Informations générales
  • Catégorie de maladie Lymphome (BASEC)
  • État du recrutement recrutement pas encore commencé (BASEC/ICTRP)
  • Lieu de l’étude
    Berne, Zurich
    (BASEC)
  • Responsable de l'étude Ivana Murfuni clinicaltrials@beonemed.com (BASEC)
  • Source(s) de données BASEC: Importé de 21.09.2026 ICTRP: N/A
  • Date de mise à jour 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

  • Catégorie de maladie Lymphome (BASEC)
  • État du recrutement recrutement pas encore commencé (BASEC/ICTRP)
  • Lieu de l’étude
    Berne, Zurich
    (BASEC)
  • Responsable de l'étude Ivana Murfuni clinicaltrials@beonemed.com (BASEC)
  • Source(s) de données BASEC: Importé de 21.09.2026 ICTRP: N/A
  • Date de mise à jour 21.09.2026 08:00

Résumé de l'étude

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)

Intervention étudiée

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)

Maladie en cours d'investigation

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

(BASEC)

Critères de participation

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)


Critères d'exclusion

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)

Lieu de l’étude

Berne, Zurich

(BASEC)

non disponible

Sponsor

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

(BASEC)

Contact pour plus d'informations sur l'étude

Personne de contact en Suisse

Ivana Murfuni

+18778285568

clinicaltrials@beonemed.com

BeOne Medicines I GmbH

(BASEC)

Informations scientifiques

non disponible

Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)

Commission cantonale de Zurich

(BASEC)

Date d'approbation du comité d'éthique

30.01.2026

(BASEC)


Identifiant de l'essai ICTRP
non disponible

Titre officiel (approuvé par le comité d'éthique)
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)

Titre académique
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Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai

Résumé des résultats

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Lien vers les résultats dans le registre primaire

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