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Myelodysplastic SyndromesPhase 2LENNONNCT05384691

Efficacy of Luspatercept in ESA-naive LR-MDS Patients With or Without Ring Sideroblasts Who do Not Require Transfusions

A Phase 2 study testing Luspatercept Injection in people with Myelodysplastic Syndromes and Anemia, run by University of Leipzig at 22 sites in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Anemia in patients with very low, low or intermediate risk myelodysplastic syndromes (MDS), that are non-transfusion dependent Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myelodysplastic Syndromes, Anemia
What is being tested?
Luspatercept Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
213 participants
Where
22 sitesGermany
Study dates
27 Sep 2022to 31 Jul 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • Symptomatic anemia
  • Age > 18 years
  • Written informed consent

Who cannot join

  • 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 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.
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  • 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.

Trial locations and contacts

22 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Anne Sophie Kubasch, Dr. contact

+49 341 97-13050

annesophie.kubasch@medizin.uni-leipzig.de

Uwe Platzbecker, Prof. Dr. contact

uwe.platzbecker@medizin.uni-leipzig.de

22 sites in 1 country

Germany22 sites, 15 recruiting

  • Praxis für Hämatologie und Onkologie Berlin-Mitte

    Berlin, 10117

    Stephan Fuhrmann, Dr.

    Not yet recruiting

  • Universitätsklinikum Bonn

    Bonn, 53127

    Karin Mayer, Dr.

    Recruiting

  • Carl-Thiem-Klinikum Cottbus gGmbH

    Cottbus, 03048

    Maximilian Desole, Dr.

    Recruiting

  • OncoSearch Institut für klinische Studien GbR

    Erlangen, 91052

    Babette Häcker, Dr.

    Not yet recruiting

  • Universitätsmedizin Greifswald Klinik Innere Medizin C / Hämatologie und Onkologie

    Greifswald, 17475

    Florian Heidel, Prof. Dr.

    Not yet recruiting

  • OncoResearch Lerchenfeld GmbH

    Hamburg, 22081

    Thomas Wolff, Dr.

    Not yet recruiting

  • Klinikum Kassel GmbH Klinik für Hämatologie, Onkologie und Immunologie

    Kassel, 34125

    Active, not recruiting

  • InVO Institut für Versorgungsforschung in der Onkologie GbR

    Koblenz, 56068

    Christoph Lutz, PD Dr.

    Not yet recruiting

  • VK&K Studien GbR

    Landshut, 84036

    Florian Kaiser, PD Dr.

    Recruiting

  • Universität Leipzig - Medizinische Fakultät Klinik und Poliklinik für Hämatologie, Zelltherapie und Hämostaseologie

    Leipzig, 04103

    Anne Sophie Kubasch, Dr.

    Recruiting

  • Mannheimer Onkologie Praxis

    Mannheim, 68161

    Active, not recruiting

  • Universitätsklinikum Mannheim, III Medizinische Klinik - Hämatologie und Internistische Onkologie

    Mannheim

    Daniel Nowak, Prof.

    Not yet recruiting

  • Klinikum Hochsauerland GmbH

    Meschede, 59870

    Active, not recruiting

  • Kliniken Maria Hilf GmbH Klinik für Hämatologie, Onkologie und Gastroenterologie

    Mönchengladbach, 41063

    Active, not recruiting

  • Gemeinschaftspraxis Häamto-Onkologie

    München, 81241

    Matthias Zingerle, Dr.

    Recruiting

  • Klinikum rechts der Isar der TU München III. Medizinische Klinik - Hämatologie und Onkologie

    München, 81675

    Katharina Götze, Prof. Dr.

    Recruiting

  • Universitätsklinikum Münster, Medizinische Klinik A

    Münster

    Jan-Henrik Mikesch, PD Dr.

    Not yet recruiting

  • Studiengesellschaft Onkologie Rhein/RuhrPraxis für Hämatologie und Onkologie Oberhausen und Düsseldorf

    Oberhausen, 46145

    Active, not recruiting

  • Universitätsmedizin Rostock Klinik III (Hämatologie, Onkologie, Palliativmedizin) Zentrum für Innere Medizin

    Rostock, 18057

    Christoph Wittke, Dr.

    Not yet recruiting

  • Praxis ONKOSAAR Praxis für Hämatologie und Onkologie

    Saarbrücken, 66113

    Active, not recruiting

  • Klinikum Mutterhaus

    Trier, 54290

    Active, not recruiting

  • Universitätsklinikum Tübingen Medizinische Klinik II, AML/ALL/MDS

    Tübingen, 72076

    Maximilian Christopeit, PD Dr.

    Recruiting

Other trials in Germany

About this study

Official title: 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

Anemia in patients with very low, low or intermediate risk myelodysplastic syndromes (MDS), that are non-transfusion dependent

Read the detailed description

Patients with very low, low or intermediate risk myelodysplastic syndromes (MDS) presenting with anemia, transfusion independence (NTD) and naive towards ESA treatment

Being tested
Luspatercept Injection
Keywords
MDS, Anemia, Ring sideroblast, Low risk, non-transfusion dependence (NTD)
Medical subject headings
Myelodysplastic Syndromes, Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Luspatercept InjectionDrug

    Also called LUS

    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.

Study groups in NCT05384691
Study groupRoleWhat they receive
LuspaterceptOtherSingle-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.
Receives: Drug: Luspatercept Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Erythroid response (HI-E)

    To evaluate the proportion of patients who have an erythroid response (HI-E) according to the modified IWG 2018 criteria separately for four different clinical situations (cohorts) distinguished by two factors: Serum erythropoietin (sEPO) level AND Ring sideroblast (RS) status

    Measured: At the end of cycle 8 (each cycle is 21 days)

Secondary outcomes (7)

  1. HI-E response (erythroid response) duration

    To evaluate HI-E response from the first day of response until loss of response.

    Measured: From the date of treatment start until date of documented loss of response, assessed up to 18 months.]

  2. Time to HI-E (erythroid response)

    To evaluate the time between start of treatment and first day of response.

    Measured: From the date of treatment start until first day of response, assessed up to end of cycle 8 (each cycle is 21 days)

  3. Neutrophil (HI-N) responses

    Neutrophil (HI-N) responses according to IWG 2018 criteria

    Measured: At the end of cycle 8 (each cycle is 21 days)

  4. Platelet (HI-P) responses

    Platelet (HI-P) responses according to IWG 2018 criteria

    Measured: At the end of cycle 8 (each cycle is 21 days)

  5. Safety of luspatercept (toxicities and adverse events)

    Assessments will include characterization of toxicities; characterization of AEs including type, incidence, severity, seriousness, and relationship to treatment

    Measured: From the date of treatment start until the end of study, assessed up to 48 months

  6. Impact of treatment assessed by using the validated European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire (EORTC QLQ-C30)

    To assess patient-reported quality of life during luspatercept treatment: 30 questions assessing the quality of life of oncology patients across 10 subscales will be analyzed. All subscales have a score range from 0 to 100 points.

    Function subscales: a higher score represents a higher quality of life. Symptoms subscales: higher score represents higher level of symptoms/problems, i.e., represents lower quality of life.

    Measured: From the date of treatment start until the end of study, assessed up to 48 months.

  7. Impact of luspatercept on quality of life by using the validated Quality of Life in Myelodysplasia Scale (QUALMS)

    QoL assessment using the QUALMS questionnaire up to end of treatment:

    38-item assessment tool for patients with Myelodysplastic Syndromes (MDS) QUALMS scores ranged from 24 to 99, with higher scores for better outcome

    Measured: From the date of treatment start until the end of study, assessed up to 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2022
  2. Study start27 Sep 2022
  3. Primary completion31 Jul 2026 (estimated)
  4. Study completion31 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
213 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05384691
Sponsor's protocol ID
LENNON Trial
Acronym
LENNON
Status last verified
Jan 2024
First submitted
17 May 2022
Last updated
31 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Luspatercept Injection in people with Myelodysplastic Syndromes and Anemia, run by University of Leipzig at 22 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anne Sophie Kubasch, Dr. (+49 341 97-13050, annesophie.kubasch@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Erythroid response (HI-E) (time frame: At the end of cycle 8 (each cycle is 21 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05384691.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.

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