Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Conditions
Brief summary
Researchers are looking for new ways to treat people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). CLL and SLL are types of blood cancer. Researchers want to know if people who take nemtabrutinib compared to those who take the standard treatments in this study will live longer without their cancer growing, spreading or returning (progression free survival).
Interventions
DRUGNemtabrutinib
65 mg administered orally daily until disease progression, unacceptable toxicity, or discontinuation criteria met.
DRUGFludarabine
25 mg/m\^2 administered via intravenous (IV) infusion on Days 1, 2, and 3 of each 28-day cycle up to 6 cycles.
DRUGCyclophosphamide
250 mg/m\^2 administered via IV infusion on Days 1, 2, and 3 of each 28-day cycle up to 6 cycles.
DRUGBendamustine
Administered via IV infusion on Days 1 and 2 of each 28-day cycle up to 6 cycles. The first dose is given as 70 to 90 mg/m\^2. Subsequent doses may be escalated up to 90 mg/m\^2, if applicable and as per local guidelines.
BIOLOGICALRituximab
Administered as an IV infusion on Day 1 of each 28-day cycle. The initial dose is 375 mg/m\^2 (cycle 1) followed by 500 mg/m\^2 for remaining cycles.
BIOLOGICALTruxima
Administered as an IV infusion on Day 1 of each 28-day cycle. The initial dose is 375 mg/m\^2 (cycle 1) followed by 500 mg/m\^2 for remaining cycles.
BIOLOGICALRuxience
Administered as an IV infusion on Day 1 of each 28-day cycle. The initial dose is 375 mg/m\^2 (cycle 1) followed by 500 mg/m\^2 for remaining cycles.
BIOLOGICALRiabni
Administered as an IV infusion on Day 1 of each 28-day cycle. The initial dose is 375 mg/m\^2 (cycle 1) followed by 500 mg/m\^2 for remaining cycles.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The main inclusion and
Exclusion criteria
include but are not limited to the following: Inclusion Criteria: * Confirmed diagnosis of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) and active disease clearly documented to have a need to initiate therapy * Has previously untreated CLL/SLL participants without tumor protein 53 (TP53) aberrations and documented 11q status and immunoglobulin heavy chain gene (IGHV) mutational status * The ability to swallow and retain oral medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 as Assessed by Blinded Independent Central Review (BICR) | Up to approximately 49 months | 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 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria 2018 as assessed by blinded independent central review (BICR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Up to approximately 94 months | OS is defined as the time from randomization to death due to any cause. |
| Objective Response Rate (ORR) per iwCLL Criteria 2018 as Assessed by BICR | Up to approximately 36 months | 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 to Next Therapy (TTNT) | Up to approximately 94 months | TTNT is defined as the time from randomization to initiation of the first dose of a new systemic anticancer therapy for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) or death due to any cause, whichever occurs first. |
| Duration of Response (DOR) per iwCLL Criteria 2018 as Assessed by BICR | Up to approximately 94 months | For participants who demonstrate a CR, CRi, nPR, or PR per iwCLL criteria 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. |
| Number of Participants Who Experience an Adverse Event (AE) | Up to approximately 94 months | 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. |
| Number of Participants Who Discontinue Study Treatment Due to an AE | Up to approximately 94 months | 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. |
Countries
Australia, Brazil, Bulgaria, Chile, China, Colombia, Denmark, Guatemala, Hong Kong, Hungary, Lithuania, Malaysia, Mexico, Poland, Romania, Singapore, South Africa, Taiwan, Turkey (Türkiye), Ukraine, United States
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed