Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell … (NCT04662255) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)
United States, Australia, Austria500 participantsStarted 2021-04-08
Plain-language summary
This is a study for participants with a type of blood cancer called mantle cell lymphoma (MCL). The main purpose is to compare pirtobrutinib (LOXO-305) to other drugs that work in a similar way that have already been approved by the United States Food and Drug Administration (US FDA). Participation could last up to two years, and possibly longer, if the disease does not progress.
Who can participate
Age range
18 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:
* Confirmed MCL diagnosis
* Previously treated with at least one prior line of systemic therapy for MCL
* Measurable disease per Lugano criteria
* Eastern Cooperative Oncology Group (ECOG) 0-2
* Absolute neutrophil count ≥ 0.75 × 109/L without granulocyte-colony stimulating factor support within 7 days of screening
* Hemoglobin ≥ 8 g/dL not requiring transfusion support or growth factors within 7 days of screening
* Platelets ≥ 50 × 109/L not requiring transfusion support or growth factors within 7 days of screening.
* AST and ALT ≤ 3.0 x upper limit of normal (ULN)
* Total bilirubin ≤ 1.5 x ULN.
* Creatinine clearance of ≥ 30 mL/min according to Cockcroft/Gault Formula
Exclusion Criteria:
* Prior treatment with an approved or investigational BTK inhibitor
* History of bleeding diathesis
* History of stroke or intracranial hemorrhage within 6 months of randomization
* History of allogeneic or autologous stem cell transplant (SCT) or chimeric antigen receptor modified T-cell (CAR-T) therapy within 60 days of randomization
* Clinically significant cardiovascular disease
* Prolonged QT interval corrected using Fridericia's formula (QTcF) \> 470 ms on 2/3 consecutive ECGs, and mean QTcF\>470 ms on all 3 ECGs
* Known HIV infection or active HBV, HCV, or CMV infections. (Certain participants with controlled HBV infections may still be eligible)
* Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) abs…
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.
What they're measuring
1
To compare progression-free survival (PFS) of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) in patients with previously treated mantle cell lymphoma (MCL)