A Comparison of Three Chemotherapy Regimens for the Treatment of Patients With Newly Diagnosed Ma… (NCT04115631) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Comparison of Three Chemotherapy Regimens for the Treatment of Patients With Newly Diagnosed Mantle Cell Lymphoma
United States360 participantsStarted 2019-12-13
Plain-language summary
This phase II trial compares three chemotherapy regimens consisting of bendamustine, rituximab, high dose cytarabine, and acalabrutinib and studies how well they work in treating patients with newly diagnosed mantle cell lymphoma. Drugs used in chemotherapy, such as bendamustine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. This study is being done to find out if one the drug combinations of bendamustine, rituximab, high dose cytarabine, and acalabrutinib is better or worse than the usual approach for mantle cell lymphoma.
Who can participate
Age range
18 Years – 70 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:
* Baseline measurements and evaluations must be obtained within 6 weeks of randomization to the study. Abnormal PET or CT scans may constitute evaluable disease. Patient must have at least one objective measurable disease parameter. Measurable disease in the liver is required if the liver is the only site of lymphoma.
* MIPI score must be calculated and entered in Oncology Patient Enrollment Network (OPEN).
* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
* Patients must have untreated histologically confirmed mantle cell lymphoma, with cyclin D1 (BCL1) expression by immunohistochemical stains and/or t(11;14) by cytogenetics or fluorescent in situ hybridization (FISH). The diagnosis must be confirmed by formal hematopathology review at the enrolling center.
* Patients being treated with gastric reducing agents proton pump inhibitors must be switched to an alternative drug before starting acalabrutinib.
* Absolute neutrophil count (ANC) \>= 1,000/mcL (obtained with 14 days of randomization). If disease includes marrow involvement or hypersplenism, please reference the below revised ANC requirement:
* ANC \>= 500/mcL
* Platelets \>= 75,000 mcL (obtained with 14 days of randomization). If disease includes involvement or hypersplenism, please reference the below revised platelet requirement:
* Platelets \>= 25,000/mcL
* Total bilirubin =\< 2 x institutional upper limit of normal (ULN) (obtained with 14 d…
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.
1This trial is in Phase 2 and is comparing three different chemotherapy regimens for newly diagnosed mantle cell lymphoma — can you explain what it means that it's Phase 2, and how much is already known about the safety and effectiveness of these approaches?
2The trial is measuring success by looking at both PET/CT scan results and something called minimal residual disease negativity in the blood — can you explain what MRD negativity means for mantle cell lymphoma and why that combination of measures matters for my situation?
3Since this trial is listed as 'active but not recruiting,' does that mean enrollment is closed, and if so, are there similar trials or regimens being studied that might still be open to me?
4How do the three chemotherapy regimens being compared in this trial differ from the standard treatment I would receive outside of a trial, and which approach would you recommend for someone in my specific situation?
5Chemotherapy regimens can vary a lot in terms of how often I'd need to come in, how long treatment lasts, and what side effects to expect — based on what's known about these three regimens, how demanding would participation likely be on my day-to-day life?
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.