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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,200
Administered orally
Administered orally
Administered orally
USA Mitchell Cancer Institute ( Site 0014)
Mobile, Alabama, United States
RECRUITINGBanner MD Anderson Cancer Center ( Site 0059)
Gilbert, Arizona, United States
RECRUITINGBanner MD Anderson Cancer Center - University Medical Center Phoenix ( Site 0051)
Phoenix, Arizona, United States
RECRUITINGArizona Oncology Associates - NAHOA ( Site 8007)
Prescott, Arizona, United States
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
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Time frame: Up to ~104 months
Duration of Response (DOR) per iwCLL Criteria 2018 as assessed by BICR
For participants who demonstrate a 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, DOR is defined as the time from the first documented evidence of CR, CRi, nPR, or PR that led to response until disease progression or death due to any cause, whichever occurs first.
Time frame: Up to ~104 months
Number of Participants Who Experience One or More Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame: Up to ~104 months
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame: Up to ~104 months
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Alta Bates Summit Medical Center ( Site 0004)
Berkeley, California, United States
ACTIVE_NOT_RECRUITINGMoores Cancer Center ( Site 0003)
La Jolla, California, United States
RECRUITINGCare Access - South Pasadena ( Site 0070)
Pasadena, California, United States
RECRUITINGSaint Joseph Hospital ( Site 0026)
Denver, Colorado, United States
RECRUITINGLutheran Medical Center ( Site 0027)
Golden, Colorado, United States
RECRUITINGIntermountain Health St. Mary's Regional Hospital ( Site 0025)
Grand Junction, Colorado, United States
RECRUITING...and 193 more locations