Site | Austin | Texas | 78705 | — |
| Research Site | Bedford | Texas | 76022 | — |
| Research Site | Dallas | Texas | 75230 | — |
| Research Site | Fort Sam Houston | Texas | 78234 | — |
| Research Site | Houston | Texas | 77030 | — |
| Research Site | New Braunfels | Texas | 78130 | — |
| Research Site | Round Rock | Texas | 76508 | — |
| Research Site | San Antonio | Texas | 78258 | — |
| Research Site | Texas City | Texas | 77591 | — |
| Research Site | Tyler | Texas | 75702 | — |
| Research Site | Salt Lake City | Utah | 84112 | — |
| Research Site | Roanoke | Virginia | 24014 | — |
| Research Site | Seattle | Washington | 98109 | — |
| Research Site | Seattle | Washington | 98122 | — |
| Research Site | Spokane | Washington | 99208 | — |
| Research Site | Tacoma | Washington | 98405 | — |
| Research Site | Yakima | Washington | 98902 | — |
| Research Site | Northwest WA | Wisconsin | 20007 | — |
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 104 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02475681, 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 24, 2026 · Synced Sep 17, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02475681 live on ClinicalTrials.gov.