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
- Acalabrutinib (drug), Rituximab (drug)
- How long the study runs
- Study runs about 55 months (dates as stated)
- About the drug or intervention
- Acalabrutinib — drug: Patients will receive acalabrutinib 100mg twice daily for up to six 28 day cycles. · Rituximab — drug: Patient will receive rituximab 375 mg/m2 IV on day 1 (+/- 3 days) of each cycle, for a maximum of 6 cycles
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 60 Years and over
- Who
- All
- Number of participants
- 48
- Started
- 2023-11-30
- Last checked
- 2026-03
Plain English Summary
What is this study?
- • Testing a new treatment for mantle cell lymphoma
- • Phase2 - 48 participants
- • This is a phase II, single-arm, open-label, multicentre study of acalabrutinib and rituximab for elderly or frail patients with previously untreated mantle cell lymphoma
Who can take part?
- • Ages 60 Years and over
- • Diagnosed with mantle cell lymphoma
Where?
- • Bournemouth - The Royal Bournemouth Hospital
- • Cardiff - University Hospital of Wales
- • Glasgow - Beatson West of Scotland Cancer Centre
- • London - St. Bartholomew's Hospital
- • +8 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This is a phase II, single-arm, open-label, multicentre study of acalabrutinib and rituximab for elderly or frail patients with previously untreated mantle cell lymphoma.
More detail
This is a Phase II, multicentre, single arm, open label pilot study to assess the safety and efficacy of acalabrutinib in combination with rituximab for previously untreated elderly frail mantle cell lymphoma patients. 48 patients will be recruited from 12 UK centres over 30 months. Patients will receive acalabrutinib and rituximab for up to six cycles. The cycle length is 28 days. Specifically, patients will receive acalabrutinib, orally, at a dose of 100 mg twice daily for 28 days and rituximab 375 mg/m2 intravenously on day 1 (+/-3) of each cycle.\* Patients with any degree of response at the Week 12 (end of cycle 3) and Week 24 assessments (end of cycle 6) will continue with acalabrutinib monotherapy at a dose of 100 mg twice daily until disease progression, the development of unacceptable toxicity or any other reason (whichever occurs sooner). \* Note: Acalabrutinib may be administered at a dose of 100 mg od po for cycle 1 day 1-7 at the local investigator's discretion. The dose should be escalated to full dose (100 mg bd) by day 8, cycle 1 if no toxicity is seen (see dose modification section). If a patient experiences toxicity during cycle 1 day 1-7 100 mg od po, the case must be discussed with the TMG to decide if acalabrutinib should continue. The CTC CARAMEL team should be contacted as soon as possible to arrange discussions with the TMG. Rituximab may be administered subcutaneously at a flat dose of 1400 mg from cycle 2 onwards following an intravenous dose of 375 mg/m2 in cycle 1. Consider splitting the first dose of rituximab at cycle 1 in the minority of MCL patients presenting with a white cell count of \>25 x 109/L. Consider splitting 25-50 mg/m2 on D1 and 325-350 mg/m2 on D2 of cycle 1 (to a total of 375 mg/m2 over D1/D2) according to investigator and site preference. Full dose 375 mg/m2 IV (or s/c equivalent) should be given in all patients from cycle 2 as a single dose. All patients will be followed up for a minimum of 2 years following being registered into the trial. For patients that have been in follow-up for more than 2 years, annual survival and disease status follow-up will continue until the end of the trial.
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: 60 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Men and women ≥ 60 years of age.
- ✓Pathologically confirmed MCL, with documentation of monoclonal B cells that have a chromosome translocation...
- ✓Stage II-IV MCL and requiring treatment in the opinion of the treating clinician.
- ✓activity scale (ECOG) performance status 0-3
- ✓One or more of the following:
Who cannot take part
- ✗Known history of infection with HIV or any uncontrolled active systemic infection (e.g., bacterial, viral or fungal).
- ✗Known history of drug-specific hypersensitivity or anaphylaxis to any the study treatment (including active product or...
- ✗Active bleeding or history of bleeding diathesis (e.g. haemophilia or von Willebrand disease).
- ✗Uncontrolled AIHA (autoimmune haemolytic anaemia) or ITP (idiopathic thrombocytopenic purpura).
- ✗Known presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening.
See the full criteria
Where Is This Study? (12 UK sites)
The Royal Bournemouth Hospital
Bournemouth, United Kingdom
Research Development & Support
clinicalresearch@bournemouth.ac.uk01202 961200University Hospital of Wales
Cardiff, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
St. Bartholomew's Hospital
London, United Kingdom
University College London Hospital
London, United Kingdom
Rajinder Sidhu - Associate Director, Research Governance and Operations
uclh.jro-communications@nhs.net020 3447 9825The Christie Hospital
Manchester, United Kingdom
Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, United Kingdom
Norfolk and Norwich University Hospital
Norwich, United Kingdom
Cancer and Haematology Centre, Churchill Hospital
Oxford, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
Royal Stoke Hospital
Stoke-on-Trent, United Kingdom
Royal Cornwall Hospital
Truro, United Kingdom
