A Phase 3, Randomized Study to Compare Nemtabrutinib Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in Participants With Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BELLWAVE-011)
Summary
The goal of this study is to evaluate nemtabrutinib compared with investigator's choice of ibrutinib or acalabrutinib in participants with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have not received any prior therapy. The primary hypotheses are that (1) nemtabrutinib is non-inferior to ibrutinib or acalabrutinib with respect to objective response rate (ORR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 by blinded independent central review (BICR) and (2) nemtabrutinib is superior to ibrutinib or acalabrutinib with respect to progression free survival (PFS) per iwCLL Criteria 2018 by BICR.
Arms & interventions
- DrugNemtabrutinib
Administered orally
- DrugIbrutinib
Administered orally
- DrugAcalabrutinib
Administered orally
Outcome measures
Primary
Objective Response Rate (ORR) per Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 as assessed by Blinded Independent Central Review (BICR)
ORR is defined as the percentage of participants with complete response (CR), complete response with an incomplete recovery of the participant's bone marrow (CRi), nodular partial response (nPR), or partial response (PR), per iwCLL Criteria 2018 as assessed by BICR.
Time frame: Up to ~33 months
Progression-Free Survival (PFS) per iwCLL Criteria 2018 as assessed by BICR
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. PD is evaluated per iwCLL Criteria 2018 as assessed by BICR.
Time frame: Up to ~104 months
Secondary
Overall Survival (OS)
Time frame: Up to ~104 months
Duration of Response (DOR) per iwCLL Criteria 2018 as assessed by BICR
Time frame: Up to ~104 months
Number of Participants Who Experience One or More Adverse Events (AEs)
Time frame: Up to ~104 months
Number of Participants Who Discontinue Study Treatment Due to an AE
Time frame: Up to ~104 months
Eligibility criteria
Study locations (43)
USA Mitchell Cancer Institute ( Site 0014)
Mobile, Alabama, 36604
Banner MD Anderson Cancer Center ( Site 0059)
Gilbert, Arizona, 85234
Banner MD Anderson Cancer Center - University Medical Center Phoenix ( Site 0051)
Phoenix, Arizona, 85006
Arizona Oncology Associates - NAHOA ( Site 8007)
Prescott, Arizona, 86301
Alta Bates Summit Medical Center ( Site 0004)
Berkeley, California, 94704
Moores Cancer Center ( Site 0003)
La Jolla, California, 92093-0698
Care Access - South Pasadena ( Site 0070)
Pasadena, California, 91105
Saint Joseph Hospital ( Site 0026)
Denver, Colorado, 80218
Lutheran Medical Center ( Site 0027)
Golden, Colorado, 80401
Intermountain Health St. Mary's Regional Hospital ( Site 0025)
Grand Junction, Colorado, 81501
Eastern CT Hematology & Oncology Associates ( Site 0033)
Norwich, Connecticut, 06360
Clermont Oncology Center ( Site 0046)
Clermont, Florida, 34711
Florida Cancer Specialists - South ( Site 7001)
Fort Myers, Florida, 33901
Florida Cancer Specialists - East ( Site 7002)
West Palm Beach, Florida, 33401
Parkview Research Center at Parkview Regional Medical Center ( Site 0002)
Fort Wayne, Indiana, 46845
University of Iowa Health Care. ( Site 0017)
Waukee, Iowa, 50263
University of Iowa Health Care. ( Site 0057)
Waukee, Iowa, 50263
Saint Elizabeth Healthcare ( Site 0041)
Edgewood, Kentucky, 41017
Corewell Health-Lemmon Holton Cancer Pavilion ( Site 0011)
Grand Rapids, Michigan, 49503
Regions Hospital ( Site 0042)
Saint Louis Park, Minnesota, 55416
MidAmerica Cancer Care, LLC ( Site 0043)
Kansas City, Missouri, 64132
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0052)
Billings, Montana, 59102
Summit Medical Group Cancer Center ( Site 0007)
Florham Park, New Jersey, 07932
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0016)
Hackensack, New Jersey, 07601
New York Oncology Hematology, P.C. ( Site 0069)
Albany, New York, 12208
Roswell Park Cancer Institute ( Site 0023)
Buffalo, New York, 14263
RPCI Oncology, PC- Northtowns ( Site 0061)
Williamsville, New York, 14221
Carolina Oncology Specialists, PA ( Site 0054)
Charlotte, North Carolina, 28207
Southeastern Medical Oncology Center ( Site 0049)
Goldsboro, North Carolina, 27534
Consultants in Medical Oncology and Hematology (CMOH) ( Site 8002)
Broomall, Pennsylvania, 19008
Cancer Care Associates Of York ( Site 0005)
York, Pennsylvania, 17403
Tennessee Oncology-Chattanooga ( Site 0045)
Chattanooga, Tennessee, 37404
Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology ( Site 0031)
Nashville, Tennessee, 37203
Texas Oncology - Central/South Texas ( Site 8008)
Austin, Texas, 78705
The Center for Cancer and Blood Disorders ( Site 0032)
Fort Worth, Texas, 76104
Texas Oncology - San Antonio ( Site 8006)
San Antonio, Texas, 78217
Texas Oncology - Northeast Texas ( Site 8012)
Tyler, Texas, 75702
University of Virginia Cancer Center ( Site 0040)
Charlottesville, Virginia, 22903
Inova Schar Cancer Institute ( Site 0015)
Fairfax, Virginia, 22031
Virginia Commonwealth University (VCU) Medical Center ( Site 0030)
Richmond, Virginia, 23298
Medical Oncology Associates, PS (dba Summit Cancer Centers) ( Site 0010)
Spokane, Washington, 99208
SSM Health Dean Medical Group - South Madison Campus Health Research/Circuit Clinical ( Site 0048)
Madison, Wisconsin, 53715
University Hospital and UW Health Clinics ( Site 0006)
Madison, Wisconsin, 53792