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BRUIN-CLL-314 - A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (J2N-OX-JZNU - LOXO-BTK-20030)

Studio Clinico

Patologia: Neoplasie ematologiche

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: III

Linee di trattamento: Prima linea, Seconda linea

Criteri di inclusione: 

- 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 10⁹/liter (L) or ≥30 x 10⁹/L in participants with documented bone marrow involvement considered to impair hematopoiesis,
    - Hemoglobin ≥8 grams/deciliter (g/dL) or ≥6 g/dL in participants with documented bone marrow involvement considered to impair hematopoiesis
    - Absolute neutrophil count ≥0.75 x 10⁹/L or ≥0.50 × 10⁹/L in participants with documented bone marrow involvement considered to impair hematopoiesis
    - Kidney function: Estimated creatinine clearance ≥30 milliliters per minute (mL/min).

Criteri di esclusione: 

- 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 including ejection fraction < 40% and any grade ongoing atrial fibrillation or atrial flutter
- Hepatitis B or hepatitis C testing indicating active/ongoing infection, based on Screening laboratory tests
- 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.

Trattamento sperimentale: 

Pirtobrutinib (Loxo 305)

Trattamento di controllo: 

Ibrutinib

Centri partecipanti

Nord Italia

AO SS Antonio e Biagio e C. Arrigo
Via Venezia 16 - 15100 Alessandria - AL

 

Ospedale S.Orsola Malpighi, Università di Bologna
Via Pietro Albertoni 15 - 40138 Bologna - BO
Istituto di Ematologia

 

IRCCS - IRST Meldola Dino Amadori
Via P. Maroncelli 40 - 47014 Meldola - FC

 

Fondazione IRCCS Ca Granda Ospedale Maggiore
Via Della Commenda 10 - 20122 Milano - MI

 

Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI

 

Ospedale San Raffaele di Milano
Via Olgettina 60 - 20132 Milano - MI

 

AUSL/IRCCS di Reggio Emilia
Viale Risorgimento 80 - 42123 Reggio nell'Emilia - RE

 

IRCCS Candiolo (TO)
St.Provinciale Km 3,95 SP142 - 10060 Candiolo - TO

 

AOU Città della Salute e della Scienza di Torino
Corso Bramante 88 - 10126 Torino - TO

 

AOUI Verona - Borgo Roma
Piazzale Ludovico Antonio Scuro 10 - 37134 Verona - VR

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2021-003206-41

Data di inserimento: 08.03.2024

Promotore

Loxo Oncology, Inc.

Principal Investigator ITALIA

Riferimento: Dr. Info non disponibile

Telefono: 00000

Email: nd@nd.it

Localita: nd

 

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