Letzte Aktualisierung: 24.09.2025
Myelodysplastische Syndrome [D46]
AZALOX
Studieninformationen
Ziele
Primäres Prüfziel
Sekundäre Prüfziele für die Behandlungsarme:
Design
Design
Phase
Zentren
Datenerhebung
Interventionsgruppen
Verblindung
Erkrankung
Diagnose
Diagnosenbeschreibung
Mutation
Patienten
Alter
Einschlusskriterien
Ausschlusskriterien
Therapie
Intervention
Phase Ib: Patients will receive PXS-5505 in escalation doses of 150mg – 200mg BID for 28 days (= one treatment cycle d1-d28) in combination with azacitidine s.c. d8-12 and d15-16 in order to determine the RPTD. If no DLTs are experienced in cycle 1, patients can continue with their allocated dose for a total maximum of 6 treatment cycles @28 days corresponding to a maximum time of 24 weeks.
Phase II: Patients will receive PXS-5505 in the RPTD BID in combination with azacitidine s.c. d8-12 and d15-16 for 6 treatment cycles @28 days.
Phase Ib/II: Patient surveillance is performed by collecting and analyzing blood samples at each visit, physical examinations, collecting BM samples, and answering questionnaires about the quality of life and general health conditions.
Substanz
| Prüfplancode | - |
|---|---|
| EudraCT | 2024-517237-40-00 |
| Clinicaltrials.gov | - |
|---|---|
| ISRCTN | - |
| DRKS | - |
Zuständige Gesamtstudie
Universitätsklinikum Heidelberg
Leiter der klinischen Prüfung (LKP)—
Studiengruppen/-zentrale
III. Med. Klinik Hämatologie/Onkologie
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)