Acalabrutinib and Rituximab in Previously Untreated Mantle Cell Lymphoma (NCT05004064) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Acalabrutinib and Rituximab in Previously Untreated Mantle Cell Lymphoma
United Kingdom48 participantsStarted 2023-11-30
Plain-language summary
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 participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Men and women ≥ 60 years of age.
. Pathologically confirmed MCL, with documentation of monoclonal B cells that have a chromosome translocation t(11;14)(q13;q32) and/or overexpress cyclin D1.
. Stage II-IV MCL and requiring treatment in the opinion of the treating clinician.
. Eastern Cooperative Oncology Group (ECOG) performance status 0-3
. One or more of the following:
. Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules/tablets without difficulty.
. Negative serum or urine pregnancy test for women of childbearing potential (WOCBP).
. Willing to comply with the contraceptive requirements of the trial.
Exclusion criteria
. Any prior therapy (including targeted inhibitors) for MCL (other than prior localised radiotherapy, a 10-day pulse of high dose steroids or continuous prednisolone above 20mg od or equivalent for symptom control).
. Patients considered by the investigator fit enough to receive standard, full dose cytotoxic immunochemotherapy as treatment for non-transplant eligible MCL e.g., full dose R-CHOP, VR-CAP, R-Bendamustine, R-FC.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Prior malignancy (or any other malignancy requiring active treatment), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, localised prostate cancer or other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to \< 5 years.
. Clinically significant cardiovascular disease such as uncontrolled arrhythmias, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association (NYHA) Functional Classification (33), or corrected QT interval (QTc) \> 480 msec at screening.
. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
. 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 study drug (including active product or excipient components).
. Active bleeding or history of bleeding diathesis (e.g. haemophilia or von Willebrand disease).