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
Key facts
- Where
- Bonn, Cottbus, Erlangen, Flensburg, Goettingen, Greifswald, Hamburg, Hannover, Kassel, Landshut, Leipzig, Magdeburg, Mannheim, Meschede, Moenchengladbach, Muenster, Munich, Oberhausen, Rostock, Saarbrücken, Trier és Tuebingen, NémetországSee the 24 sites
- Phase
- 2. fázis
Where in Németország
- Universitaetsklinikum Bonn AöRBonn, NémetországNo longer taking part
- Carl-Thiem-Klinikum Cottbus gGmbHCottbus, NémetországNo longer taking part
- OncoSearch Institut für klinische Studien GbRErlangen, NémetországNo longer taking part
- St. Franziskus Hospital FlensburgFlensburg, NémetországNo longer taking part
- Universitaetsmedizin GoettingenGoettingen, NémetországNo longer taking part
- Universitaetsmedizin Greifswald KöRGreifswald, NémetországNo longer taking part
- OncoResearch Lerchenfeld GmbHHamburg, NémetországNo longer taking part
- Onkologie am Raschplatz Dr. Ingo Zander & Dr. Eyck von der HeydeHannover, NémetországNo longer taking part
- Klinikum Kassel GmbHKassel, NémetországNo longer taking part
- VK&K Studien GbRLandshut, NémetországNo longer taking part
- Universitaet LeipzigLeipzig, NémetországNo longer taking part
- Universitaetsklinikum Magdeburg AöRMagdeburg, NémetországNo longer taking part
- Mannheimer Onkologie PraxisMannheim, NémetországNo longer taking part
- Universitaetsklinikum Mannheim GmbHMannheim, NémetországNo longer taking part
- Klinikum Hochsauerland GmbHMeschede, NémetországNo longer taking part
- Kliniken Maria Hilf GmbH MoenchengladbachMoenchengladbach, NémetországNo longer taking part
- Universitaetsklinikum Muenster AöRMuenster, NémetországNo longer taking part
- Haematologie und Onkologie Muenchen-Pasing MVZ GmbHMunich, NémetországNo longer taking part
- Klinikum rechts der Isar der TU Muenchen AöRMunich, NémetországNo longer taking part
- Onkologie/Haematologie Rhein Ruhr Dr. med. Steiniger und Schneider Partnerschaft von AerztenOberhausen, NémetországNo longer taking part
- Zentrum Fuer Innere MedizinRostock, NémetországNo longer taking part
- Praxis für Hämatologie und OnkologieSaarbrücken, NémetországNo longer taking part
- Klinikum Mutterhaus der Borromaeerinnen gGmbHTrier, NémetországNo longer taking part
- Universitaetsklinikum Tuebingen AöRTuebingen, NémetországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universitaet Leipzig
- Trial code
- EU 2024-516438-36-00
- Record updated
- 2026. július 9.
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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.
Exclusion: Prior allogeneic or autologous stem cell transplant; Prior ESA treatment; Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding; Secondary MDS; ECOG > 2.