Actively Recruiting
Acalabrutinib and Rituximab in Previously Untreated Mantle Cell Lymphoma
Led by University College, London · Updated on 2025-04-09
48
Participants Needed
12
Research Sites
261 weeks
Total Duration
On this page
Sponsors
U
University College, London
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Acalabrutinib and Rituximab in Previously Untreated Mantle Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women 60 years of age or older
- Pathologically confirmed mantle cell lymphoma with specific genetic markers or cyclin D1 overexpression
- Stage II to IV mantle cell lymphoma requiring treatment as determined by the doctor
- ECOG performance status between 0 and 3
- At least one of the following: age 80 or older; CIRS-G score of 6 or higher; left ventricular ejection fraction 50% or less; significant co-morbidities or cardiac risk factors making standard chemotherapy unsuitable; heart failure NYHA grade II not due to lymphoma; impaired respiratory function below 75% predicted not due to lymphoma; significant respiratory illness such as moderate COPD or bronchiectasis; other co-morbidities precluding standard full-dose immuno-chemotherapy
- Ability and willingness to participate in all study procedures including swallowing capsules/tablets
- Negative pregnancy test for women of childbearing potential
- Willingness to follow contraceptive requirements
- Provided written informed consent
You will not qualify if you...
- Prior treatment for mantle cell lymphoma except limited radiotherapy or short-term steroids
- Considered fit for standard full-dose cytotoxic immunochemotherapy by investigator
- Prior malignancy requiring treatment except certain skin, cervical, or prostate cancers disease-free for 2 years or more
- Clinically significant cardiovascular disease including recent myocardial infarction or severe heart failure
- Gastrointestinal conditions affecting absorption or recent major gastrointestinal surgery
- Known HIV infection or uncontrolled active systemic infections
- Known allergy or anaphylaxis to study drugs or components
- Active bleeding disorders or uncontrolled autoimmune blood disorders
- Recent gastrointestinal ulcer diagnosed within 3 months
- Need for strong CYP3A4 inhibitors or inducers
- Use of warfarin or equivalent anticoagulants within 7 days prior to first dose
- Abnormal blood clotting test results beyond specified limits
- Current use of proton pump inhibitors unless switched to alternatives
- Recent significant cerebrovascular events within 6 months
- Major surgery within 28 days prior to first dose without full recovery
- Hepatitis B or C infection based on serology and PCR testing with specific exclusions
- Low neutrophil or platelet counts unless due to lymphoma-related marrow involvement
- Elevated liver enzymes or bilirubin except for specific benign causes
- Severe kidney impairment with creatinine clearance below 30 mL/min
- Central nervous system involvement by lymphoma
- Pregnancy or breastfeeding
- Participation in another therapeutic clinical trial
- Live vaccine administration within 28 days prior to first dose
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 12 locations
1
The Royal Bournemouth Hospital
Bournemouth, United Kingdom
Actively Recruiting
2
University Hospital of Wales
Cardiff, United Kingdom
Actively Recruiting
3
Royal Cornwall Hospital
Cornwall, United Kingdom
Actively Recruiting
4
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
Actively Recruiting
5
St. Bartholomew's Hospital
London, United Kingdom
Actively Recruiting
6
University College London Hospital
London, United Kingdom
Actively Recruiting
7
The Christie Hospital
Manchester, United Kingdom
Actively Recruiting
8
Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, United Kingdom
Actively Recruiting
9
Norfolk and Norwich University Hospital
Norwich, United Kingdom
Actively Recruiting
10
Cancer and Haematology Centre, Churchill Hospital
Oxford, United Kingdom
Actively Recruiting
11
Derriford Hospital
Plymouth, United Kingdom
Actively Recruiting
12
Royal Stoke Hospital
Stoke-on-Trent, United Kingdom
Actively Recruiting
Research Team
M
Max McLaughlin Callan
CONTACT
M
Marissa Arfan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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