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Compares treatment options for Mantle Cell Lymphoma
Official title Testing Continuous Versus Intermittent Treatment With the Study Drug Zanubrutinib for Older Patients With Previously Untreated Mantle Cell Lymphoma
ClinicalTrials.gov ID: NCT05976763
What this study is testing
What is Zanubrutinib?
Zanubrutinib is an investigational medicine, given as an once-daily infusion into a vein, 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
- This phase III trial tests whether continuous or intermittent zanubrutinib after achieving a complete remission (CR) with rituximab works in older adult patients with mantle cell lymphoma (MCL) who have not received treatment in the past (previously untreated). Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread.
- Phase 3: a large, late-stage study
- 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 60 and older
You may be able to join if
- Histologically confirmed mantle cell lymphoma with cyclin D1 (BCL1) expression by immunohistochemical stains and/or evidence of CCND1 rearrangement...
- Any stage allowed (stage I-IV)
- Patient must have at least one objective measurable disease parameter by PET or CT. Measurable disease in the liver is required if the liver is the...
- Steroids for management of mantle cell lymphoma are allowed up to a dose of prednisone 100mg/day (or equivalent) for up to 7 days prior to...
- No prior systemic treatment for mantle cell lymphoma
See the full eligibility criteria
- Histologically confirmed mantle cell lymphoma with cyclin D1 (BCL1) expression by immunohistochemical stains and/or evidence of CCND1 rearrangement or t(11;14)(q13;q32) as confirmed by the enrolling center (such as by...
- Any stage allowed (stage I-IV)
- Patient must have at least one objective measurable disease parameter by PET or CT. Measurable disease in the liver is required if the liver is the only site of lymphoma OR bone marrow involvement by MCL
- Steroids for management of mantle cell lymphoma are allowed up to a dose of prednisone 100mg/day (or equivalent) for up to 7 days prior to registration
- No prior systemic treatment for mantle cell lymphoma
- No prior radiation treatment for stage I MCL
- No prior exposure to a BTK inhibitor or anti-CD20 monoclonal antibody
- No prior stem cell transplant
- Age \>= 70 years OR age \>= 60 to \ = 30ml/minute (min); d) Eastern Cooperative Oncology Group (ECOG) performance status of 2, which poses an unacceptable risk of toxicity for high-dose therapy and stem cell...
- ECOG Performance Status 0-2
- Absolute neutrophil count (ANC) \>= 750/mm\^3 (without growth factor support within 7 days)
- Platelet count \>= 75,000/mm\^3 (or \>= 50,000/mm\^3 if thrombocytopenia is due to lymphoma) without growth factor support or transfusion within 7 days
- Creatinine clearance \>= 30 mL/ min determined by either: a) Estimation using the Cockcroft-Gault equation or b) Measurement by nuclear medicine scan or 24 hour urine collection
- Total bilirubin =\< 1.5 x upper limit of normal (ULN) (unless documented Gilbert's syndrome)
- Aspartate transferase (AST) / alanine transaminase (ALT) =\< 3 x ULN
- Patients should not be considered candidates for stem cell transplant or must have declined a stem cell transplant strategy
- No clinically significant cardiovascular disease including the following
- Unstable angina within 3 months before registration
- New York Heart Association class III or IV congestive heart failure
- History of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes)
- Known QT correction formula (QTcF) \> 480 msecs based on Fredericia's formula (unless pacemaker in place)
- History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- No active Hepatitis B or Hepatitis C infection. Patients with prior hepatitis B virus (HBV) exposure (positive HBV core antibody and/or surface antigen) are eligible if they have no detectable viral load, and are taking...
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- No history of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention
- No history of stroke or intracranial hemorrhage within 6 months prior to registration
- No disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or...
- Potential trial participants should have recovered from major surgery
- No vaccination with a live vaccine within 35 days prior to registration
- No hypersensitivity to zanubrutinib or rituximab or any of the other ingredients of the study drugs
- Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study.
- Patients on strong CYP3A4 inducers must discontinue the drug 14 days prior to registration.
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- Beverly Hills, California, United States
- Duarte, California, United States
- Irvine, California, United States
- Los Angeles, California, United States
- Derby, Connecticut, United States
- Fairfield, Connecticut, United States
- Glastonbury, Connecticut, United States
- Greenwich, Connecticut, United States
- Guilford, Connecticut, United States
- Hartford, Connecticut, United States
- New Haven, Connecticut, United States
- North Haven, Connecticut, United States
- Stamford, Connecticut, United States
- Torrington, Connecticut, United States
- Trumbull, Connecticut, United States
- Waterbury, Connecticut, United States
- Waterford, Connecticut, United States
- Newark, Delaware, United States
- Albany, Georgia, United States
+ 167 more site(s).
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; Beverly Hills, California, United States; Duarte, California, United States; Irvine, California, United States; Los Angeles, California, United States; Derby, Connecticut, United States and 181 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.