Direkt zum Inhalt | Direkt zur Navigation

Benutzerspezifische Werkzeuge

Sektionen
Studienregister
Sie sind hier: Startseite / Klinische Studien / Studienregister

Studienregister

BGB 3111-305

AcronymISRCTNEudraCTClinicaltrials.govDRKS
BGB-3111-3052018-001366-42NCT03734016

A Phase 3, Randomized Study of Zanubrutinib (BGB-3111) Compared with Ibrutinib in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Status: Active (Recruitment Closed)

Purpose / Objectives

Primary Outcome

  • To compare the efficacy of zanubrutinib versus ibrutinib as measured by overall Response rate determined by independent central review

Secondary Outcomes

  • To compare the efficacy of zanubrutinib versus ibrutinib as measured by:
    • Progression-free survival determined by independent central review
    • Progression-free survival determined by investigator assessment
    • Duration of response as determined by independent central review
    • Duration of response as determined by investigator assessment
    • Time to treatment failure
    • Rate of partial response with lymphocytosis or higher determined by independent
    • central review
    • Overall survival
    • Patient-reported outcomes
  • To compare the safety of zanubrutinib versus ibrutinib

Diagnosis

Patient attributes

Stage

firstline

Age

18-99

Inclusion criteria

  • Age 18 years or older
  • Confirmed diagnosis of CLL or SLL that meets the IWCLL criteria (Hallek et al 2008)
    • CLL/SLL requiring treatment as defined by at least 1 of the following criteria:

    • Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia

    • Massive (≥ 6 cm below left costal margin), progressive, or symptomatic splenomegaly

    • Massive nodes (≥ 10 cm in longest diameter), or progressive or symptomatic lymphadenopathy

    • [...]
  • Relapsed or refractory to at least 1 prior systemic therapy for CLL/SLL. A line of therapy is defined as completing at least 2 cycles of treatment of standard regimen according to current guidelines or of an investigational regimen on a clinical trial

  • Measurable disease by CT/magnetic resonance imaging (MRI). Measurable disease is defined as ≥ 1 lymph node > 1.5 cm in longest diameter and measurable in 2 perpendicular diameters

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

  • [...]

 

 

Exclusion criteria

  • Known prolymphocytic leukemia or history of, or currently suspected, Richter’s transformation (biopsy based on clinical suspicion may be needed to rule out Transformation)
  • Clinically significant cardiovascular disease including the following:

    • Myocardial infarction within 6 months before screening

    • Unstable angina within 3 months before screening

    • New York Heart Association class III or IV congestive heart failure (Appendix 4)

    • History of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, Torsades de Pointes)

    • QTcF > 480 milliseconds based on Fridericia’s formula

    • [...]
  • Prior malignancy within the past 3 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast

  • History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention

  • History of stroke or intracranial hemorrhage within 180 days before first dose of study drug

  • [...]

Trial design

  • Phase III
  • Multicenter
  • Prospective
  • Two-arm
  • Open Label

Intervention

Test Product, Dose, and Mode of Administration:

  • Zanubrutinib (160 mg twice daily) will be administered orally.

Reference Therapy, Dose, and Mode of Administration:

  • Ibrutinib (420 mg once daily) will be administered orally.

Documents (password protected)

Responsibilities in overall trial

BeiGene, Ltd.

    National Coordinating Investigator

    Prof. Dr. med. Barbara Eichhorst

    Study Sites

    Klinik I für Innere Medizin

    Study office

    • Klinisches Studienzentrum der Klinik I für Innere Medizin Köln

    Status

    Active (Recruitment Closed)

    Principal Investigator

    Prof. Dr. med. Barbara Eichhorst

    Deputy of Principal Investigator

    • Dr. med. Othman Al-Sawaf
    • Univ.-Prof. Dr. med. Michael Hallek

    Subinvestigator

    • Dr. med. Anja Jühling
    • Dr. med. Armin Tuchscherer
    • Priv.-Doz. Dr. med. Bastian von Tresckow

    Contact at Site