Informazioni generali
  • Categoria della malattia Linfoma (BASEC)
  • Stato di reclutamento reclutamento non ancora iniziato (BASEC/ICTRP)
  • Luogo dello studio
    Berna, Zurigo
    (BASEC)
  • Responsabile dello studio Ivana Murfuni clinicaltrials@beonemed.com (BASEC)
  • Fonte dati BASEC: Importato da 21.09.2026 ICTRP: N/A
  • Ultimo aggiornamento 21.09.2026 08:00
HumRes67754 | SNCTP000006775 | BASEC2025-01594

A Study to Assess the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Cell Lymphocytic Lymphoma

  • Categoria della malattia Linfoma (BASEC)
  • Stato di reclutamento reclutamento non ancora iniziato (BASEC/ICTRP)
  • Luogo dello studio
    Berna, Zurigo
    (BASEC)
  • Responsabile dello studio Ivana Murfuni clinicaltrials@beonemed.com (BASEC)
  • Fonte dati BASEC: Importato da 21.09.2026 ICTRP: N/A
  • Ultimo aggiornamento 21.09.2026 08:00

Descrizione riassuntiva dello studio

The aim of this study is to assess the efficacy and safety of BGB-16673 compared to Pirtobrutinib in patients with relapsed and/or refractory (R/R) chronic lymphocytic leukemia (CLL) or small cell lymphocytic lymphoma (SLL) who have previously been treated with a covalent Bruton tyrosine kinase inhibitor (cBTKi). Study details: The duration of the study is approximately 3.5 years, excluding the pre-study period. Patients will receive treatment until unacceptable toxicity occurs or disease progression is confirmed by both the investigator and the IRC, or one of the specified criteria for treatment discontinuation is met, whichever occurs first. Refractory to previous cBTKi therapy – Patients who experienced disease progression between the first dose of the last cBTKi therapy and six months after the last dose of the last cBTKi therapy are considered refractory to the last cBTKi therapy. Relapse – The reoccurrence of CLL/SLL after a remission phase.

(BASEC)

Intervento studiato

Arm A: Patients randomized to Arm A will receive BGB-16673 200 mg orally once daily until one of the criteria for treatment discontinuation listed in Section 7.1 is met. Arm B: Patients randomized to Arm B will receive Pirtobrutinib 200 mg orally once daily.

(BASEC)

Malattie studiate

Relapsed and/or refractory (R/R) chronic lymphocytic leukemia (CLL) or small cell lymphocytic lymphoma (SLL)

(BASEC)

Criteri di partecipazione

1. Confirmed diagnosis of CLL or SLL requiring treatment according to iwCLL 2018 criteria. 2. Prior treatment for CLL/SLL with a covalent Bruton tyrosine kinase inhibitor (cBTKi). Patients should have relapsed or been refractory after at least one prior line of therapy, including treatment with a covalent BTK inhibitor (cBTKi). For patients with SLL, there must be measurable disease defined by computed tomography/magnetic resonance imaging as ≥ 1 lymph node with a diameter of > 1.5 cm in the longest dimension and measurable in 2 perpendicular diameters.

(BASEC)


Criteri di esclusione

1. Known prolymphocytic leukemia, history of prolymphocytic leukemia, or current suspicion of Richter transformation. 2. Current or prior central nervous system involvement by CLL/SLL, including brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy). 3. History of ischemic stroke or intracranial hemorrhage within months prior to the first dose of the study drug. 4. Prior treatment with a protein degrader of Bruton tyrosine kinase (BTK) or non-covalent BTK inhibitor (ncBTKi). Patients who discontinued treatment with cBTKi solely due to toxicity are not eligible. 5. History of a known bleeding disorder such as hemophilia A, hemophilia B, or von Willebrand disease, or history of spontaneous bleeding that required a blood transfusion or other medical intervention.

(BASEC)

Luogo dello studio

Berna, Zurigo

(BASEC)

non disponibile

Sponsor

BeOne Medicines I GmbH Aeschengraben 27 CH-4051 Basel, Switzerland

(BASEC)

Contatto per ulteriori informazioni sullo studio

Persona di contatto in Svizzera

Ivana Murfuni

+18778285568

clinicaltrials@beonemed.com

BeOne Medicines I GmbH

(BASEC)

Informazioni scientifiche

non disponibile

Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)

Commissione etica Zurigo

(BASEC)

Data di approvazione del comitato etico

30.01.2026

(BASEC)


ID di studio ICTRP
non disponibile

Titolo ufficiale (approvato dal comitato etico)
A Phase 3, Open-Label, Randomized Trial to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (BASEC)

Titolo accademico
non disponibile

Titolo pubblico
non disponibile

Malattie studiate
non disponibile

Intervento studiato
non disponibile

Tipo di studio
non disponibile

Disegno dello studio
non disponibile

Criteri di inclusione/esclusione
non disponibile

non disponibile

Endpoint primari e secondari
non disponibile

non disponibile

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
non disponibile

Contatti aggiuntivi
non disponibile

ID secondari
non disponibile

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
non disponibile

Risultati dello studio

Riepilogo dei risultati

non disponibile

Link ai risultati nel registro primario

non disponibile