Trials Sponsors Conditions Drugs Pricing

Conditions

Anemia in patients with very low, low or intermediate risk myelodysplastic neoplasms (MDS)Low Risk Myelodysplastic Syndromes

Keywords

CDK8/19 InhibitorRVU120 (SEL120)Clinical Trial, Phase II

Outcome Measures

Primary Outcomes (1)

Erythroid Response (HI-E) Rate of Participants after Treatment with RVU120 (dose of 150 mg)
The International Working Group (IWG) 2018 Hematologic Improvement Criteria for MDS will be used to define responders.
Response Assessment measured after 8 full Cycles of RVU120 administration. Each cycle is 21 days.

Study Arms (1)

Single-arm RVU120

EXPERIMENTAL

Drug: RVU120 (SEL120)

Interventions

RVU120 (SEL120)Drug

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).

Single-arm RVU120

SEL120 monohydrochlorideType not reported

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Written informed consent provided prior to any study-related procedure
Age ≥18 years

Sponsors & Collaborators

GCP-Service International West GmbH
Industrylead
European Myelodysplastic Neoplasms Cooperative Group
Type not reportedcollaborator

Study Sites (25)

CHU Grenoble Alpes - Hôpital Michallon

Grenoble, 38700, France

CHU de Nice - Hôpital l'Archet 1

Nice, 06202, France

Hôpital Saint-Louis, Service d'Hématologie Séniors

Paris, 75010, France

CHU de Bordeaux - Centre François Magendie - Groupe Hospitalier Sud

Pessac, 33604, France

CHU de Toulouse - Institut Universitaire du Cancer de Toulouse - Oncopole

Toulouse, 31059, France

Marien Hospital Düsseldorf

Düsseldorf, 40479, Germany

Universität Leipzig, Med. Fak., Klinik und Poliklinik für Hämatologie, Zelltherapie, Hämostaseologie und Infektiologie

Study Officials

Uwe Platzbecker, Prof.
Universitätsklinikum Leipzig
PRINCIPAL INVESTIGATOR
Lionel Adès, Prof.
Service d'hématologie seniors Hôpital Saint-Louis, Paris
PRINCIPAL INVESTIGATOR
Valeria Santini, Prof.
University of Careggi, Italy
PRINCIPAL INVESTIGATOR
Krzysztof Mądry, Dr.
Medical University of Warsaw
PRINCIPAL INVESTIGATOR

Enrollment

41 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 25, 2024

First Posted

February 6, 2024

Study Start

September 10, 2024

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Single-arm RVU120

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (25)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source records

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Single-arm RVU120

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (25)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source records

Locations