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Clinical Trials in France / NCT06987058
Enrolling by invitation Phase 2

RVU120 Rollover Study

NCT06987058 · tracked via the Priya Life Science France tracker
Phase
Phase 2
Started
2025-12-04
Last updated
2026-09-17

Condition(s) studied

Advanced Solid TumorsAcute Myeloid Leukaemia (AML)High-risk Myelodysplastic Syndrome

Investigational drug(s) / intervention(s)

RVU120 →Ruxolitinib →

RVU120: RVU120 is a potent, selective inhibitor of CDK8 and its paralog CDK19

Ruxolitinib: Selective inhibitor of the Janus Associated Kinases (JAKs) JAK1 and JAK2

Study summary

This is a multicenter rollover study to provide continued treatment to eligible participants previously enrolled in a RVU120 clinical study and to evaluate the safety of the treatment and record the time on treatment when continued under the same regimen as in the parent study.

To be eligible for this rollover study, participants must be continuing to benefit from their treatment, show an acceptable safety profile, and not have access to commercially available comparator anticancer therapy. Once transitioned to this study, participants will continue with their next planned dose per the regimen of their parent study.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. The participant is enrolled in a RVU120 clinical study and receiving RVU120-based treatment given alone or in combination for at least 5 cycles. 2. The participant is currently benefiting from, and expected to continue to benefit from, RVU120-based treatment according to the criteria set out in the parent study protocol and according to the judgment of the investigator and sponsor. 3. The participant does not have access to commercially available comparator anticancer therapy. 4. Contraceptive use by participants or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 5. The participant signed the rollover study ICF prior to any study-related procedure or study data collection. 6. The participant agrees not to donate blood during study participation and until 28 weeks (\~6.5 months) after the last dose. 7. The investigator considers the participant to be eligible for participation in the rollover study. Exclusion Criteria: 1. Presence of toxicity that cannot be adequately managed. 2. Concurrent participation in any therapeutic clinical study other than the parent study.

Primary outcome measure(s)

Trial sites (7)

FacilityCityRegionStatus
Hôpital l'Archet 1 - CHU de Nice; Service Hématologie Clinique Nice France
Hôpital Haut-Lévêque- CHU de Bordeaux, Centre François Magendie, Service d'Hématologie Clinique et Thérapie Cellulaire Pessac France
M2M Med Sp. Z o.o. Chorzów Poland
CWBK UCK Ośrodek Badań Klinicznych Wczesnych Faz Gdansk Poland
Pratia Hematologia Sp. z o.o. Pratia Onkologia Katowice Katowice Poland
SPZOZ Szpital Uniwersytecki w Krakowie Krakow Poland
Uniwersytecki Szpital Kliniczny-Klinika Hematologii, Terapii Komórkowych i Chorób Wewnętrznych Wroclaw Poland

On this site

📄 Jakafi (ruxolitinib) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06987058 on ClinicalTrials.gov ↗ ← All trials in France