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NCT05947851
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).
Phase 3 trial testing Nemtabrutinib in Leukemia, Lymphocytic, Chronic, B-Cell in 735 participants. Currently enrolling.
1 June 2032
Quick facts
| Lead sponsor | Merck Sharp & Dohme LLC |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 735 |
| Start date | 8 August 2023 |
| Primary completion | 1 June 2032 |
| Estimated completion | 1 July 2035 |
| Sites | 52 locations across France, Colombia, Italy, South Africa, Belgium, Chile, United Kingdom, Germany |
Drugs / interventions tested
- Nemtabrutinib — full drug profile →
- Venetoclax (venetoclax) — full drug profile →
- Rituximab — full drug profile →
Conditions studied
- Leukemia, Lymphocytic, Chronic, B-Cell — all drugs for Leukemia, Lymphocytic, Chronic, B-Cell →
- Leukemia, Chronic Lymphocytic — all drugs for Leukemia, Chronic Lymphocytic →
- Small-Cell Lymphoma — all drugs for Small-Cell Lymphoma →
- Lymphoma, Small Lymphocytic — all drugs for Lymphoma, Small Lymphocytic →
Sponsor
Merck Sharp & Dohme LLC — full company profile →
Who can join
18 and older, any sex, with Leukemia, Lymphocytic, Chronic, B-Cell or Leukemia, Chronic Lymphocytic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
B cell receptor signaling and associated pathways in the pathogenesis of chronic lymphocytic leukemia.
Schmid VK, Hobeika E. · · 2024 · cited 16× · PMID 38469232 · DOI 10.3389/fonc.2024.1339620 -
Update on the management of relapsed/refractory chronic lymphocytic leukemia.
Bennett R, Seymour JF. · · 2024 · cited 15× · PMID 38378673 · DOI 10.1038/s41408-024-01001-1 -
New Means and Challenges in the Targeting of BTK.
Nawaratne V, Sondhi AK, Abdel-Wahab O, Taylor J. · · 2024 · cited 12× · PMID 38578606 · DOI 10.1158/1078-0432.ccr-23-0409 -
Double Strike in Chronic Lymphocytic Leukemia-The Combination of BTK and BCL2 Inhibitors in Actual and Future Clinical Practice.
Zygmunciak P, Dancewicz H, Stróżna K, Błażowska O, et al · · 2025 · cited 2× · PMID 40243993 · DOI 10.3390/ijms26073193 -
The Development of Novel Therapies for Chronic Lymphocytic Leukaemia in the Era of Targeted Drugs.
Robak T, Iskierka-Jażdżewska E, Puła A, Robak P, et al · · 2025 · cited 1× · PMID 41303291 · DOI 10.3390/jcm14228247 -
Consensus in CLL: global needs matter.
Shadman M, Fakhri B, Jain N. · · 2025 · cited 1× · PMID 40067336 · DOI 10.1182/bloodadvances.2024015355 -
The Role of Tumor Microenvironment and Targeted Therapy in Chronic Lymphocytic Leukemia.
Saleh K, Arbab A, Khalife N, Khoury R, et al · · 2025 · PMID 40864758 · DOI 10.3390/cimb47080604
Verify or expand the search:
- PubMed search for NCT05947851
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Nemtabrutinib
Trials testing the same drug.
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- NCT07232589 — A Study of the Effect of Diltiazem on the Plasma Levels of Nemtabrutinib (MK-1026-022) · Phase 1 · active not recruiting
- NCT06572618 — Nemtabrutinib With Rituximab for the Treatment of Patients With Mantle Cell Lymphoma · Phase 2 · recruiting
- NCT06442436 — A Study of Nemtabrutinib in Participants With Moderate Hepatic Impairment (MK-1026-015) · Phase 1 · recruiting
Other recruiting trials for Leukemia, Lymphocytic, Chronic, B-Cell
Currently open trials in the same condition.
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Other Merck Sharp & Dohme LLC trials
Trials by the same sponsor.
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- NCT07513376 — A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (M · Phase 3 · not yet recruiting
- NCT07532304 — A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Parti · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05947851 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
- Last refreshed: 13 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05947851.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing