Letzte Aktualisierung: 06.05.2026

Chronische lymphatische Leukämie (CLL) [C91.1]

BGB-16673-304

Aktive Studien

Studieninformationen

Eine offene, randomisierte Phase-III-Studie zur Beurteilung der Sicherheit und Wirksamkeit von BGB-16673 im Vergleich zu Pirtobrutinib bei Patienten mit rezidivierender/refraktärer chronischer lymphatischer Leukämie oder kleinzelligem lymphozytischem Lymphom

Behandlungszentren im CIO

Bonn


Ziele

Primäres Prüfziel

Progressionsfreies Überleben

Sekundäre Prüfziele für die Behandlungsarme:

Gesamtüberleben


Design

Design

Phase

III

Zentren

Multizentrisch

Datenerhebung

Prospektiv

Interventionsgruppen

Zweiarmig

Verblindung

Open-Label

Erkrankung

Diagnose

Kleinzelliges B-Zell-Lymphom [C83.0], Chronische lymphatische Leukämie (CLL) [C91.1]

Diagnosenbeschreibung

CLL or SLL, requiring treatment, based on 2018 iwCLL criteria. Patients must also

have previously received treatment for CLL or SLL with cBTKi

Mutation

Patienten

Alter

18 - 99 Jahre

Einschlusskriterien

  • Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 iwCLL criteria1.
  • Previously received treatment for CLL/SLL with a cBTKi. Patients should have disease relapsed after or refractory to at least 1 line of therapy including a cBTKi. Patients who discontinue cBTKi due solely to toxicity are not eligible  NOTE: A line of therapy is considered 2 or more consecutive cycles of a systemic anticancer regimen
  • Patients with SLL must have measurable disease by computed tomography/magnetic resonance imaging, defined as ≥ 1 lymph node > 1.5 cm in longest diameter and measurable in 2 perpendicular diameters


Ausschlusskriterien

1. Known prolymphocytic leukemia or history of, or currently suspected, Richter’s

transformation.

2. Prior autologous stem cell transplant or chimeric antigen receptor-T cell therapy in the

last 3 months.

3. Prior allogeneic stem cell transplant ≤ 6 months before the first dose of the study drug

(Note: patients who have previously received allogeneic stem cell transplant must have

no signs or symptoms of graft versus host disease and must not be receiving

immunosuppressive therapy.)

4. Patients who have a history of severe allergic reactions or hypersensitivity to the active

ingredient and excipients of study drug.

5. Patients who are unable to comply with the requirements of the protocol.

6. Current or history of central nervous system involvement including the brain, spinal cord,

leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy)

by CLL/SLL.


Therapie

Intervention

Substanz

Zuständige Gesamtstudie

Sponsor

Leiter der klinischen Prüfung (LKP)

Studiengruppen/-zentrale

Kontakt Klinische Studien

CIO Aachen: Uniklinik RWTH Aachen, +49 (0) 241 80-85490

CIO Bonn: Uniklinik Bonn, +49 (0) 228 287-16036

CIO Köln: Uniklinik Köln, +49 (0) 221 478-0

CIO Düsseldorf: Uniklinik Düsseldorf, +49 (0) 211 81-04150 (Mo-Do)