NCT06243458

RVU120 for Treatment of Anemia in Patients With Lower-risk Myelodysplastic Neoplasms

A Phase II, Open-label, Multicenter Study of Orally Administered RVU120 for the Treatment of Anemia in Patients With Lower-risk Myelodysplastic Neoplasms (MDS)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: GCP-Service International West GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate orally administered RVU120, a novel small molecule Cyclin-dependent Kinase (CDK) 8/19 inhibitor, in terms of erythroid hematologic improvement (HI-E) and safety in participants with lower-risk myelodysplastic syndrome (MDS). Responding patients are eligible to continue treatment until loss of response/disease progression.

Conditions

• Low Risk Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	RVU120 (SEL120)	RVU120 will be taken orally every other day (q.o.d). in a 21-day treatment cycle. Doses of RVU120 will be administered from day 1 to day 13 (total of 7 doses per cycle).

Timeline

• Start date: 2024-09-10
• Primary completion: 2026-05-01
• Completion: 2027-05-01
• First posted: 2024-02-06
• Last updated: 2025-05-22

Locations

25 sites across 5 countries: France, Germany, Italy, Poland, Spain