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2024-516438-36-00Active, not recruitingPhase 2

A phase II, open-label, single arm study to evaluate the efficacy of Luspatercept in Erythropoiesis-stimulating agent naive lower-risk MDS patients with or without ring sideroblasts who do not require RBC transfusions

A phase II, open-label, single arm study to evaluate the efficacy of Luspatercept in Erythropoiesis-stimulating agent naive lower-risk MDS patients with or without ring sideroblasts who do not require RBC transfusions (LENNON)

Source: EU CTIS (euclinicaltrials.eu) · Last updated 9 Jul 2026

Next steps

Brief summary (registry, in English)

To evaluate the erythroid response (hematologic improvement erythroid, HI-E) rate of luspatercept (LUS) for the treatment of anemia due to very low-, low-, or intermediate-risk MDS in subjects who require no RBC transfusions.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
30 (estimated)
First submitted
5 Aug 2024
Start date
13 Sept 2022
Lead sponsor
Universitaet Leipzig
EU CT number
2024-516438-36-00
EudraCT number
2020-005219-30

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 30
  • 24 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior allogeneic or autologous stem cell transplant
  • Prior ESA treatment

Other illness

  • Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding

Other

  • Secondary MDS
  • ECOG > 2

Who the study is looking for

  • Diagnosis of MDS according to WHO classification
  • Very low-, low-, or intermediate-risk disease with up to 3.5 score points according to revised International Prognostic Scoring System (IPSS-R) classification
  • Non-transfusion dependence (NTD) according to IWG 2018
  • Symptomatic anemia: mean baseline Hb < 10 g/dL

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (24)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Universitaetsklinikum Bonn AöRBonnGermanyActive, not recruiting
Carl-Thiem-Klinikum Cottbus gGmbHCottbusGermanyActive, not recruiting
OncoSearch Institut für klinische Studien GbRErlangenGermanyActive, not recruiting
St. Franziskus Hospital FlensburgFlensburgGermanyActive, not recruiting
Universitaetsmedizin GoettingenGoettingenGermanyActive, not recruiting
Universitaetsmedizin Greifswald KöRGreifswaldGermanyActive, not recruiting
OncoResearch Lerchenfeld GmbHHamburgGermanyActive, not recruiting
Onkologie am Raschplatz Dr. Ingo Zander & Dr. Eyck von der HeydeHannoverGermanyActive, not recruiting
Klinikum Kassel GmbHKasselGermanyActive, not recruiting
VK&K Studien GbRLandshutGermanyActive, not recruiting
Universitaet LeipzigLeipzigGermanyActive, not recruiting
Universitaetsklinikum Magdeburg AöRMagdeburgGermanyActive, not recruiting
Universitaetsklinikum Mannheim GmbHMannheimGermanyActive, not recruiting
Mannheimer Onkologie PraxisMannheimGermanyActive, not recruiting
Klinikum Hochsauerland GmbHMeschedeGermanyActive, not recruiting
Kliniken Maria Hilf GmbH MoenchengladbachMoenchengladbachGermanyActive, not recruiting
Universitaetsklinikum Muenster AöRMuensterGermanyActive, not recruiting
Haematologie und Onkologie Muenchen-Pasing MVZ GmbHMunichGermanyActive, not recruiting
Klinikum rechts der Isar der TU Muenchen AöRMunichGermanyActive, not recruiting
Onkologie/Haematologie Rhein Ruhr Dr. med. Steiniger und Schneider Partnerschaft von AerztenOberhausenGermanyActive, not recruiting
Zentrum Fuer Innere MedizinRostockGermanyActive, not recruiting
Praxis für Hämatologie und OnkologieSaarbrückenGermanyActive, not recruiting
Klinikum Mutterhaus der Borromaeerinnen gGmbHTrierGermanyActive, not recruiting
Universitaetsklinikum Tuebingen AöRTuebingenGermanyActive, not recruiting

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This page is information, not medical advice. Discuss any trial with your doctor.