Study Comparing Luspatercept and Epoetin Alfa for Treating Anemia in Patients with Low-Risk Myelodysplastic Syndrome Who Are Not Dependent on Blood Transfusions

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What is this study about?

This clinical trial is focused on studying a condition known as Myelodysplastic Syndrome (MDS), which is a type of blood disorder where the bone marrow does not produce enough healthy blood cells. The study aims to compare the effectiveness and safety of two treatments for anemia caused by MDS. The treatments being compared are Luspatercept, also known by its code name ACE-536, and Epoetin Alfa. Both of these treatments are designed to help increase the production of red blood cells in the body.

The purpose of the study is to see how well these treatments work in people with lower-risk MDS who are not dependent on blood transfusions. Participants in the study will receive either Luspatercept or Epoetin Alfa through injections under the skin. The study will last for a period of up to 96 weeks, during which participants will be monitored to see if they need fewer blood transfusions and if their hemoglobin levels, which measure the amount of red blood cells, improve.

Throughout the study, participants will be regularly assessed to ensure their safety and to track the effectiveness of the treatments. The study will help determine which treatment is more effective in managing anemia in patients with MDS who have not previously been treated with erythropoiesis-stimulating agents, which are medications that help the body produce more red blood cells. This research is important for improving treatment options for people living with MDS.

1 joining the study

Upon joining the study, the participant is confirmed to meet the eligibility criteria, including age, diagnosis of myelodysplastic syndrome (MDS), and transfusion independence.

The participant’s baseline hemoglobin (Hb) concentration and serum erythropoietin level are assessed to ensure they meet the study requirements.

2 randomization

The participant is randomly assigned to receive either luspatercept or epoetin alfa.

This randomization determines the treatment group for the duration of the study.

3 treatment administration

Participants in the luspatercept group receive the medication as a subcutaneous injection. The dosage is either 25 mg or 75 mg, depending on the specific requirements of the study.

Participants in the epoetin alfa group receive the medication as a subcutaneous injection. The available dosages are 2,000 IU, 4,000 IU, 6,000 IU, 20,000 IU, 30,000 IU, or 40,000 IU, administered in pre-filled syringes.

The frequency and duration of administration are determined by the study protocol and the participant’s response to treatment.

4 monitoring and assessments

Throughout the study, regular monitoring of hemoglobin levels and other health indicators is conducted to assess the participant’s response to treatment.

Participants are evaluated for any symptoms of anemia, such as fatigue, weakness, shortness of breath, or dizziness.

5 end of treatment period

The treatment period lasts up to 96 weeks, during which the primary endpoint is assessed: conversion to transfusion dependence, defined as receiving 3 or more units of red blood cells within any 16-week interval.

Secondary endpoints include achieving an increase in mean hemoglobin values from baseline by at least 1.5 g/dL in any continuous 16-week interval without transfusion.

6 study completion

Upon completion of the study, final assessments are conducted to evaluate the overall efficacy and safety of the treatment received.

Participants receive information about their treatment outcomes and any necessary follow-up care.

Who Can Join the Study?

Participant must be at least 18 years old or the local age of consent.
Participant must have a confirmed diagnosis of Myelodysplastic Syndrome (MDS), which is a type of blood disorder. The diagnosis should meet specific risk levels as determined by a test called IPSS-R. This includes very low, low, or intermediate risk, with certain conditions in the bone marrow and blood.
Participant must have a baseline level of a substance in the blood called serum erythropoietin that is 500 U/L or lower.
Participant must not need regular blood transfusions, according to specific criteria. However, 1 to 2 units of blood transfusion are allowed if they were given for an acute event like surgery, bleeding, or infection, and not just for low hemoglobin levels.
Participant must have a baseline hemoglobin (Hb) concentration of 9.5 g/dL or lower. Hemoglobin is a protein in red blood cells that carries oxygen. This level is calculated using the average of the two lowest measurements taken within 16 weeks before the study starts.
Participant must have symptoms of anemia, such as moderate or greater fatigue, weakness, shortness of breath, or dizziness, as recorded during the screening period.
Participant must have an Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2. This score is used to assess how well a person can perform daily activities.
Participant must not have used erythropoiesis-stimulating agents before, which are drugs that help the body make more red blood cells. However, if the participant has received no more than 2 doses of certain medications like epoetin alfa, and the last dose was at least 8 weeks before the study, they may still be eligible.

Who Cannot Join the Study?

Patients with a different condition than Myelodysplastic Syndrome (MDS) cannot participate. MDS is a group of disorders caused by poorly formed or dysfunctional blood cells.
Patients who are not in the age range specified for the study cannot participate. The study includes certain age groups only.
Patients who do not meet the specific health requirements set by the study cannot participate.
Patients who are not able to follow the study procedures or attend the required visits cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently may not be eligible.
Patients with certain medical conditions that could interfere with the study results cannot participate.
Patients who are taking medications that could affect the study outcomes 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
Institut Gustave Roussy	Villejuif	France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Onkologie Erding	Erding	Germany
IRCCS Humanitas Research Hospital	Rozzano	Italy
University Hospital Jena KöR	Jena	Germany
Hospital Universitario De Salamanca	Salamanca	Spain
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Universitaet Leipzig	Leipzig	Germany
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Oncopole Claudius Regaud	Toulouse	France
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
CHU Grenoble Alpes	La Tronche	France
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy

Other Sites

Site Name	City	Country
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Fakultni Nemocnice Brno	Brno	Czechia
Markhot Ferenc Oktatokorhaz Es Rendelointezet	Eger	Hungary
General University Hospital Of Patras	Patras	Greece
Centre Hospitalier Universitaire De Nice	Nice	France
University General Hospital Of Alexandroupoli	Alexandroupoli	Greece
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego	Walbrzych	Poland
Gesellschaft Zur Forderung Des Wissenschaftlich Medizinischen Erkenntnisgewinns In Der Hamatologie Und Oncologie	Munster	Germany
Semmelweis University	Budapest	Hungary
Hospital Universitario Central De Asturias	Oviedo	Spain
Pratia Hematologia Sp. z o.o.	Katowice	Poland
Grande Ospedale Metropolitano Bianchi Melacrino Morelli	Reggio Calabria	Italy
Hospital Clinico Universitario De Valencia	Valencia	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz	Nyiregyhaza	Hungary
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Mtz Clinical Research Powered By Pratia	Warsaw	Poland
Institut Fuer Versorgungsforschung In Der Onkologie GbR	Koblenz	Germany
Kliniken Ostalb gemeinnuetzige kommunale Anstalt des oeffentlichen Rechts	Mutlangen	Germany
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Haematologisch Onkologische Schwerpunktpraxis	Wuerzburg	Germany
Azienda Ospedaliera Ordine Mauriziano Di Torino	Turin	Italy
University Hospital Ostrava	Ostrava	Czechia
Aipvxdmndw Pxsrhvin Haygdlbi Dz Pknjn	Paris	France
Cvjt Dw Nihbw	Vandoeuvre Les Nancy	France
Hyfjzjkf Uvcjfmjuvzvda Dj Lf Pwlgwwbx	Madrid	Spain
Prqaiz fwf Hxtcdpwlrdk ufp Ouesrzqla Bubqxm Mjoll	Berlin	Germany
Lhnsa Ghdwhpc Hxjlkzxb Ok Auxuzc	Athens	Greece
Uydipvqlelpfvocxernrw Dpuhszipxmq Aay	Duesseldorf	Germany
Cpimdn Hkmcvxvtbjg Repiqnce Uvtsjjquysbtv Dp Tqkvz	Tours	France
Ankdtwy Udogq Sojjdalhw Lbwryr Dl Bgvalgu	Bologna	Italy
Uvdqtvwmqfjmsq Clsoarz Kertnjsii	Gdansk	Poland
Crhmez Hhgzgujrorj Rfgmudbh Duvzmcfuyzvscm	Angers	France
Hewvwiyo Vovf durcktmd	Barcelona	Spain
Uwrfuqbdwo Gkfnety Hmrcljzg Adhcooo	Athens	Greece

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	28.08.2023
France	Recruiting	28.08.2023
Germany	Not recruiting	28.08.2023
Greece	Not recruiting	28.08.2023
Hungary	Not recruiting	28.08.2023
Italy	Not recruiting	28.08.2023
Poland	Not recruiting	28.08.2023
Spain	Not recruiting	28.08.2023

Trial locations

Investigated drugs:

Luspatercept (ACE 536) is a medication being studied for its ability to treat anemia in patients with certain types of myelodysplastic syndrome (MDS). It works by helping the body produce more red blood cells, which can reduce the need for blood transfusions in patients who are not currently dependent on them.

Epoetin Alfa is a medication used to treat anemia by stimulating the bone marrow to produce more red blood cells. It is commonly used in patients with various types of anemia, including those with myelodysplastic syndrome (MDS), to help increase their red blood cell count and reduce the need for blood transfusions.

Myelodysplastic Syndrome (MDS) – Myelodysplastic Syndrome is a group of disorders caused by poorly formed or dysfunctional blood cells. It occurs when the bone marrow, which is responsible for producing blood cells, does not function properly. This leads to a shortage of one or more types of blood cells, such as red blood cells, white blood cells, or platelets. Symptoms may include fatigue, shortness of breath, easy bruising, and frequent infections. Over time, MDS can progress to more severe forms of anemia or even acute myeloid leukemia. The progression and symptoms can vary widely among individuals.

Trial ID:

2022-500430-29-00

Protocol code:

CA056-025

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Luspatercept and Epoetin Alfa for Treating Anemia in Patients with Low-Risk Myelodysplastic Syndrome Who Are Not Dependent on Blood Transfusions

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?