Letzte Aktualisierung: 06.05.2026
Myelodysplastische Syndrome [D46]
KER050-MD-201
Aktive Studien
Studieninformationen
A Phase 2, Open-Label, Ascending Dose Study of KER-050 for the Treatment of Anemia
in Patients with Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes
(MDS)
Ziele
Primäres Prüfziel
Sicherheit und Verträglichkeit von Elritercept
Sekundäre Prüfziele für die Behandlungsarme:
—
Design
Design
—
Phase
II
Zentren
Multizentrisch
Datenerhebung
Prospektiv
Interventionsgruppen
Einarmig
Verblindung
Open-Label
Erkrankung
Diagnose
Myelodysplastische Syndrome [D46]
Diagnosenbeschreibung
IPSS-R very low, low, or intermediate risk
Mutation
—
Patienten
Alter
18 - 99 Jahre
Einschlusskriterien
- Diagnosis of MDS according to WHO classification that meets IPSS-R classification of very low, low, or intermediate risk disease.
- RS-positive as defined by WHO 2016 criteria OR non-RS as defined by WHO 2016 criteria.
- Relapsed, refractory, or intolerant to frontline luspatercept treatment and have not received an interceding therapy (for example, ESA)
- Requiring ≥ 2 units of RBC transfusions over 8 weeks prior to C1D1.
- EPO < 500 U/L at Baseline
Ausschlusskriterien
Diagnosis of MDS with deletion of chromosome 5q (Del5q).
Therapie
Intervention
—
Substanz
—
| Prüfplancode | KER050-MD-201 |
|---|---|
| EudraCT | - |
| Clinicaltrials.gov | NCT04419649 |
|---|---|
| ISRCTN | - |
| DRKS | - |
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)