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New treatment option for Mantle Cell Lymphoma
Official title Zanubrutinib Plus Rituximab for Patients With Indolent Mantle Cell Lymphoma
ClinicalTrials.gov ID: NCT05635162
What this study is testing
What is Zanubrutinib?
Zanubrutinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for mantle cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Phase II, multicentre, randomised, open-label study to assess the benefit of early intervention with fixed duration, time-limited zanubrutinib-rituximab in indolent mantle cell lymphoma (MCL)
- Phase 2: a mid-size study of how well it works
- Time commitment: about 30 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 18 years of age or over.
- Life expectancy ≥ 6 months.
- Pathologically confirmed MCL, with documentation of monoclonal B cells that have a chromosome translocation t(11;14)(q13;q32) and/or overexpress...
- Stage II-IV MCL measurable by CT imaging or by white cell count (WCC)/BM infiltration.
- 'Indolent' MCL, defined as 1 or more of the following:
You likely can't join if
- Any prior therapy for MCL, including prior radiotherapy.
- Central nervous system (CNS) involvement of MCL.
- Uncontrolled infection with HIV or any uncontrolled active systemic infection (e.g., bacterial, viral or fungal). Patients with well-controlled HIV...
- Hepatitis B or C serologic status: people who are hepatitis B core antibody (anti-HB core) positive and who are surface antigen (HBsAg) negative will...
- No progression requiring treatment since initial diagnosis.
- Vaccinated with live vaccines (not including messenger ribonucleic acid (mRNA), viral vector or other non-live COVID19 vaccines) within four weeks...
See the full eligibility criteria
Who can join
- 18 years of age or over.
- Life expectancy ≥ 6 months.
- Pathologically confirmed MCL, with documentation of monoclonal B cells that have a chromosome translocation t(11;14)(q13;q32) and/or overexpress cyclin D1, D2 or D3.
- Stage II-IV MCL measurable by CT imaging or by white cell count (WCC)/BM infiltration.
- 'Indolent' MCL, defined as 1 or more of the following:
- Observation with no treatment for a minimum of 6 months after the initial diagnosis
- Leukaemic non-nodal variant (lymphocytosis/splenomegaly only without nodal involvement)
- Low tumour volume (largest lymph node ≤ 3cm in maximal diameter), proliferation fraction (Ki67 or equivalent) ≤30% and classical morphology (non-blastoid/pleomorphic)
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
- Absolute neutrophil count ≥1.0 x 109/L and platelets ≥75 x 109/L independent of growth factor support.
- AST and/or ALT ≤3 x upper limit of normal (ULN).
- Total Bilirubin ≤1.5 x ULN unless due to Gilberts syndrome or of non-hepatic origin unless directly attributable to the patient's MCL.
- Calculated creatinine clearance ≥30 mL/min. Glomerular filtration rate (GFR) ≥30 mL/min directly measured with 24 hour urine collection, or creatinine clearance calculated according to the modified formula of Cockcroft...
- Able to give voluntary written informed consent.
- Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty.
- Negative serum or urine pregnancy test for women of childbearing potential (WOCBP).
- Willing to comply with the contraceptive requirements of the trial.
What rules you out
- Any prior therapy for MCL, including prior radiotherapy.
- Central nervous system (CNS) involvement of MCL.
- Uncontrolled infection with HIV or any uncontrolled active systemic infection (e.g., bacterial, viral or fungal). Patients with well-controlled HIV status (undetectable viral load) will not be excluded.
- Hepatitis B or C serologic status: people who are hepatitis B core antibody (anti-HB core) positive and who are surface antigen (HBsAg) negative will need to have a negative polymerase chain reaction (PCR) test. Those...
- No progression requiring treatment since initial diagnosis.
- Vaccinated with live vaccines (not including messenger ribonucleic acid (mRNA), viral vector or other non-live COVID19 vaccines) within four weeks prior to randomisation.
- Major surgical procedure within 28 days prior to randomisation. Note: If a subject had major surgery, they must have recovered adequately from any toxicity and/or complications from the intervention before the first...
- 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...
- Requirement for moderate or strong CYP3A inducers. Moderate and strong CYP3A inhibitors are allowed although these should be switched to agents causing less CYP3A inhibition where possible.
- Requirement for vitamin K antagonists (alternative anticoagulation is allowed (e.g. DOACs), but patients must be properly informed about the potential risk of bleeding alongside zanubrutinib). Requires ongoing treatment...
- Active bleeding or history of bleeding diathesis (e.g. haemophilia or von Willebrand disease) or history of spontaneous bleeding requiring blood transfusion or other medical intervention.
- Clinically significant cardiovascular disease such as uncontrolled arrhythmias, or history of ventricular tachycardia, ventricular fibrillation, torsades de points or myocardial infarction within 6 months of...
- History of stroke or intracranial haemorrhage within 6 months prior to randomisation.
- Any other severe medical or psychiatric illness that in the opinion of the investigator would interfere with participation in this clinical study.
- Malabsorption syndrome, unable to swallow capsules, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel that is likely to affect absorption, symptomatic inflammatory...
- Women who are pregnant or breastfeeding.
- Male participants with female partners of childbearing potential who are unwilling to use appropriate contraception methods.
- Concurrent treatment with another investigational agent.
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, known sensitivity or allergy to murine products.
- Known hypersensitivity to any active substance or to any of the excipients of one of the drugs used in the trial.
- Severe or debilitating pulmonary disease.
- Underlying medical conditions that, in the investigator's opinion, will render the administration of study drug hazardous or obscure the interpretation of toxicity or AEs
- Concurrent participation in another therapeutic clinical trial.
- Active and/or ongoing autoimmune anaemia and/or autoimmune thrombocytopenia (eg. idiopathic thrombocytopenia purpura).
The study team makes the final eligibility decision.
Where it's taking place
- Derby, United Kingdom
- Glasgow, United Kingdom
- Liverpool, United Kingdom
- London, United Kingdom
- Manchester, United Kingdom
- Norwich, United Kingdom
- Nottingham, United Kingdom
- Oxford, United Kingdom
- Plymouth, United Kingdom
- Southampton, United Kingdom
- Truro, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 30 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Derby, United Kingdom; Glasgow, United Kingdom; Liverpool, United Kingdom; London, United Kingdom; Manchester, United Kingdom; Norwich, United Kingdom and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.