A Study of Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) in Second-line (2L) + Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (MK-1026-010/BELLWAVE-010).

Part of paid clinical trials in Springdale, Arkansas.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT05947851
Phase
PHASE3
Status
Recruiting
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Conditions

  • CLL
  • Leukemia, Chronic Lymphocytic
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Lymphoma, Small Lymphocytic
  • SLL
  • Small-Cell Lymphoma

Eligibility Criteria

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

Interventions

  • Nemtabrutinib — DRUG
    5, 20, 45, and 65 mg tablets
  • Venetoclax — DRUG
    10, 50, and 100 mg tablets
  • Rituximab — BIOLOGICAL
    100 mg/10 mL, 500 mg/50 mL (10 mg/mL) IV Infusion

Study Details

The purpose of this study is to assess the safety and tolerability and to confirm the dose of nemtabrutinib in combination with venetoclax in participants with R/R CLL/SLL. The primary study hypotheses are that the combination of nemtabrutinib plus venetoclax is superior to VR with respect to progression-free survival (PFS) per 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria as assessed by blinded independent central review (BICR).

Key Dates

Start date
Aug 8, 2023
Status verified
May 2026
Primary completion
Jun 1, 2032
Completion
Jul 1, 2035

Study Design

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

Arms

  • Experimental: Nemtabrutinib + Venetoclax
    Participants will receive nemtrabrutinib oral tablets at specified doses daily starting at Cycle 1 Day 1 (C1D1) and venetoclax oral tablets at doses of 20 mg up to 400 mg daily starting at Cycle 2 Day 1 (C2D1) up to 2 years post C2D1 or until progressive disease (PD) or discontinuation. A cycle = 4 weeks.
  • Active Comparator: Venetoclax + Rituximab
    Participants will receive venetoclax oral tablets at doses from 20 mg up to 400 mg daily starting at C1D1 on 4-week cycles up to 2 years and rituximab or biosimilar at 375 mg/m\^2 up to 500 mg/m2 intravenous infusion once per 28-day cycle starting at C2D1, for 6 total cycles. Treatment will continue until progressive disease (PD) or discontinuation.

Primary Outcome Measure

Part 1: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) [ Time Frame: Up to approximately 12 Weeks ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Highlands Oncology Group ( Site 5405)SpringdaleArkansas72762
Study Coordinator
479-872-8130
MemorialCare Health System - Long Beach Medical Center ( Site 5421)Long BeachCalifornia90806
Study Coordinator
562-933-7866
Memorial Hospital West ( Site 5410)Pembroke PinesFlorida33028
Study Coordinator
954-844-8318
Oregon Health and Science University ( Site 5425)PortlandOregon97239-3011
Study Coordinator
503-494-5058
Medical Oncology Associates, PS ( Site 5406)SpokaneWashington99208
Study Coordinator
509-462-2273
University of Wisconsin Hospital and Clinics-Carbone Cancer Center ( Site 5423)MadisonWisconsin53792-

Find similar trials in Springdale, AR

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Highlands Oncology Group· Springdale, ARMemorialCare Health System - Long Beach Medical Center· Long Beach, CAMemorial Hospital West· Pembroke Pines, FLOregon Health and Science University· Portland, ORMedical Oncology Associates, PS· Spokane, WAUniversity of Wisconsin Hospital and Clinics-Carbone Cancer Center· Madison, WI

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