The primary objective of the study for Cohort 1 and Cohort 2 is to assess the anticancer activity of emavusertib in combination with zanubrutinib in participants with CLL.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Oral tablets
Oral capsules
Mt Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
RECRUITINGMayo Clinic
Rochester, Minnesota, United States
RECRUITINGCohort 1: Undetectable Measurable Residual Disease (uMRD) Rate
Time frame: Up to approximately 23 months
Cohort 2: Overall Response Rate (ORR)
Time frame: Up to approximately 23 months
Cohort 1: Duration of uMRD
Time frame: Up to approximately 23 months
Cohort 1: Time to Measurable Residual Disease (MRD) Conversion
Time frame: Up to approximately 23 months
Cohort 1: Complete Response (CR) Rate
Time frame: Up to approximately 23 months
Cohort 1: Duration of CR
Time frame: Up to approximately 23 months
Cohort 1: Time to CR
Time frame: Up to approximately 23 months
Cohort 2: Duration of Response (DOR)
Time frame: Up to approximately 23 months
Cohort 2: Time to Response
Time frame: Up to approximately 23 months
Cohorts 1 and 2: Progression-free Survival (PFS)
Time frame: Up to approximately 23 months
Cohorts 1 and 2: Overall Survival (OS)
Time frame: Up to approximately 23 months
Cohorts 1 and 2: Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Treatment-related Adverse Events
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Summit Medical Group
Florham Park, New Jersey, United States
RECRUITINGOhio State University Comprehensive Cancer Center
Columbus, Ohio, United States
RECRUITINGUPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
RECRUITINGTexas Oncology - Sammons Cancer Center
Dallas, Texas, United States
RECRUITINGIRCCS Ospedale San Raffaele
Milan, Italy
RECRUITINGAzienda Ospedaliero Universitaria Maggiore Della Carità
Novara, Italy
RECRUITINGAzienda Ospedale Università Padova
Padova, Italy
RECRUITINGMD Anderson Cancer Center Madrid
Madrid, Spain
RECRUITING...and 1 more locations
Time frame: Up to approximately 23 months
Cohorts 1 and 2: Maximum Plasma Concentration (Cmax) of Emavusertib and Zanubrutinib
Time frame: Cycle 1 Day 1 up to Cycle 7 Day 1 (each cycle = 28 days)
Cohorts 1 and 2: Time to Maximum Concentration (Tmax) of Emavusertib and Zanubrutinib
Time frame: Cycle 1 Day 1 up to Cycle 7 Day 1 (each cycle = 28 days)
Cohorts 1 and 2: Area Under the Curve (AUC) from 0 to t Hours (AUC0-t) of Emavusertib and Zanubrutinib
Time frame: Cycle 1 Day 1 up to Cycle 7 Day 1 (each cycle = 28 days)
Cohorts 1 and 2: Trough Plasma Concentration (Cmin) of Emavusertib and Zanubrutinib
Time frame: Cycle 1 Day 1 up to Cycle 7 Day 1 (each cycle = 28 days)