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Low Risk Myelodysplastic SyndromesPhase 2(MDS)NCT06243458

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

A Phase 2 study testing RVU120 (SEL120) in people with Low Risk Myelodysplastic Syndromes, run by GCP-Service International West GmbH at 25 sites in 5 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Low Risk Myelodysplastic Syndromes
What is being tested?
RVU120 (SEL120)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
25 sitesin 5 countries
Study dates
10 Sep 2024to May 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent provided prior to any study-related procedure
  • Age ≥18 years
  • Diagnosis of de novo myelodysplastic neoplasms (MDS) according to World Health Organization (WHO) 2022 criteria.
  • Diagnosis will be confirmed during screening assessment.
  • Very low, low or intermediate risk disease MDS with up to 3.5 points according to International Prognostic Scoring System Score Revised (IPSS-R) classification (to be confirmed during screening assessment).
  • Patients with del(5q) and max. one further abnormality (excluding monosomy 7, del(7q), TP53mut) are eligible.
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  • Symptomatic anemia: Symptomatic anemia (all non transfusion dependent (NTD), low transfusion burden (LTB), or high transfusion burden (HTB)) has to be documented in the 16 weeks baseline period ending on the day of inclusion.
  • Patients should be registered only if it is expected at time of registration that
  • a valid and complete Hb (at least five measurements in the period of 16 weeks before the first dose of IMP) and transfusion history will be available at inclusion AND
  • the Hb Mean over the baseline period will be less than 10 g/dL OR three or more red blood cell (RBC)-transfusions will have been given during the baseline period documenting transfusion dependence.
  • No available option of an approved MDS therapy according to decision of the treating physician and based on the following:
  • Patients must be
  • ESA exposed (and refractory or intolerant) or ESA naïve and serum erythropoietin level >200 U/L AND/OR
  • Luspatercept exposed (and refractory or intolerant) or luspatercept naïve and not eligible for treatment (e.g. not approved) AND/OR
  • Lenalidomide exposed (and refractory or intolerant) or lenalidomide naïve and not eligible for treatment (e.g. due to non-presence of del(5q))
  • Eastern Cooperative Oncology Group (ECOG) performance score of 0-2
  • Patients must have been off anti-cancer treatment for 2 weeks or 5 half-lives, whichever is longer
  • Clinical laboratory parameters as follows:
  • Peripheral white blood cell (WBC) count, no upper or lower limit at screening, but must be <10 x 109/L prior to first dose of study drug
  • Platelets count >25,000/μL
  • Serum albumin ≥ 30 g/L (3.0 g/dL)
  • Normal coagulation (elevated International Normalized Ratio (INR), prothrombin time or activated partial thromboplastin time (APTT) <1.3 x ULN acceptable)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 x the upper limit of normal (ULN)
  • Total bilirubin ≤1.5 x ULN
  • Creatinine clearance ≥60 mL/min
  • Urine protein < 2+ (as measured by dipstick) or ≤1000 mg/24 hours urine
  • Adequate cardiac function confirmed by left ventricular ejection fraction (LVEF) ≥40% as per echocardiography or MUGA (Multiple Gated Acquisition) scan
  • For females of childbearing potential (FCBP), a negative serum pregnancy test must be confirmed before enrolment. FCBP must commit to use of highly effective method of contraception during study participation and until 28 weeks (6.5 months) after the last dose of study drug. Females must also refrain from donating blood or egg (ovum) during the same time-period.
  • For males, an effective barrier method of contraception must be used during study participation until 28 weeks (6.5 months) after the last dose of study drug, if the patient is sexually active with a FCBP. Males must also refrain from donating blood or sperm during the same time-period.
  • Investigator considers the patient to be suitable for participation in the clinical study by assessing that they:
  • Understand the requirements of the clinical study and can give informed consent.
  • Can comply with study medication dosing requirements and all study-related procedures and evaluations; and
  • Are not considered to be potentially unreliable and/or not cooperative
  • Has received all Coronavirus disease-19 (COVID-19) vaccinations per relevant national guidelines.

Who cannot join

  • Inability to swallow and retain oral medications.
  • Patient does not accept bone marrow sampling during screening and after the treatment.
  • Prior treatment with azacitidine (injectable or oral) or decitabine.
  • The patient medically requires treatment with the following drugs that are forbidden during the trial or was exposed to one of these 14 days before the first dose of the IMP:
  • Erythropoiesis stimulating agent (ESA) or luspatercept
  • Granulocyte colony-stimulating factor (G-CSF) and granulocyte-macrophage colony stimulating factor (GM-CSF)
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  • Lenalidomide
  • Another investigational drug or device, or approved therapy for investigational use
  • Iron chelation therapy NOTE: if therapy was initiated 56 days or more prior to the first dose of the IMP, patient can be included. Recently initiated iron chelation [< 56 days prior to registration] might influence interpretation of hematological response after start of trial medication.
  • Previous treatment with CDK8-targeted therapy(s).
  • Active central nervous system (CNS) involvement.
  • Patients who have undergone major surgery within 28 days prior to first dose of study drug.
  • Evidence of ongoing and uncontrolled systemic bacterial, fungal, or viral infection and acute inflammatory conditions (including pancreatitis)
  • Hematopoietic stem cell transplant within 120 days prior to first dose of study drug.
  • Active Grade 2-4 acute graft versus host disease (GVHD), active moderate-to-severe chronic GVHD, or requirement for systemic immunosuppressive medications for GVHD.
  • Known seropositivity or history of active viral infection with human immunodeficiency virus (HIV).
  • Ongoing significant liver disease such as cirrhosis, drug-induced liver injury, active hepatitis or chronic persistent hepatitis B and/or C:
  • Positive serologic or polymerase chain reaction (PCR) test results for acute or chronic Hepatitis B virus (HBV) infection. Patients whose HBV infection status cannot be determined by serologic test results must be negative for HBV by PCR to be eligible for study participation.
  • Acute or chronic Hepatitis C virus (HCV) infection. Patients who are positive for HCV antibody must be negative for HCV by PCR to be eligible for study participation
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RVU120 (e.g. active inflammatory bowel disease, ulcerative disease, malabsorption syndrome, short bowel syndrome, uncontrolled nausea, vomiting or diarrhea).
  • Ongoing drug-induced pneumonitis.
  • Concurrent participation in another investigational clinical trial.
  • Taking any medications, herbal supplements or other substances (including smoking) that are known to be strong inhibitors or moderate/strong inducers or sensitive substrates of CYP1A2, within less than 5 half-lives, prior to first dose of study drug. Any exception should be discussed with the Coordinating Investigator. For clarity, vaping (use of e-cigarettes) is not considered smoking.
  • Significant cardiac dysfunction defined as myocardial infarction within 12 months of first dose of study drug, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled dysrhythmias, or poorly controlled angina.
  • Currently taking drugs that are documented, in the drug package insert, to have a risk of causing prolonged QTc or torsades de pointes (TdP) within 5 half-lives, prior to first dose of study drug.
  • Any exception should be discussed with the Coordinating Investigator.
  • Personal or family history of serious ventricular arrhythmia, or QT interval corrected for heart rate (QTc) ≥470 ms.
  • Any other prior or current medical condition, intercurrent illness, surgical history, physical or electrocardiogram (ECG) findings, laboratory abnormalities, or extenuating circumstance (e.g. alcohol or drug addiction) that, in the Investigator's opinion, could jeopardize patient safety or interfere with the objectives of the study.
  • Prior history of malignancies other than Acute myeloid leukemia (AML) or MDS, unless the patient has been free of the disease for 5 years or more prior to screening. Exceptions to the ≥5-year time limit include history of the following:
  • basal cell carcinoma of the skin
  • non-metastatic squamous cell carcinoma of the skin
  • carcinoma in situ of the cervix
  • carcinoma in situ of the breast
  • carcinoma in situ of the bladder
  • incidental histological finding of prostate cancer (Tumor/Node/Metastasis [TNM] stage of T1a or T1b).
  • Pregnant or breast-feeding females

Trial locations and contacts

25 sites in 5 countries.

25 sites in 5 countries

Italy6 sites

  • AOU delle Marche

    Ancona, 60126

  • AOU Consorziale Policlinico, Università degli Studi Aldo Moro

    Bari, 70124

  • Candiolo Cancer Institute, IRCCS Fondazione del Piemonte per l'Oncologia

    Candiolo, 10060

  • AOU Careggi

    Florence, 50134

  • IRCCS Humanitas Research Hospital

    Milan

  • Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli

    Reggio Calabria, 89133

Other trials in Italy

Spain6 sites

  • Hematology Department Vall d'Hebron Institute of Oncology (VHIO)

    Barcelona, 08035

  • Hospital Universitario de León

    León, 24008

  • Hospital Universitario La Paz

    Madrid, 28046

  • Navarra university clinic

    Pamplona, 31008

  • Complejo Asistencial Universitario de Salamanca

    Salamanca, 37007

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

France5 sites

  • CHU Grenoble Alpes - Hôpital Michallon

    Grenoble, 38700

  • CHU de Nice - Hôpital l'Archet 1

    Nice, 06202

  • Hôpital Saint-Louis, Service d'Hématologie Séniors

    Paris, 75010

  • CHU de Bordeaux - Centre François Magendie - Groupe Hospitalier Sud

    Pessac, 33604

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

    Toulouse, 31059

Other trials in France

Poland5 sites

  • Samodzielny Publiczny Szpital Kliniczny im.Andrzeja Mielęckiego Śląskiego Uniwersytetu Medycznego w Katowicach

    Katowice, 40-027

  • Pratia Hematologia Sp. z o. o. , Pratia Onkologia Katowice

    Katowice, 40-519

  • Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M.Kopernika w Łodzi

    Lodz, 93-523

  • MTZ Clinical Research powered by Pratia

    Warsaw, 02-172

  • Uniwersytecki Szpital Kliniczny im.Jana Mikulacza-Radeckiego

    Wroclaw, 50-367

Other trials in Poland

Germany3 sites

  • Marien Hospital Düsseldorf

    Düsseldorf, 40479

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

    Leipzig, 04103

  • Universitätsklinikum Münster (UKM)

    Münster, 48149

Other trials in Germany

About this study

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

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.

Being tested
RVU120 (SEL120)
Keywords
CDK8/19 Inhibitor, RVU120 (SEL120), Clinical Trial, Phase II

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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).

Study groups in NCT06243458
Study groupRoleWhat they receive
Single-arm RVU120ExperimentalNot described
Receives: Drug: RVU120 (SEL120)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Response Assessment measured after 8 full Cycles of RVU120 administration. Each cycle is 21 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2024
  2. Study start10 Sep 2024
  3. Primary completionMay 2026 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06243458
Sponsor's protocol ID
REMARK_001
Other IDs
EUCT Number 2023-509947-29
Acronym
(MDS)
Status last verified
May 2025
First submitted
25 Jan 2024
Last updated
22 May 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RVU120 (SEL120) in people with Low Risk Myelodysplastic Syndromes, run by GCP-Service International West GmbH at 25 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 34 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Italy, Spain, France, Poland, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Erythroid Response (HI-E) Rate of Participants after Treatment with RVU120 (dose of 150 mg) (time frame: Response Assessment measured after 8 full Cycles of RVU120 administration. Each cycle is 21 days.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06243458.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.

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