| TITRE |
(EN) A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma |
| PROTOCOLE ID |
BRUIN-CLL-314 |
| CLINICAL TRIAL.gov ID |
NCT05254743 |
| TYPE(S) DE CANCER |
Leucémie lymphoïde chronique (LLC) |
| PHASE |
Phase III |
| TYPE D'ÉTUDE |
Clinique |
| INSTITUTION |
CHU DE QUEBEC – UNIVERSITE LAVAL
11 Côte du Palais
(418) 525-4444
|
| VILLE |
Québec
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
Robert Delage
|
| COORDONATEUR(RICE) |
Philippe Nadeau
philippe.nadeau@chudequebec.ca
418-649-0252 poste 63115
|
| STATUT |
Fermé
|
| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- Adequate organ function
- Platelets greater than or equal to (≥)50 x 10?/liter (L), hemoglobin ≥8 grams/deciliter (g/dL), and absolute neutrophil count ≥0.75 x 10?/L
- Kidney function: Estimated creatinine clearance ≥30 milliliters per minute (mL/min)
|
| CRITÈRES D'EXCLUSION |
(EN)
- Known or suspected Richter's transformation to diffuse large B-cell lymphoma (DLBCL), prolymphocytic leukemia, or Hodgkin's lymphoma at any time preceding enrollment
- Known or suspected central nervous system (CNS) involvement
- A significant history of renal, neurologic, psychiatric, endocrine, metabolic or immunologic disease
- Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia [AIHA], idiopathic thrombocytopenic purpura [ITP])
- Significant cardiovascular disease
- Active hepatitis B or hepatitis C
- Active cytomegalovirus (CMV) infection
- Active uncontrolled systemic bacterial, viral, or fungal infection
- Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count
- Clinically significant active malabsorption syndrome or other condition likely to affect GI absorption of the oral-administered study treatments
- Ongoing inflammatory bowel disease
- Prior exposure to BTK inhibitor (covalent or noncovalent)
- Concurrent use of investigational agent or anticancer therapy except hormonal therapy
- Participants requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist
- Use of ≥ 20 mg prednisone daily or equivalent dose of steroid at the time of first dose of study drug
- Vaccination with a live vaccine within 28 days prior to randomization
- Participants receiving chronic therapy with a strong cytochrome P450 (CYP)3A inhibitor (except posaconazole and voriconazole) which cannot be stopped within 3-5 half lives of the CYP3A inhibitor therapy prior to start of study drug treatment.
- Participants with known hypersensitivity, including anaphylaxis, to any component or excipient of pirtobrutinib or ibrutinib
|
