| Title |
A Phase 3 Open-Label, Randomized Study of Fixed Duration Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab Versus Venetoclax and Rituximab in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma |
| Protocole ID |
BRUIN CLL-322 |
| ClinicalTrials.gov ID |
NCT04965493 |
| Cancer Type(s) |
Chronic Lymphocytic Leukemia |
| Phase |
Phase III |
| Stage |
|
| Study Type |
Clinical |
| Drug |
Pirtobrutinib (LOXO-305) + venetoclax et rituximab versus venetoclax et rituximab |
| Institution |
CIUSSS DU CENTRE-OUEST-DE-L'ILE-DE-MONTREAL
 HOPITAL GENERAL JUIF SIR MORTIMER B.DAVIS
3755 rue de la Côte Ste. Catherine, Montréal, QC, H3T 1E2
|
| City |
|
| Principal Investigator |
Dr. Sonia Skamene
|
| Coordinator |
Edrian Gabrielle Bumanlag
514-840-8222 poste 23638
|
| Status |
Recruiting |
| Activation Date |
01-05-2023 |
| Eligibility Criteria |
- Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria
- Previous treatment with at least one line of therapy that may include a covalent Bruton's tyrosine kinase (BTK) inhibitor
- Platelets greater than or equal to (≥)50 x 10?/liter (L), hemoglobin ≥8 grams/deciliter (g/dL) and absolute neutrophil count ≥1.0 x 10?/L
- Adequate organ function
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- Estimated creatinine clearance ≥30 milliliters per minute (mL/min)
|
| Exclusion Criteria |
- Known or suspected Richter's transformation at any time preceding enrollment
- Prior therapy with a non-covalent (reversible) BTK inhibitor
- Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist
- Current treatment with strong cytochrome P450 (CYP) 3A4 (CYP3A4) inhibitors or inducers
- Prior therapy with venetoclax
- Central nervous system (CNS) involvement
- Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
- Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count
- Allogeneic stem cell transplantation (SCT) or chimeric antigen receptor (CAR)-T within 60 days
- Active hepatitis B or hepatitis C
- Known active cytomegalovirus (CMV) infection
- Uncontrolled immune thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia (AIHA)
- Significant cardiovascular disease
- Vaccination with a live vaccine within 28 days prior to randomization
-
Patients with the following hypersensitivity:
- Known hypersensitivity to any component or excipient of pirtobrutinib and venetoclax
- Prior significant hypersensitivity to rituximab
- Known allergy to allopurinol and inability to take uric acid lowering agent
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Groupe d'étude en oncologie du Québec