Actively Recruiting
Efficacy of Luspatercept in ESA-naive LR-MDS Patients With or Without Ring Sideroblasts Who do Not Require Transfusions
Led by University of Leipzig · Updated on 2024-01-31
213
Participants Needed
22
Research Sites
252 weeks
Total Duration
On this page
Sponsors
U
University of Leipzig
Lead Sponsor
C
Celgene Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Anemia in patients with very low, low or intermediate risk myelodysplastic syndromes (MDS), that are non-transfusion dependent
CONDITIONS
Official Title
Efficacy of Luspatercept in ESA-naive LR-MDS Patients With or Without Ring Sideroblasts Who do Not Require Transfusions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of myelodysplastic syndrome (MDS) according to WHO classification
- Very low-, low-, or intermediate-risk MDS with IPSS-R score up to 3.5
- Less than 5% blasts in bone marrow
- Peripheral blood white blood cell (WBC) count less than 13,000/µL
- Serum erythropoietin (sEPO) levels 500 mU/mL or less
- Non-transfusion dependent according to IWG 2018 criteria
- Symptomatic anemia
- Age over 18 years
- Written informed consent
You will not qualify if you...
- Refusal to undergo bone marrow sampling during screening and treatment
- Refusal to undergo regular peripheral blood sampling during screening and treatment
- Refusal to accept subcutaneous luspatercept injections every three weeks
- Prior anemia treatment for MDS with ESA or luspatercept, except prior G-CSF or GM-CSF discontinued at least 4 weeks before registration
- Secondary MDS due to chemical injury, chemotherapy, or radiation
- Clinically significant anemia from iron, vitamin B12, folate deficiencies, autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding
- Prior allogeneic or autologous stem cell transplant
- Prior history of acute myeloid leukemia (AML)
- Prior malignancies other than MDS unless disease-free for 5 years or more
- Major surgery within 8 weeks before registration
- Uncontrolled hypertension despite treatment
- Platelet count less than 30,000/µL
- Estimated glomerular filtration rate or creatinine clearance less than 40 mL/min
- AST/SGOT or ALT/SGPT levels 3 times or more above normal
- Total bilirubin 2 times or more above normal
- ECOG performance status greater than 2
- Stroke, deep vein thrombosis, pulmonary or arterial embolism within 6 months before registration
- Recent severe heart conditions within 6 months
- Ejection fraction 35% or less confirmed by heart scan within 6 months
- Uncontrolled systemic infections or known HIV or active hepatitis B or C
- History of severe allergic reactions to recombinant proteins or study medication components
- Significant medical, psychiatric, or social conditions preventing study participation
- Conditions or medications confounding study data interpretation
- Use of certain treatments (anticancer chemotherapy, corticosteroids, iron chelation therapy, other hematopoietic growth factors) within specified periods before registration
- Pregnant or breastfeeding females
- Positive pregnancy test in women of childbearing potential
- Females or males of childbearing potential unwilling to use effective contraception during and 90 days after study
- Participation in other interventional trials
- Patients under legal supervision or guardianship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 22 locations
1
Praxis für Hämatologie und Onkologie Berlin-Mitte
Berlin, Germany, 10117
Not Yet Recruiting
2
Universitätsklinikum Bonn
Bonn, Germany, 53127
Actively Recruiting
3
Carl-Thiem-Klinikum Cottbus gGmbH
Cottbus, Germany, 03048
Actively Recruiting
4
OncoSearch Institut für klinische Studien GbR
Erlangen, Germany, 91052
Not Yet Recruiting
5
Universitätsmedizin Greifswald Klinik Innere Medizin C / Hämatologie und Onkologie
Greifswald, Germany, 17475
Not Yet Recruiting
6
OncoResearch Lerchenfeld GmbH
Hamburg, Germany, 22081
Not Yet Recruiting
7
Klinikum Kassel GmbH Klinik für Hämatologie, Onkologie und Immunologie
Kassel, Germany, 34125
Active, Not Recruiting
8
InVO Institut für Versorgungsforschung in der Onkologie GbR
Koblenz, Germany, 56068
Not Yet Recruiting
9
VK&K Studien GbR
Landshut, Germany, 84036
Actively Recruiting
10
Universität Leipzig - Medizinische Fakultät Klinik und Poliklinik für Hämatologie, Zelltherapie und Hämostaseologie
Leipzig, Germany, 04103
Actively Recruiting
11
Mannheimer Onkologie Praxis
Mannheim, Germany, 68161
Active, Not Recruiting
12
Universitätsklinikum Mannheim, III Medizinische Klinik - Hämatologie und Internistische Onkologie
Mannheim, Germany
Not Yet Recruiting
13
Klinikum Hochsauerland GmbH
Meschede, Germany, 59870
Active, Not Recruiting
14
Kliniken Maria Hilf GmbH Klinik für Hämatologie, Onkologie und Gastroenterologie
Mönchengladbach, Germany, 41063
Active, Not Recruiting
15
Gemeinschaftspraxis Häamto-Onkologie
München, Germany, 81241
Actively Recruiting
16
Klinikum rechts der Isar der TU München III. Medizinische Klinik - Hämatologie und Onkologie
München, Germany, 81675
Actively Recruiting
17
Universitätsklinikum Münster, Medizinische Klinik A
Münster, Germany
Not Yet Recruiting
18
Studiengesellschaft Onkologie Rhein/RuhrPraxis für Hämatologie und Onkologie Oberhausen und Düsseldorf
Oberhausen, Germany, 46145
Active, Not Recruiting
19
Universitätsmedizin Rostock Klinik III (Hämatologie, Onkologie, Palliativmedizin) Zentrum für Innere Medizin
Rostock, Germany, 18057
Not Yet Recruiting
20
Praxis ONKOSAAR Praxis für Hämatologie und Onkologie
Saarbrücken, Germany, 66113
Active, Not Recruiting
21
Klinikum Mutterhaus
Trier, Germany, 54290
Active, Not Recruiting
22
Universitätsklinikum Tübingen Medizinische Klinik II, AML/ALL/MDS
Tübingen, Germany, 72076
Actively Recruiting
Research Team
A
Anne Sophie Kubasch, Dr.
CONTACT
U
Uwe Platzbecker, Prof. Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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