A Randomized, Multicenter, Open-Label, Phase 3 Study to Compare the Efficacy and Safety of Acalabrutinib (ACP-196) in Combination with Venetoclax with and without Obinutuzumab Compared to Investigators Choice of Chemoimmunotherapy in Subjects with Previously Untreated Chronic Lymphocytic Leukemia Without del(17p) or TP53 Mutation
Sponsor: |
Acerta Pharma BV |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAS5165 |
U.S. Govt. ID: |
NCT03836261 |
Contact: |
Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu |
The purpose of this study, which involves research, is to determine if giving an experimental drug called acalabrutinib in combination with venetoclax with and without obinutuzumab is safe and effective for treating people with CLL compared to a combination of bendamustine and rituximab (BR) or a combination of Fludarabine, Cyclophosphamide and Rituximab (FCR).
This study is closed
Investigator
Nicole Lamanna, MD
Are you 18 years of age or older? |
Yes |
No |
Have you been diagnosed with Chronic Lymphocytic Leukemia (CLL)? |
Yes |
No |
Are you able to swallow capsules and tablets without difficulty? |
Yes |
No |