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

NCT06243458 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2025-05-22

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Universitätsklinikum Leipzig

    collaborator OTHER

  • Saint-Louis Hospital, Paris, France

    collaborator OTHER

  • University of Florence

    collaborator OTHER

  • University of Salamanca

    collaborator OTHER

  • Medical University of Warsaw

    collaborator OTHER

  • Ryvu Therapeutics SA

    collaborator INDUSTRY

  • European Myelodysplastic Neoplasms Cooperative Group

    collaborator UNKNOWN

  • GCP-Service International West GmbH

    lead INDUSTRY

Principal Investigators

  • Uwe Platzbecker, Prof. · Universitätsklinikum Leipzig

  • Lionel Adès, Prof. · Service d'hématologie seniors Hôpital Saint-Louis, Paris

  • Valeria Santini, Prof. · University of Careggi, Italy

  • Krzysztof Mądry, Dr. · Medical University of Warsaw

  • Diez Campelo, Dr. · University of Salamanca

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-10
Primary Completion
2026-05-31
Completion
2027-05-31

Countries

  • France
  • Germany
  • Italy
  • Poland
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06243458 on ClinicalTrials.gov