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)
- How long the study runs
- Study runs about 93 months (dates as stated)
- About the drug or intervention
- Nemtabrutinib — drug: Nemtabrutinib tablets administered orally QD.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 490
- Started
- 2021-04-05
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for hematologic malignancies
- • Phase2 - 490 participants
- • The purpose of this study is to evaluate the safety and efficacy of nemtabrutinib (formerly ARQ 531) in participants with hematologic malignancies of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Richter's transformation, marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), follicular lymphoma (FL), and Waldenström's macroglobulinemia (WM)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with hematologic malignancies
Where?
- • Bristol - Bristol Haematology and Oncology Centre ( Site 2610)
- • Nottingham - Nottingham University Hospitals NHS Trust. City Hospital Campus ( Site 2601)
- • Windsor - GenesisCare - Windsor ( Site 2608)
- • London - Sarah Cannon Research Institute UK ( Site 2612)
- • +4 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The purpose of this study is to evaluate the safety and efficacy of nemtabrutinib (formerly ARQ 531) in participants with hematologic malignancies of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Richter's transformation, marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), follicular lymphoma (FL), and Waldenström's macroglobulinemia (WM).
More detail
This study will be performed in 2 parts: Dose Escalation and Confirmation (Part 1) and Cohort Expansion (Part 2). Following determination of the recommended phase 2 dose (RP2D) in Part 1, the study plans to proceed with Part 2 using 8 disease-specific expansion cohorts (Cohorts A to H).
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:
- ✓ to eliminate the study intervention after last dose of study intervention
- ✓ (Part 1 only)
- ✓ a covalent
- ✓ and are BTKi treatment naive
What the study is looking for
- ✓Has an activity scale (ECOG) performance status of 0 to 2 within 7 days before C1D1 (the first...
- ✓Has a expected to live at least 3 $2, based on the investigator assessment
- ✓Has the ability to swallow and retain oral medication
- ✓Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at...
- ✓Has healthy organ
Who cannot take part
- ✗Has active HBV/HCV infection (Part 1 and Part 2)
- ✗Has active central nervous system (CNS) disease
- ✗Has an active infection requiring treatment that goes through your whole body
- ✗Has received prior systemic anti-cancer therapy within 5 half-lives or 4 weeks (if prior therapy was a monoclonal...
- ✗Is currently participating in or has participated in a study of an investigational agent or has used an...
See the full criteria
Where Is This Study? (8 UK sites)
Bristol Haematology and Oncology Centre ( Site 2610)
Bristol BS2 8ED, United Kingdom
Nottingham University Hospitals NHS Trust. City Hospital Campus ( Site 2601)
Nottingham NG5 1PF, United Kingdom
GenesisCare - Windsor ( Site 2608)
Windsor SL4 3HD, United Kingdom
Sarah Cannon Research Institute UK ( Site 2612)
London W1G 6AD, United Kingdom
GenesisCare - Oxford ( Site 2607)
Oxford OX4 6LB, United Kingdom
GenesisCare - Cambridge ( Site 2611)
Newmarket CB8 7XN, United Kingdom
The Royal Marsden NHS Foundation Trust. ( Site 2606)
Sutton SM2 5PT, United Kingdom
The Christie NHS Foundation Trust ( Site 2602)
Manchester M20 4BX, United Kingdom
How to Get in Touch
Toll Free Number
Sponsor contactCONTACT
