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).

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, and 45 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

First listed

Jul 17, 2023

Start date

Aug 8, 2023

Status verified

Aug 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

• Toll Free Number
  1-888-577-8839
  [email protected]

Locations (16)

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