Clinical trial • Phase II • Haematology|Immunology
LUSPATERCEPT for Myelodysplastic syndromes (MDS) | Anemia due to lower-risk MDS
Phase II trial of LUSPATERCEPT for Myelodysplastic syndromes (MDS) | Anemia due to lower-risk MDS. open-label, none/not specified-controlled.
Overview
- Trial Therapeutic Area
- Haematology|Immunology
- Trial Disease
- Myelodysplastic syndromes (MDS) | Anemia due to lower-risk MDS
- Trial Stage
- Phase II
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 05-08-2024
- First CTIS Authorization Date
- 16-08-2024
Trial design
open-label, none/not specified-controlled Phase II trial across 24 sites in Germany.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 30
- Trial Duration For Participant
- 168
Eligibility
Recruits 30 No vulnerable population selected. Participants are adults; standard informed consent required from each participant. Assent not applicable..
- Vulnerable Population
- No vulnerable population selected. Participants are adults; standard informed consent required from each participant. Assent not applicable.
Inclusion criteria
- {"criterion_text":"-Diagnosis of MDS according to WHO classification\n-Very low-, low-, or intermediate-risk disease with up to 3.5 score points according to revised International Prognostic Scoring System (IPSS-R) classification\n-Non-transfusion dependence (NTD) according to IWG 2018\n-Symptomatic anemia: mean baseline Hb < 10 g/dL"}
Exclusion criteria
- {"criterion_text":"-Secondary MDS\n-Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding\n-Prior allogeneic or autologous stem cell transplant\n-ECOG > 2\n-Prior ESA treatment"}
Endpoints
Primary endpoints
- {"endpoint_text":"-The primary efficacy endpoint is erythroid response (HI-E) according to IWG 2018 criteria and defined as an increase in hemoglobin levels by at least 1.5 g/dL, persistent for at least 8 weeks over the baseline hemoglobin level (mean over 16 weeks prior to inclusion) and will be determined after 24 weeks of LUS treatment.","definition_or_measurement_approach":"Erythroid response (HI-E) is measured according to IWG 2018 criteria: increase in hemoglobin ≥1.5 g/dL, persistent for at least 8 weeks over baseline (baseline = mean over 16 weeks prior to inclusion); determined after 24 weeks of treatment with luspatercept."}
Secondary endpoints
- {"endpoint_text":"-To evaluate HI-E response duration on a time horizon of 18 months after response","definition_or_measurement_approach":"Duration of HI-E response evaluated over a time horizon of 18 months after initial response."}
Recruitment
- Planned Sample Size
- 30
- Recruitment Window Months
- 68
- Consent Approach
- Informed consent obtained using subject information and informed consent forms (multiple versions available in trial documents). Consent provided by the participant; no assent procedures specified (no paediatric population).
Geography
- Total Number Of Sites
- 24
- Total Number Of Participants
- 30
Germany
- Earliest CTIS Part Ii Submission Date
- 12-07-2024
- Latest Decision Or Authorization Date
- 17-07-2025
- Processing Time Days
- 370
- Number Of Sites
- 24
- Number Of Participants
- 30
Sites
- Site Name
- Kliniken Maria Hilf GmbH Moenchengladbach
- Department Name
- Klinik für Hämatologie, Onkologie und Gastroenterologie
- Contact Person Name
- Ullrich Graeven
- Contact Person Email
- ullrich.graeven@mariahilf.de
- Site Name
- VK&K Studien GbR
- Department Name
- VK&K Studien GbR
- Contact Person Name
- Florian Kaiser
- Contact Person Email
- dr.f.kaiser@vehling-kaiser.de
- Site Name
- Universitaetsklinikum Mannheim GmbH
- Department Name
- III. Medizinische Klinik - Hämatologie und Onkologie
- Contact Person Name
- Mohammed Lawan Abba
- Contact Person Email
- mohammed.abba@medma.uni-heidelberg.de
- Site Name
- OncoResearch Lerchenfeld GmbH
- Department Name
- Praxis
- Contact Person Name
- Thomas Wolff
- Contact Person Email
- t.wolff@oncoresearch-lerchenfeld.de
- Site Name
- Haematologie und Onkologie Muenchen-Pasing MVZ GmbH
- Department Name
- Hämatologie und Onkologie
- Contact Person Name
- Matthias Zingerle
- Contact Person Email
- zingerle@onkologie-pasing.de
- Site Name
- Onkologie/Haematologie Rhein Ruhr Dr. med. Steiniger und Schneider Partnerschaft von Aerzten
- Department Name
- Praxis für Hämatologie/Onkologie Oberhausen
- Contact Person Name
- Heike Steininger
- Contact Person Email
- heike.steiniger@onkologie-oberhausen.de
- Site Name
- Mannheimer Onkologie Praxis
- Department Name
- Onkologie Praxis
- Contact Person Name
- Manfred Hensel
- Contact Person Email
- hensel@mannheimer-onkologie-praxis.de
- Site Name
- Carl-Thiem-Klinikum Cottbus gGmbH
- Department Name
- 2. Med. Klinik
- Contact Person Name
- Maximilian Desole
- Contact Person Email
- m.desole@mul-ct.de
- Site Name
- Universitaet Leipzig
- Department Name
- Klinik und Poliklinik für Hämatologie, Zelltherapie und Hämostaseologie
- Contact Person Name
- Dominic Brauer
- Contact Person Email
- dominic.brauer@medizin.uni-leipzig.de
- Site Name
- Klinikum Kassel GmbH
- Department Name
- Klinik für Hämatologie, Onkologie und Immunologie
- Contact Person Name
- Martin Wolf
- Contact Person Email
- martin.wolf.studien@gnh.net
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Medizinische Klinik II, Hämatologie/Onkologie
- Contact Person Name
- Claudia Lengerke
- Contact Person Email
- Claudia.Lengerke@med.uni-tuebingen.de
- Site Name
- Universitaetsmedizin Goettingen
- Department Name
- Klinik für Hämatologie/Med. Onkologie
- Contact Person Name
- Hannes Treiber
- Contact Person Email
- hannes.treiber@med.uni-goettingen.de
- Site Name
- Klinikum rechts der Isar der TU Muenchen AöR
- Department Name
- III. Medizinische Klinik - Hämatologie und Onkologie
- Contact Person Name
- Katharina Goetze
- Contact Person Email
- katharina.goetze@tum.de
- Site Name
- Universitaetsklinikum Magdeburg AöR
- Department Name
- Zentrum für Innere Medizin, Klinik für Hämatologie/Onkologie
- Contact Person Name
- Katharina Engel
- Contact Person Email
- katharina.engel@med.ovgu.de
- Site Name
- Universitaetsmedizin Greifswald KöR
- Department Name
- Klinik & Poliklinik für Innere Medizin C
- Contact Person Name
- Adrian Schwarzer
- Contact Person Email
- adrian.schwarzer@med.uni-greifswald.de
- Site Name
- Klinikum Mutterhaus der Borromaeerinnen gGmbH
- Department Name
- Abteilung für Innere Medizin I (Onkologie)
- Contact Person Name
- Rolf Mahlberg
- Contact Person Email
- mahlberg@mutterhaus.de
- Site Name
- Praxis für Hämatologie und Onkologie
- Department Name
- Praxis für Hämatologie und Onkologie
- Contact Person Name
- Georg Jacobs
- Contact Person Email
- drgjacobs@onkosaar.de
- Site Name
- Universitaetsklinikum Bonn AöR
- Department Name
- Med. Klinik III / ZIM, Hämatologie/Onkologie
- Contact Person Name
- Karin Mayer
- Contact Person Email
- karin.mayer@ukbonn.de
- Site Name
- Zentrum Fuer Innere Medizin
- Department Name
- Klinik für Innere Medizin III, Hämatologie, Onkologie, Palliativmedizin
- Contact Person Name
- Frauke Theis
- Contact Person Email
- frauke.theis@med.uni-rostock.de
- Site Name
- Universitaetsklinikum Muenster AöR
- Department Name
- Innere Medizin A/Hämatologie-Onkologie
- Contact Person Name
- Jan-Henrik Mikesch
- Contact Person Email
- jan-henrik.mikesch@ukmuenster.de
- Site Name
- Onkologie am Raschplatz Dr. Ingo Zander & Dr. Eyck von der Heyde
- Department Name
- Praxis
- Contact Person Name
- Eyck von der Heyde
- Contact Person Email
- vdheyde@onkologie-am-raschplatz.de
- Site Name
- Klinikum Hochsauerland GmbH
- Department Name
- Klinik f. Hämatologie, Onkologie, Palliativmedizin, Stammzelltransplantation
- Contact Person Name
- Mohammad Wattad
- Contact Person Email
- m.wattad@klinikum-hochsauerland.de
- Site Name
- St. Franziskus Hospital Flensburg
- Department Name
- Abt. für Hämatologie, Onkologie
- Contact Person Name
- Nicolai Faber
- Contact Person Email
- nicolai.faber@malteser.org
- Site Name
- OncoSearch Institut für klinische Studien GbR
- Department Name
- Institut für Klin. Studien GbR
- Contact Person Name
- Babette Haecker
- Contact Person Email
- bhaecker@oncosearch.de
Sponsor
Primary sponsor
- Full Name
- Universitaet Leipzig
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- Reblozyl 75 mg powder for solution for injection
- Active Substance
- LUSPATERCEPT
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- SUBCUTANEOUS INJECTION
- Authorisation Status
- Authorised (EU marketing authorisation EU/1/20/1452/002)
- Maximum Dose
- 1.75 mg/kg
- Investigational Product Name
- Reblozyl 25 mg powder for solution for injection
- Active Substance
- LUSPATERCEPT
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- SUBCUTANEOUS INJECTION
- Authorisation Status
- Authorised (EU marketing authorisation EU/1/20/1452/001)
- Maximum Dose
- 1.75 mg/kg
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