Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL
Condition(s) studied
Investigational drug(s) / intervention(s)
Acalabrutinib: Acalabrutinib,
Venetoclax: Venetoclax
Chemoimmunotherapy: fludarabine/cyclophosphamide/rituximab (FCR), bendamustine/rituximab (BR)
Obinutuzumab: Obinutuzumab
Study summary
The purpose of this study is to evaluate the efficacy and safety of acalabrutinib in combination with venetoclax and acalabrutinib in combination with venetoclax with and without obinutuzumab compared to chemoimmunotherapy in subjects with previously untreated CLL
Eligibility
Primary outcome measure(s)
- To evaluate the efficacy of acalabrutinib with venetoclax (Arm A) compared to chemoimmunotherapy fludarabine/cyclophosphamide/rituximab [FCR] or bendamustine/rituximab [BR] (Arm C): PFS — 6 years
Progression-free survival (PFS) after randomization, defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the Independent Review Committee (IRC) according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2018 criteria
Trial sites (170)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Los Angeles | California | |
| Research Site | Redondo Beach | California | |
| Research Site | Fort Wayne | Indiana | |
| Research Site | Wichita | Kansas | |
| Research Site | Louisville | Kentucky | |
| Research Site | New Orleans | Louisiana | |
| Research Site | Baltimore | Maryland | |
| Research Site | Boston | Massachusetts | |
| Research Site | New York | New York | |
| Research Site | Charlotte | North Carolina | |
| Research Site | Canton | Ohio | |
| Research Site | Pittsburgh | Pennsylvania | |
| Research Site | Pittsburgh | Pennsylvania | |
| Research Site | Fort Sam Houston | Texas | |
| Research Site | Spokane | Washington | |
| Research Site | Tacoma | Washington | |
| Research Site | Buenos Aires | Argentina | |
| Research Site | Buenos Aires | Argentina | |
| Research Site | Capital Federal | Argentina | |
| Research Site | Córdoba | Argentina | |
| Research Site | Adelaide | Australia | |
| Research Site | Darlinghurst | Australia | |
| Research Site | Heidelberg | Australia | |
| Research Site | Kogarah | Australia | |
| Research Site | Melbourne | Australia | |
| Research Site | Nedlands | Australia | |
| Research Site | Waratah | Australia | |
| Research Site | Woolloongabba | Australia | |
| Research Site | Krems | Austria | |
| Research Site | Salzburg | Austria | |
| Research Site | Vienna | Austria | |
| Research Site | Goiânia | Brazil | |
| Research Site | Porto Alegre | Brazil | |
| Research Site | Porto Alegre | Brazil | |
| Research Site | Porto Alegre | Brazil | |
| Research Site | Rio de Janeiro | Brazil | |
| Research Site | Rio de Janeiro | Brazil | |
| Research Site | São Paulo | Brazil | |
| Research Site | São Paulo | Brazil | |
| Research Site | São Paulo | Brazil |
+ 130 more sites — see the full list on the official registry below.
More Acerta Pharma BV trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03836261 on ClinicalTrials.gov ↗ ← All trials in Italy