Letzte Aktualisierung: 06.05.2026
Chronische lymphatische Leukämie (CLL) [C91.1]
BGB-16673-304
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
Ziele
Primäres Prüfziel
Progressionsfreies Überleben
Sekundäre Prüfziele für die Behandlungsarme:
Gesamtüberleben
Design
Design
Phase
Zentren
Datenerhebung
Interventionsgruppen
Verblindung
Erkrankung
Diagnose
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
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
| Prüfplancode | BGB-16673-304 |
|---|---|
| EudraCT | - |
| Clinicaltrials.gov | NCT06973187 |
|---|---|
| ISRCTN | - |
| DRKS | - |
Zuständige Gesamtstudie
—
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)




