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Tests treatment safety and results for Myelodysplastic Syndromes
Official title Efficacy of Luspatercept in ESA-naive LR-MDS Patients With or Without Ring Sideroblasts Who do Not Require Transfusions
ClinicalTrials.gov ID: NCT05384691
What this study is testing
What is Luspatercept Injection?
Luspatercept Injection is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for myelodysplastic syndromes.
Also referred to as LUS.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Anemia in patients with very low, low or intermediate risk myelodysplastic syndromes (MDS), that are non-transfusion dependent
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosis of myelodysplastic syndrome (MDS) according to WHO classification
- 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
You likely can't join if
- Patient does not accept bone marrow sampling during screening and during treatment
- 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...
- 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...
See the full eligibility criteria
- Diagnosis of myelodysplastic syndrome (MDS) according to WHO classification
- 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
- Patient does not accept bone marrow sampling during screening and during treatment
- 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...
- 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.
- people 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)...
- 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...
- 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 people on a stable or decreasing dose for ≥ 1 week...
- Pregnant or breastfeeding females
- Positive pregnancy test in women of childbearing potential.
- Female people 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 people 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 treatment trials.
- Patients under legal supervision or guardianship.
The study team makes the final eligibility decision.
Where it's taking place
- Berlin, Germany
- Bonn, Germany
- Cottbus, Germany
- Erlangen, Germany
- Greifswald, Germany
- Hamburg, Germany
- Kassel, Germany
- Koblenz, Germany
- Landshut, Germany
- Leipzig, Germany
- Mannheim, Germany
- Meschede, Germany
- Mönchengladbach, Germany
- München, Germany
- Münster, Germany
- Oberhausen, Germany
- Rostock, Germany
- Saarbrücken, Germany
- Trier, Germany
- Tübingen, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Berlin, Germany; Bonn, Germany; Cottbus, Germany; Erlangen, Germany; Greifswald, Germany; Hamburg, Germany and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.