Nemtabrutinib Plus Venetoclax for CLL

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).

Recruiting Phase 3 Interventional Study
Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Chronic Lymphocytic Small-Cell Lymphoma Lymphoma, Small Lymphocytic CLL SLL
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
735 (estimated)
Sponsor
Merck Sharp & Dohme LLC · Industry
Who this trial is looking for

This trial is looking for people with chronic lymphocytic leukemia (CLL) whose disease has returned after treatment. Participants will receive a combination of two medications to see if this treatment is safer and more effective than another standard treatment.

Are You a Good Fit for This Trial?
Rules you out Richter TransformationCentral nervous system involvementHIV with specific recent health issues

You may be able to join if

  • I have been diagnosed with chronic lymphocytic leukemia.
  • I have had at least one previous treatment.
  • I have disease markers.
  • I can swallow and keep down oral medications.
  • I have a life expectancy of at least 3 months.
  • I have an Eastern Cooperative Oncology Group performance status of 0 to 2.
  • I'm not pregnant or breastfeeding, or I use effective contraception.

You may not be able to join if

  • I have an active hepatitis B or C infection.
  • I have a serious heart condition.
  • I have had another type of cancer that required treatment in the last 2 years.
  • I have had an active infection needing systemic therapy recently.
  • I have received prior systemic anticancer therapy within the last month.
  • I have had major surgery and haven't fully recovered.
  • I have severe bleeding disorders.
  • I have a known allergy to some of these medications.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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) cr…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Confirmed diagnosis of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and active disease clearly documented to initiate therapy * Deletion (Del) (17p) status, tumor protein 53 (TP53) mutation status, and immunoglobulin heavy chain gene (IGHV) mutation status…
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