Efficacy of Luspatercept in ESA-naive LR-MDS Patients With or Without Ring Sideroblasts Who do Not Require Transfusions
NCT ID: NCT05384691
Last Updated: 2024-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
213 participants
INTERVENTIONAL
2022-09-27
2027-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Assess Luspatercept in Lower-risk Myelodysplastic Syndrome Participants
NCT06045689
Study of Luspatercept for the Treatment of Anemia in Patients With Myelodysplastic Syndrome (MDS) (MK-6143-001)
NCT01749514
Extension Study to Evaluate Long-Term Effects of Luspatercept in Patients With Myelodysplastic Syndromes (MDS) (A536-05/MK-6143-003)
NCT02268383
A Study to Evaluate Luspatercept Treatment Patterns and Outcomes in Erythropoiesis-Stimulating Agents-Naïve Patients With Lower-Risk Myelodysplastic Syndromes in the United States
NCT06851065
A Study of Luspatercept (ACE-536) to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes
NCT02631070
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Luspatercept
Single-arm design: All patients are treated with 1.75 mg Luspatercept per kg body weight subcutaneously on day 1 of each 21 day cycle for up to 24 weeks and in case of response for up to 1.5 years.
Luspatercept Injection
All formally included patients will receive 1.75 mg/kg luspatercept administered subcutaneously every three weeks (on day 1 of each 21-day cycle) for a duration of 24 weeks.
Responders at the response assessment (according to HI-E) in week 25 will be further treated with 1.75 mg/kg luspatercept until loss of response for an expected maximum of 18 months.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Luspatercept Injection
All formally included patients will receive 1.75 mg/kg luspatercept administered subcutaneously every three weeks (on day 1 of each 21-day cycle) for a duration of 24 weeks.
Responders at the response assessment (according to HI-E) in week 25 will be further treated with 1.75 mg/kg luspatercept until loss of response for an expected maximum of 18 months.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Very low-, low-, or intermediate-risk disease MDS with up to 3.5 according to revised International Prognostic Scoring System (IPSS-R)
* Less than 5% blasts in bone marrow
* Peripheral blood white blood cell (WBC) count \< 13,000/μL
* sEPO levels ≤ 500 mU/mL
* Non-transfusion dependence (NTD) according to IWG 2018 criteria
* Symptomatic anemia
* Age \> 18 years
* Written informed consent
Exclusion Criteria
* Patient does not accept regular peripheral blood sampling for screening and during treatment.
* Patient does not accept subcutaneous application of LUS every three weeks
* Prior treatment for anemia associated with MDS (i.e. ESA, luspatercept), except previously treated with G-CSF/granulocyte-macrophage colony-stimulating factor (GM-CSF), both agents must be discontinued at least 4 weeks before registration
* Secondary MDS, i.e. MDS arising as the result of chemical injury or treatment with chemotherapy and/or radiation for other diseases
* Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding.
* Prior allogeneic or autologous stem cell transplant
* Prior history of AML
* Prior history of malignancies, other than MDS, unless the subject is free of the disease (including completion of any active or adjuvant treatment for prior malignancy) for ≥ 5 years.
* Major surgery within 8 weeks prior to registration.
* Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure ≥160 mmHg or of diastolic blood pressure (DBP) ≥ 100 mmHg despite adequate treatment
* Platelet count \< 30,000/μL (30 × 10\^9/L)
* Estimated glomerular filtration rate or creatinine clearance \< 40 mL/min
* Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) ≥ 3.0 × upper limit of normal (ULN)
* Alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) ≥ 3.0 × ULN
* Total bilirubin ≥ 2.0 × ULN
* Eastern Cooperative Oncology Group (ECOG) performance status \> 2
* Stroke, deep venous thrombosis, pulmonary or arterial embolism within 6 months prior to registration
* Myocardial infarction, uncontrolled angina, uncontrolled heart failure, or uncontrolled cardiac arrhythmia within 6 months prior to registration.
* Subjects with a known ejection fraction of ˂ 35%, confirmed by a local echocardiography or multigated acquisition scan (MUGA) performed within 6 months prior to registration, are excluded
* Uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment), known human immunodeficiency virus (HIV), known evidence of active infectious hepatitis B, and/or known evidence of active hepatitis C.
* History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the IMP
* Subject has any significant medical condition, laboratory abnormality, psychiatric illness, or is considered vulnerable by local regulations (e.g., imprisoned or institutionalized) that would prevent the subject from participating in the study.
* Subject has any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she participates in the study
* Subject has any condition or concomitant medication that confounds the ability to interpret data from the study.
* Use of any of the following within five weeks prior to registration are prohibited: Anticancer cytotoxic chemotherapeutic agent or treatment, Corticosteroid, except for subjects on a stable or decreasing dose for ≥ 1 week prior to inclusion for medical conditions other than MDS, Iron chelation therapy, except for subjects on a stable or decreasing dose for at least 8 weeks prior to registration, Other RBC hematopoietic growth factors (e.g. interleukin \[IL\]-3)
* Pregnant or breastfeeding females
* Positive pregnancy test in women of childbearing potential.
* Female subjects of childbearing potential unwilling to use a highly effective method of contraception for the course of the study through 90 days after the last dose of study medication.
* Male subjects with procreative capacity not willing to use a highly effective method of contraception, starting with the first dose of study therapy through 90 days after the last dose of study therapy.
* Participation in other interventional trials.
* Patients under legal supervision or guardianship.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Celgene Corporation
INDUSTRY
University of Leipzig
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Anne Sophie Kubasch
Coordinating Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Anne Sophie Kubasch, Dr.
Role: PRINCIPAL_INVESTIGATOR
University Leipzig
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Praxis für Hämatologie und Onkologie Berlin-Mitte
Berlin, , Germany
Universitätsklinikum Bonn
Bonn, , Germany
Carl-Thiem-Klinikum Cottbus gGmbH
Cottbus, , Germany
OncoSearch Institut für klinische Studien GbR
Erlangen, , Germany
Universitätsmedizin Greifswald Klinik Innere Medizin C / Hämatologie und Onkologie
Greifswald, , Germany
OncoResearch Lerchenfeld GmbH
Hamburg, , Germany
Klinikum Kassel GmbH Klinik für Hämatologie, Onkologie und Immunologie
Kassel, , Germany
InVO Institut für Versorgungsforschung in der Onkologie GbR
Koblenz, , Germany
VK&K Studien GbR
Landshut, , Germany
Universität Leipzig - Medizinische Fakultät Klinik und Poliklinik für Hämatologie, Zelltherapie und Hämostaseologie
Leipzig, , Germany
Mannheimer Onkologie Praxis
Mannheim, , Germany
Universitätsklinikum Mannheim, III Medizinische Klinik - Hämatologie und Internistische Onkologie
Mannheim, , Germany
Klinikum Hochsauerland GmbH
Meschede, , Germany
Kliniken Maria Hilf GmbH Klinik für Hämatologie, Onkologie und Gastroenterologie
Mönchengladbach, , Germany
Gemeinschaftspraxis Häamto-Onkologie
München, , Germany
Klinikum rechts der Isar der TU München III. Medizinische Klinik - Hämatologie und Onkologie
München, , Germany
Universitätsklinikum Münster, Medizinische Klinik A
Münster, , Germany
Studiengesellschaft Onkologie Rhein/RuhrPraxis für Hämatologie und Onkologie Oberhausen und Düsseldorf
Oberhausen, , Germany
Universitätsmedizin Rostock Klinik III (Hämatologie, Onkologie, Palliativmedizin) Zentrum für Innere Medizin
Rostock, , Germany
Praxis ONKOSAAR Praxis für Hämatologie und Onkologie
Saarbrücken, , Germany
Klinikum Mutterhaus
Trier, , Germany
Universitätsklinikum Tübingen Medizinische Klinik II, AML/ALL/MDS
Tübingen, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Stephan Fuhrmann, Dr.
Role: primary
Karin Mayer, Dr.
Role: primary
Maximilian Desole, Dr.
Role: primary
Babette Häcker, Dr.
Role: primary
Florian Heidel, Prof. Dr.
Role: primary
Thomas Wolff, Dr.
Role: primary
Christoph Lutz, PD Dr.
Role: primary
Florian Kaiser, PD Dr.
Role: primary
Anne Sophie Kubasch, Dr.
Role: primary
Daniel Nowak, Prof.
Role: primary
Matthias Zingerle, Dr.
Role: primary
Katharina Götze, Prof. Dr.
Role: primary
Jan-Henrik Mikesch, PD Dr.
Role: primary
Christoph Wittke, Dr.
Role: primary
Maximilian Christopeit, PD Dr.
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LENNON Trial
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.