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A clinical study to assess the effectiveness and safety of LOXO-305 compared to standard of care treatment chosen by the Investigator in patients with previously treated Mantle Cell Lymphoma
EU CTIS ID: 2023-507695-52-00
What this study is testing
To compare progression-free survival (PFS) of pirtobrutinib as monotherapy (Arm A) to Investigator choice of covalent Bruton’s tyrosine kinase (BTK) inhibitor monotherapy (Arm B) in patients with previously treated Mantle Cell Lymphoma (MCL)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Confirmed Mantle Cell Lymphoma (MCL) diagnosis
- Creatinine clearance of ≥ 30 mL/min according to Cockcroft/Gault Formula
- 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
You likely can't join if
- Prior treatment with an approved or investigational BTK inhibitor
- Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist.
- Vaccination with live vaccine within 28 days prior to randomization
- 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
See the full eligibility criteria
- Confirmed Mantle Cell Lymphoma (MCL) diagnosis
- Creatinine clearance of ≥ 30 mL/min according to Cockcroft/Gault Formula
- 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.
- Prior treatment with an approved or investigational BTK inhibitor
- Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist.
- Vaccination with live vaccine within 28 days prior to randomization
- 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) absorption
- Ongoing chronic treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers which cannot be stopped within 3-5 half lives of the CYP3A inhibitor therapy prior to start of study drug treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- Israel
- Australia
- United States
- Taiwan
- United Kingdom
- New Zealand
- Canada
- Russian Federation
- China
- Brazil
- Switzerland
- Korea, Republic of
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; Israel; Australia; United States; Taiwan; United Kingdom and 7 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 EU CTIS; the study team decides eligibility.