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), Ibrutinib (drug), Acalabrutinib (drug)
- How long the study runs
- Study runs about 105 months (dates as stated)
- About the drug or intervention
- Nemtabrutinib — drug: Administered orally · Ibrutinib — drug: Administered orally · Acalabrutinib — drug: Administered orally
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 1,200
- Started
- 2023-12-13
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for chronic lymphocytic leukemia
- • Phase3 - 1,200 participants
- • The goal of this study is to evaluate nemtabrutinib compared with investigator's choice of ibrutinib or acalabrutinib in participants with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have not received any prior therapy
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with chronic lymphocytic leukemia
Where?
- • Bristol - Southmead Hospital ( Site 3010)
- • Lancaster - Royal Lancaster Infirmary ( Site 3012)
- • London - St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 3006)
- • Oxford - The Churchill Hospital ( Site 3007)
- • +6 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The goal of this study is to evaluate nemtabrutinib compared with investigator's choice of ibrutinib or acalabrutinib in participants with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have not received any prior therapy. The primary hypotheses are that (1) nemtabrutinib is non-inferior to ibrutinib or acalabrutinib with respect to objective response rate (ORR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 by blinded independent central review (BICR) and (2) nemtabrutinib is superior to ibrutinib or acalabrutinib with respect to progression free survival (PFS) per iwCLL Criteria 2018 by 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
What the study is looking for
- ✓The main inclusion criteria include but are not limited to the following:
- ✓Confirmed diagnosis of CLL/SLL and active disease clearly documented to have a need to initiate therapy.
- ✓Has at least 1 marker of disease burden.
- ✓Has an activity scale (ECOG) performance status of 0 to 2 within 7 days before randomization.
- ✓Has the ability to swallow and retain oral medication.
Who cannot take part
- ✗The main exclusion criteria include but are not limited to the following:
- ✗Has an active hepatitis B virus/ hepatitis C virus (HBV/HCV) infection.
- ✗Has gastrointestinal (GI) dysfunction that may affect drug absorption.
- ✗Has diagnosis of Richter Transformation or active central nervous system (CNS) involvement by CLL/SLL.
- ✗Has had acquired immune deficiency syndrome (AIDS)-defining opportunistic infection in the past 12 months before...
See the full criteria
Where Is This Study? (10 UK sites)
Southmead Hospital ( Site 3010)
Bristol BS10 5NB, United Kingdom
Royal Lancaster Infirmary ( Site 3012)
Lancaster LA1 4RP, United Kingdom
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 3006)
London EC1A 7BE, United Kingdom
The Churchill Hospital ( Site 3007)
Oxford OX3 7LE, United Kingdom
GenesisCare - Bristol ( Site 3011)
Bristol BS32 4SY, United Kingdom
GenesisCare - Cambridge ( Site 3001)
Newmarket CB8 7XN, United Kingdom
GenesisCare - Windsor ( Site 3002)
Windsor SL4 3HD, United Kingdom
Barnet Hospital ( Site 3005)
Barnet EN5 3DJ, United Kingdom
St James's University Hospital ( Site 3004)
Leeds LS9 7TF, United Kingdom
City Hospital, Nottingham University Hospitals NHS Trust ( Site 3003)
Nottingham NG5 1PB, United Kingdom
How to Get in Touch
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