At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Nemtabrutinib (drug), Venetoclax (drug), Rituximab (biological)
- How long the study runs
- Study runs about 143 months (dates as stated)
- About the drug or intervention
- 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
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 735
- Started
- 2023-08-08
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for leukemia, lymphocytic, chronic, b-cell
- • Phase3 - 735 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with leukemia, lymphocytic, chronic, b-cell
Where?
- • Nottingham - City Hospital, Nottingham University Hospitals-Hematology ( Site 5002)
- • London-Camden - University College London Hospital-Cancer Clinical Trials Unit ( Site 5001)
This is a simplified summary. Always discuss with your doctor before making any decisions.
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) criteria as assessed by blinded independent central review (BICR).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ before randomization for Part 2 participants only
What the study is looking for
- ✓Confirmed diagnosis of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and active disease clearly...
- ✓Deletion (Del) (17p) status, tumor protein 53 (TP53) mutation status, and immunoglobulin heavy chain gene (IGHV)...
- ✓Relapsed or refractory to at least 1 prior available therapy
- ✓Have at least 1 marker of disease burden
- ✓Has an activity scale (ECOG) performance status of 0 to 2 within 7 days before randomization
Who cannot take part
- ✗Has an active hepatitis B virus/ hepatitis C virus (HBV/HCV) infection
- ✗Has gastrointestinal (GI) dysfunction that may affect drug absorption
- ✗Has a known additional cancer that is progressing or has required active treatment within the past 2 years
- ✗Has diagnosis of Richter Transformation or active central nervous system (CNS) involvement by CLL/SLL
- ✗Has an active infection requiring treatment that goes through your whole body, such as intravenous (IV) antibiotics, during screening
See the full criteria
Where Is This Study? (2 UK sites)
City Hospital, Nottingham University Hospitals-Hematology ( Site 5002)
Nottingham NG5 1PF, United Kingdom
University College London Hospital-Cancer Clinical Trials Unit ( Site 5001)
London-Camden NW1 2PG, United Kingdom
How to Get in Touch
Toll Free Number
Sponsor contactCONTACT
