A Study of Nemtabrutinib vs Chemoimmunotherapy for Participants With Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Without TP53 Aberrations (MK-1026-008, BELLWAVE-008)

Part of paid clinical trials in Springdale, Arkansas.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT05624554
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nemtabrutinib — DRUG
    65 mg administered orally daily until disease progression, unacceptable toxicity, or discontinuation criteria met.
  • Fludarabine — DRUG
    25 mg/m\^2 administered via intravenous (IV) infusion on Days 1, 2, and 3 of each 28-day cycle up to 6 cycles.
  • Cyclophosphamide — DRUG
    250 mg/m\^2 administered via IV infusion on Days 1, 2, and 3 of each 28-day cycle up to 6 cycles.
  • Bendamustine — DRUG
    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.
  • Rituximab — BIOLOGICAL
    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.
  • Truxima — BIOLOGICAL
    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.
  • Ruxience — BIOLOGICAL
    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.
  • Riabni — BIOLOGICAL
    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.

Study Details

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).

Key Dates

Start date
Mar 16, 2023
Status verified
Mar 2026
Primary completion
May 19, 2027
Completion
Mar 17, 2031

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nemtabrutinib
    Administered daily via oral tablet.
  • Active Comparator: FCR or BR
    Investigator's choice of fludarabine plus cyclophosphamide plus rituximab (FCR) OR bendamustine plus rituximab (BR). Participants will receive either rituximab or specified approved rituximab biosimilar.

Primary Outcome Measure

Progression-Free Survival (PFS) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 as Assessed by Blinded Independent Central Review (BICR) [ Time Frame: Up to approximately 49 months ]

Locations (4)

FacilityCityStateZIPSite coordinators
Highlands Oncology Group ( Site 5205)SpringdaleArkansas72762-
Clermont Oncology Center ( Site 5224)ClermontFlorida34711-
Hattiesburg Clinic Hematology/Oncology ( Site 5216)HattiesburgMississippi39401-
Medical Oncology Associates, PS ( Site 5206)SpokaneWashington99208-

Find similar trials in Springdale, AR

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Highlands Oncology Group· Springdale, ARClermont Oncology Center· Clermont, FLHattiesburg Clinic Hematology/Oncology· Hattiesburg, MSMedical Oncology Associates, PS· Spokane, WA

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