Study of SEL120 Monohydrochloride for Treating Anemia in Patients with Lower-Risk Myelodysplastic Syndromes (MDS)

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What is this study about?

This clinical trial is focused on studying a condition called anemia in patients with a type of blood disorder known as myelodysplastic syndromes (MDS). These are disorders caused by poorly formed or dysfunctional blood cells. The study will use a treatment called RVU120, which is a small-molecule anticancer drug that works as a CDK8 kinase inhibitor. This drug is taken orally in the form of a capsule.

The purpose of the study is to evaluate how well RVU120 can help improve anemia in patients with lower-risk MDS. Participants in the study will receive the medication over a period of time, and their response to the treatment will be monitored. The study will look at how the drug affects the production of red blood cells and whether it can reduce the need for blood transfusions. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of RVU120.

Throughout the study, participants will have regular check-ups to monitor their health and the effects of the treatment. The study aims to gather information on the safety and effectiveness of RVU120 in treating anemia associated with MDS. This research could potentially lead to new treatment options for patients with this condition.

1 joining the study

Upon joining the study, the patient will begin by providing written informed consent. This is a necessary step before any study-related procedures can take place.

2 initial assessment

The patient will undergo an initial assessment to confirm the diagnosis of myelodysplastic neoplasms (MDS) and to ensure eligibility based on specific criteria, such as age and risk level of the disease.

3 medication administration

The patient will receive the study medication, RVU120, which is administered orally in the form of capsules. The dosage is 150 mg per cycle.

4 treatment cycles

The treatment consists of multiple cycles. Each cycle involves the administration of the medication and monitoring of the patient’s response. The primary goal is to evaluate the erythroid response, which refers to the production of red blood cells.

5 monitoring and evaluation

Throughout the study, the patient’s health and response to the medication will be closely monitored. This includes regular blood tests to measure hemoglobin levels and assess the need for red blood cell transfusions.

6 completion of treatment

After completing 8 full cycles of treatment, the patient’s response will be evaluated according to specific criteria. The study aims to determine the effectiveness of the medication in improving anemia symptoms.

7 end of study

The study is estimated to conclude by May 2027. At the end of the study, a final assessment will be conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who Can Join the Study?

You must provide written informed consent before any study-related procedures.
You must be at least 18 years old.
You must have a diagnosis of myelodysplastic neoplasms (MDS), which is a type of blood disorder, according to specific criteria.
Your MDS must be classified as very low, low, or intermediate risk, based on a scoring system used by doctors.
You must have symptomatic anemia, which means you have low red blood cell levels causing symptoms, documented in the 16 weeks before starting the study treatment.
There should be no available approved MDS therapy options for you, as decided by your doctor. This includes being exposed to certain treatments like ESA, luspatercept, or lenalidomide, or not being eligible for them.
You must have an Eastern Cooperative Oncology Group (ECOG) performance score of 0-2, which is a scale used to assess how well you can perform daily activities.
You must have stopped any anti-cancer treatment for at least 2 weeks or 5 half-lives, whichever is longer.
Your laboratory test results must meet specific criteria, such as certain levels of white blood cells, platelets, and other blood components.
Your heart function must be adequate, confirmed by a test showing a left ventricular ejection fraction of at least 40%.
If you are male and sexually active with a female who can become pregnant, you must use an effective barrier method of contraception during the study and for 28 weeks after the last dose of the study drug. You must also not donate blood or sperm during this time.
The study investigator must consider you suitable for participation, meaning you understand the study requirements, can give informed consent, and can comply with study procedures.
You must have received all COVID-19 vaccinations according to national guidelines.

Who Cannot Join the Study?

Patients who have a different type of anemia that is not related to very low, low, or intermediate risk myelodysplastic neoplasms (MDS) cannot participate.
Patients who do not meet the specific age range required for the study cannot participate.
Patients who are not part of the specific clinical trial group required for the study cannot participate.
Patients who are not able to give informed consent or are considered part of a vulnerable population may not be eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
IRCCS Humanitas Research Hospital	Rozzano	Italy
Hospital Universitario De Salamanca	Salamanca	Spain
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Universitaet Leipzig	Leipzig	Germany
Oncopole Claudius Regaud	Toulouse	France
Hospital Universitario De Navarra	Pamplona	Spain
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Mtz Clinical Research Powered By Pratia	Warsaw	Poland
Pratia Hematologia Sp. z o.o.	Katowice	Poland
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy
Marien Hospital Duesseldorf GmbH	Duesseldorf	Germany
Hospital Universitario De Leon	Leon	Spain
Universita’ Politecnica Delle Marche	Ancona	Italy
Centre Hospitalier Universitaire De Nice	Nice	France
University Hospital Consorziale Policlinico	Bari	Italy
Wrxkvwgktwu Wbhjyojcbtonxvopewyx Cssfavz Opurftgzk I Tbybyytodmjcj Ic Mcjemjboucx W Llsqu	Lodz	Poland
Abaqmftpen Psqvtqdp Hhjiioxw Dq Pbjcl	Paris	France
Aybogqy Uatbf Seozidwcv Lendyq Dk Bfbqkar	Bologna	Italy
Uezisuhnndyelh Ctfqhxb Kkgocpojz	Gdansk	Poland
Ftoaoepln Pdib Lf Idcyjylydutxw Bgetmkjae Dog Hdedacfc Uiizfghxccghi Lh Pmc	Madrid	Spain
Hwkzkvmz Vjee dezaiulf	Barcelona	Spain
Sylbiymtqkv Pvdycutet Syedoqx Ktgtlifgq Iiucwodiwxn Mvxmuxpyudw Svs W Krxkrapaoy	Katowice	Poland

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.05.2024
Germany	Not recruiting	01.05.2024
Italy	Not recruiting	01.05.2024
Poland	Not recruiting	01.05.2024
Spain	Not recruiting	01.05.2024

Trial locations

Investigated drugs:

7,8-Dibromo-5,6-Dihydro-9-Methyl-2-(1-Piperazinyl)-4H-Imidazo[4,5,1-Ij]Quinoline Hydrochloride

RVU120 is an oral medication being studied for its potential to treat anemia in patients with lower-risk myelodysplastic neoplasms (MDS). The goal of the trial is to see how well this medication can help improve the production of red blood cells in these patients.

Investigated diseases:

Myelodysplastic Neoplasms (MDS) – Myelodysplastic neoplasms are a group of disorders caused by poorly formed or dysfunctional blood cells. These conditions occur when something goes wrong in the bone marrow, where blood cells are produced. Patients with MDS often experience anemia, which is a deficiency of red blood cells, leading to fatigue and weakness. The risk level of MDS can vary, with some patients having very low to intermediate risk. Over time, MDS can lead to a decrease in the number of healthy blood cells, causing symptoms like frequent infections or easy bruising. The progression of the disease can vary, with some cases remaining stable for years, while others may progress to more severe forms.

Trial ID:

2023-509947-29-00

Protocol code:

REMARK_001

NCT ID:

NCT06243458

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of SEL120 Monohydrochloride for Treating Anemia in Patients with Lower-Risk Myelodysplastic Syndromes (MDS)

What is this study about?

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