A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS)

NCT ID: NCT04419649

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-19
• Study Completion Date: 2031-10-30

Brief Summary

The main aim of this study is to learn how safe elritercept is and how well adults with anemia associated with lower-risk MDS tolerate treatment with different doses of elritercept. Other aims are to learn how safe elritercept is by looking at how many participants have MDS that worsens during the study and learn about the effects of elritercept on anemia linked to MDS. The study will also look to learn how elritercept affects the production of healthy RBCs.

Detailed Description

Elritercept (KER-050) is a recombinant fusion protein being studied to increase red blood cell production by inhibiting the signaling of a subset of the transforming growth factor beta (TGF-ß) family of proteins.

Conditions

Myelodysplastic Syndromes; Cytopenia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1: Elritercept Cohort 1

Participants will be administered elritercept at 0.75 milligrams per kilogram (mg/kg), subcutaneous (SC) injection, every 4 weeks on Day 1 of each cycle for up to 4 cycles (each cycle = 28 days). Following the above dose regimen, participants will continue to receive elritercept, administered SC, on Day 1, every 4 weeks up to 24 cycles (each cycle = 28 days).

Group Type: EXPERIMENTAL

Elritercept

Intervention Type: DRUG

Elritercept SC injection.

Part 1: Elritercept Cohort 2

Participants will be administered elritercept at 1.5 mg/kg, SC injection, every 4 weeks on Day 1 of each cycle for up to 4 cycles (each cycle = 28 days). Following the above dose regimen, participants will continue to receive elritercept, administered SC, on Day 1, every 4 weeks up to 24 cycles (each cycle = 28 days).

Group Type: EXPERIMENTAL

Elritercept

Intervention Type: DRUG

Elritercept SC injection.

Part 1: Elritercept Cohort 3

Participants will be administered elritercept at 2.5 mg/kg, SC injection, every 4 weeks on Day 1 of each cycle for up to 4 cycles (each cycle = 28 days). Following the above dose regimen, participants will continue to receive elritercept, administered SC, on Day 1, every 4 weeks up to 24 cycles (each cycle = 28 days).

Group Type: EXPERIMENTAL

Elritercept

Intervention Type: DRUG

Elritercept SC injection.

Part 1: Elritercept Cohort 4

Participants will be administered elritercept at 3.75 mg/kg, SC injection, every 4 weeks on Day 1 of each cycle for up to 4 cycles (each cycle = 28 days). Following the above dose regimen, participants will continue to receive elritercept, administered SC, on Day 1, every 4 weeks up to 24 cycles (each cycle = 28 days).

Group Type: EXPERIMENTAL

Elritercept

Intervention Type: DRUG

Elritercept SC injection.

Part 1: Elritercept Cohort 5

Participants will be administered elritercept at 5.0 mg/kg, SC injection, every 4 weeks on Day 1 of each cycle for up to 4 cycles (each cycle = 28 days). Following the above dose regimen, participants will continue to receive elritercept, administered SC, on Day 1, every 4 weeks up to 24 cycles(each cycle = 28 days).

Group Type: EXPERIMENTAL

Elritercept

Intervention Type: DRUG

Elritercept SC injection.

Part 2: Elritercept Dose Confirmation Cohort A

Participants with ring sideroblasts (RS)-positive Myelodysplastic syndrome (MDS) who are requiring red blood cell (RBC) transfusions will be administered Elritercept at 3.75 mg/kg, SC injection, on Day 1, every 4 weeks for up to 24 cycles (each cycle = 28 days). The dose can be modified based on participant's response.

Group Type: EXPERIMENTAL

Elritercept

Intervention Type: DRUG

Elritercept SC injection.

Part 2: Elritercept Dose Confirmation Cohort B

Participants with non-RS MDS who are requiring RBC transfusions will be administered Elritercept at 3.75 mg/kg, SC injection, on Day 1, every 4 weeks for up to 24 cycles (each cycle = 28 days). The dose can be modified based on participant's response.

Group Type: EXPERIMENTAL

Elritercept

Intervention Type: DRUG

Elritercept SC injection.

Part 2: Elritercept Dose Confirmation Cohort C

Participants who are non-transfused with either RS-positive MDS or non-RS MDS will be administered Elritercept at 3.75 mg/kg, SC injection, on Day 1, every 4 weeks for up to 24 cycles (each cycle = 28 days). The dose can be modified based on participant's response.

Group Type: EXPERIMENTAL

Elritercept

Intervention Type: DRUG

Elritercept SC injection.

Experimental: Part 2: Elritercept Dose Confirmation Cohort D

Participants with chronic myelomonocytic leukemia (CMML) and anemia will be administered Elritercept at 3.75 mg/kg, SC injection, on Day 1, every 4 weeks for up to 24 cycles (each cycle = 28 days). The dose can be modified based on participant's response.

Group Type: EXPERIMENTAL

Elritercept

Intervention Type: DRUG

Elritercept SC injection.

Part 2: Elritercept Dose Confirmation Cohort E

Participants with MDS (either RS-positive or non-RS) who are requiring RBC transfusions, have iron-overload, and are receiving iron chelation therapy will be administered Elritercept at 3.75 mg/kg, SC injection, on Day 1, every 4 weeks for up to 24 cycles (each cycle = 28 days). The dose can be modified based on participant's response.

Group Type: EXPERIMENTAL

Elritercept

Intervention Type: DRUG

Elritercept SC injection.

Part 2: Elritercept Dose Confirmation Cohort F

Participants with MDS (either RS-positive or non-RS) who are requiring RBC transfusions, have iron-overload, and are not receiving iron chelation therapy will be administered Elritercept at 3.75 mg/kg, SC injection, on Day 1, every 4 weeks for up to 24 cycles (each cycle = 28 days). The dose can be modified based on participant's response.

Group Type: EXPERIMENTAL

Elritercept

Intervention Type: DRUG

Elritercept SC injection.

Part 2: Elritercept Dose Confirmation Cohort G

Participants with MDS (either RS-positive or non-RS) who require RBC transfusions and have either relapsed, become refractory to, or intolerant to frontline luspatercept treatment will be administered Elritercept at 3.75 mg/kg, SC injection, on Day 1, every 4 weeks for up to 24 cycles (each cycle = 28 days). The dose can be modified based on participant's response.

Group Type: EXPERIMENTAL

Elritercept

Intervention Type: DRUG

Elritercept SC injection.

Long-term Extension Cohort

Participants from Part 1 and 2 cohorts who may have potential benefit from continued elritercept treatment, in the opinion of the Investigator, may elect to continue in the LTE at the same dose they were being administered in Part 1 and 2, SC injection, on day 1, every 4 weeks until end of treatment (EOT) (approximately 122 months).

Group Type: EXPERIMENTAL

Elritercept

Intervention Type: DRUG

Elritercept SC injection.

Interventions

Elritercept

Elritercept SC injection.

Intervention Type: DRUG

Other Intervention Names

KER-050; TAK-226

Eligibility Criteria

Inclusion Criteria

1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local study participant privacy regulations.

2. Male or female ≥ 18 years of age, at the time of signing informed consent.

3. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (if related to anemia).

4. Females of childbearing potential and sexually active males must agree to use highly effective methods of contraception.

5. In the opinion of the Investigator, the participant is able and willing to comply with the requirements of the protocol (e.g., all study procedures, return for follow-up visits).

Participants are eligible to be included in Part 1 of the study only if all the following criteria apply:

1. Diagnosis of MDS according to WHO classification that meets International Prognostic Scoring System-Revised (IPSS-R) classification of very low, low, or intermediate risk disease.

2. Less than (<)5percent (%) blasts in bone marrow during the Pretreatment Period.

3. Peripheral blood white blood cell (WBC) count <13,000/microliter (μL) during the Pretreatment Period.

4. Anemia defined as:

1. In non-transfused participants, having received no RBC transfusions within 8 weeks, Hgb concentration ≤ 10.0 g/dL during the Pretreatment Period OR

2. In LTB participants, having received 1 to 3 units of RBCs for Hgb ≤ 9.0 g/dL within 8 weeks of the Pretreatment Period.

OR

3. In HTB participants, having received ≥ 4 units of RBCs for Hgb ≤ 9.0 g/dL within 8 weeks of the Pretreatment Period.

Participants from Part 1 are eligible to be included in Part 1 Extension of the study only if all the following criteria apply:

1. Previously completed 4 cycles of elritercept in Part 1 with no dose-limiting toxicities (DLTs).

2. Participant has the potential to benefit from administration of elritercept, in the opinion of the Investigator.

3. < 5% blasts in bone marrow.

4. Peripheral WBC count < 13,000/μL during the 28 days prior to cycle 5 day 1 (C5D1).

Participants are eligible to be included in Part 2 of the study only if all the following criteria apply:

1. Cohort A:

• Diagnosis of MDS according to WHO classification that meets IPSS-R classification of very low, low, or intermediate risk disease.
• ring sideroblast (RS)-positive as defined by WHO 2016 criteria.
• Requiring at least 2 units of RBC transfusions in the preceding 8 weeks before cycle 1 day 1 (C1D1).

2. Cohort B:

• Diagnosis of MDS according to WHO classification that meets IPSS-R classification of very low, low, or intermediate risk disease.
• Non-RS as defined by WHO 2016 criteria.
• Requiring at least 2 units of RBC transfusions in the 8 weeks before C1D1.

3. Cohort C:

• Diagnosis of MDS according to WHO classification that meets IPSS-R classification of very low, low, or intermediate risk disease.
• Has anemia, defined by Hgb ≤ 10 g/dL during the Pretreatment Period, and received no RBC transfusion in the 8 weeks before C1D1.

4. Cohort D:

• Diagnosis of CMML according to WHO classification.
• Has anemia, defined by Hgb ≤ 10 g/dL during the Pretreatment Period, and received no RBC transfusion in the 8 weeks before C1D1.
• OR
• Received at least 2 units of RBC transfusions for anemia in the 8 weeks before C1D1.

5. Cohort E:

• Diagnosis of MDS according to WHO classification that meets IPSS-R classification of very low, low, or intermediate risk disease.
• Requiring ≥ 2 units of RBC transfusions in the preceding 8 weeks before C1D1.
• Receipt of ≥ 20 units of RBC in transfusion over the participant's lifetime.
• Serum ferritin > 1000 nanograms per milliliter (ng/mL) on ≥ 2 assessments in the preceding 8 weeks before C1D1.
• Treated with stable dose of iron chelation therapy for ≥ 8 weeks prior to C1D1.

6. Cohort F:

• Diagnosis of MDS according to WHO classification that meets IPSS-R classification of very low, low, or intermediate risk disease.
• Requiring ≥ 2 units of RBC transfusions in the preceding 8 weeks before C1D1.
• Receipt of ≥ 20 units of RBC in transfusion over the participant's lifetime.
• Serum ferritin > 1000 ng/mL on ≥ 2 assessments in the preceding 8 weeks before C1D1.
• Not treated with iron chelation therapy in the preceding 8 weeks before C1D1 and not eligible to initiate iron chelation therapy in the opinion of the Investigator and in accordance with local treatment guidelines for initiation of iron chelation therapy.

7. Cohort G:

• Diagnosis of MDS according to WHO classification that meets IPSS-R classification of very low, low, or intermediate risk disease.
• RS-positive as defined by WHO 2016 criteria OR non-RS as defined by WHO 2016 criteria.
• Relapsed, refractory, or intolerant to frontline luspatercept treatment and have not received an interceding therapy (for example, erythropoiesis-stimulating agent [ESA])

• Relapsed is defined as documentation of response to luspatercept therapy and subsequent development of a need for transfusion(s).
• Refractory is defined as documentation of no response with luspatercept ≥ 1 mg/kg administered for ≥ 12 weeks duration.
• Intolerant is defined as documentation of discontinuation of luspatercept therapy due to intolerance or an AE at any time after introduction.
• Requiring ≥ 2 units of RBC transfusions over 8 weeks prior to C1D1.
• Erythropoietin (EPO) < 500 international units per liter (U/L) at Baseline.
• Last dose of luspatercept is ≥ 3 weeks and < 12 months from C1D1.

8. < 5% blasts in bone marrow assessed by bone marrow aspirate during the Pretreatment Period.

Exclusion Criteria

Participants are excluded from Part 1 of the study if any of the following criteria apply.

Medical History

1. Diagnosis of MDS with deletion of chromosome 5q (Del5q).

2. Active infection requiring parenteral antibiotic therapy within 28 days prior to C1D1 or oral antibiotics within 14 days of C1D1. Prophylactic antibiotics and/or antifungals for neutropenia are allowed.

3. Presence of uncontrolled heart disease or New York Heart Association (NYHA) Class III or IV heart failure.

4. History of drug or alcohol abuse (as defined by the Investigator) within the past 2 years.

5. History of stroke, deep venous thrombosis (DVT), or arterial embolism within 6 months prior to C1D1.

6. Major surgery within 28 days prior to C1D1. Participants must be completely recovered from any previous surgery prior to C1D1.

7. Known positive for human immunodeficiency virus (HIV), active infectious hepatitis B virus (HBV), or active infectious hepatitis C virus (HCV). Participants without known positive history of HIV, HBV, and/or HCV do not require further testing, unless testing is mandated per local guidelines.

8. Any malignancy other than MDS that has not been in remission and/or has required systemic therapy including radiation, chemotherapy, hormonal therapy, or surgery, within 1 year prior to C1D1. Diagnosis of secondary MDS (i.e., MDS known to have arisen as the result of chemical injury or treatment with chemotherapy and/or radiation for other diseases).

9. History of solid organ or hematological transplantation.

10. Presence of uncontrolled hypertension, defined as systolic blood pressure (BP) ≥ 150 mmHg or diastolic BP ≥ 100 mmHg despite adequate treatment.

11. Body mass index (BMI) ≥ 40 kilograms per meter square (kg/m^2) during the Pretreatment Period.

12. History of severe allergic or anaphylactic reaction(s) or hypersensitivity to recombinant proteins or excipients in the investigational medicinal product (IMP).

Treatment History

1. Prior treatment with azacitidine, decitabine, lenalidomide, luspatercept, or sotatercept.

2. Treatment with ESA within 56 days prior to C1D1.

3. Prior or concurrent chronic treatment with granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF).

4. Iron chelation therapy if initiated within 8 weeks prior to C1D1.

5. Vitamin B12 therapy initiated within 8 weeks prior to C1D1. Participants on stable replacement doses for ≥ 8 weeks and without concurrent vitamin B12 or folate deficiency are allowed.

6. Treatment with another investigational drug or device or approved therapy for investigational use ≤ 28 days prior to C1D1, or, if the half-life of the previous product is known, within 5 times the half-life prior to C1D1, whichever is longer.

Laboratory Exclusions (during Pretreatment Period)

1. Platelet count > 450 ✕ 10^9/L or < 30 ✕ 10^9/L.

2. Transferrin saturation < 15%.

3. Ferritin < 50 nanograms per milliliter (ng/mL).

4. Folate < 4.5 nanomoles per liter (nmol/L) (< 2.0 ng/mL).

5. Vitamin B12 < 148 picomoles per liter (pmol/L) (< 200 picograms per milliliter [pg/mL]).

6. Estimated glomerular filtration rate (GFR) < 30 milliliter per minute per 1.73 meter square (mL/min/1.73 m^2), as determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.

7. Positive for HIV.

Miscellaneous

1. Pregnant or lactating females.

2. Any other condition not specifically noted above which, in the opinion of the Investigator, would preclude the participant from participating in the study.

3. Participants who are investigational site staff members directly involved in the conduct of the trial and their immediate family members, site staff members otherwise supervised by the Investigator, or participants who are Sponsor or contract research organization (CRO) employees directly involved in the conduct of the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.

Participants from Part 1 are excluded from Part 1 Extension of the study if any of the following criteria apply.

Medical History

1. Discontinuation of IMP in Part 1 for any reason.

2. Has not completed a study visit in the past 12 months.

3. Active infection requiring parenteral antibiotic therapy within 28 days prior to C5D1 or oral antibiotics within 14 days of C5D1. Prophylactic antibiotics and/or antifungals for neutropenia are allowed.

4. Presence of uncontrolled heart disease or NYHA Class III or IV heart failure.

5. History of drug or alcohol abuse (as defined by the Investigator) within the past 2 years.

6. History of stroke, DVT, or arterial embolism within 6 months prior to C5D1.

7. Major surgery within 28 days prior to C5D1. Participants must be completely recovered from any previous surgery prior to C5D1.

8. Known positive for HIV, active infectious HBV, or active infectious HCV. Participants without known positive history of HIV, HBV, and/or HCV do not require further testing, unless testing is mandated per local guidelines.

9. Any malignancy other than MDS that has not been in remission and/or has required systemic therapy including radiation, chemotherapy, hormonal therapy, or surgery, within 1 year prior to C5D1.

10. History of solid organ or hematological transplantation.

11. Presence of uncontrolled hypertension, defined as systolic BP ≥ 150 mmHg or diastolic BP ≥ 100 mmHg despite adequate treatment.

12. BMI ≥ 40 kg/m^2 during the 28 days prior to C5D1.

Treatment History

1. Prior treatment with azacitidine, decitabine, lenalidomide, luspatercept, or sotatercept.

2. Treatment with ESA within 56 days prior to C5D1.

3. Prior or concurrent chronic treatment with G-CSF or GM-CSF.

4. Iron chelation therapy if initiated within 8 weeks prior to C5D1.

5. Vitamin B12 with treatment initiated within 8 weeks prior to C5D1. Participants on stable replacement doses for ≥ 8 weeks and without concurrent vitamin B12 or folate deficiency are allowed.

6. Treatment with another investigational drug or device or approved therapy for investigational use ≤ 28 days prior to C5D1, or, if the half-life of the previous product is known, within 5 times the half-life prior to C5D1, whichever is longer. Previous treatment with elritercept is acceptable.

Laboratory Exclusions (during Abbreviated Pretreatment Period)

1. Platelet count > 450 × 10^9/L or < 30 × 10^9/L.

2. Transferrin saturation < 15%.

3. Ferritin < 50 ng/mL.

4. Folate < 4.5 nmol/L (< 2.0 ng/mL).

5. Vitamin B12 < 148 pmol/L (< 200 pg/mL).

6. Estimated GFR < 30 mL/min/1.73 m^2, as determined by the CKD-EPI equation.

Miscellaneous

1. Pregnant or lactating females.

2. Any other condition not specifically noted above which, in the opinion of the Investigator, would preclude the participant from participating in the study.

3. Participants who are investigational site staff members directly involved in the conduct of the trial and their immediate family members, site staff members otherwise supervised by the Investigator, or participants who are Sponsor or CRO employees directly involved in the conduct of the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.

Participants are excluded from Part 2 of the study if any of the following criteria apply.

Medical History

1. Diagnosis of MDS with Del5q.

2. Diagnosis of secondary MDS (i.e., MDS known to have arisen as the result of chemical injury or treatment with chemotherapy and/or radiation for other diseases).

3. Active infection requiring parenteral antibiotic therapy within 28 days prior to C1D1 or oral antibiotics within 14 days of C1D1. Prophylactic antibiotics and/or antifungals for neutropenia are allowed.

4. Presence of the following cardiac conditions:

1. Presence of uncontrolled heart disease or NYHA Class III or IV heart failure.

2. QTcF (QT interval corrected by Fridericia's formula) > 500 msec on the screening or C1D1 electrocardiogram (ECG; mean of 3 measurements).

3. Uncontrolled clinically significant arrhythmia (participants with rate-controlled atrial fibrillation are not excluded).

4. Acute myocardial infarction or unstable angina pectoris ≤ 6 months prior to C1D1.

5. Presence of uncontrolled hypertension, defined as systolic BP ≥ 160 mmHg or diastolic BP ≥ 100 mmHg despite adequate treatment.

6. History of stroke, DVT, or arterial embolism within 6 months prior to C1D1.

7. History of drug or alcohol abuse (as defined by the Investigator) within the past 2 years.

8. Major surgery within 28 days prior to C1D1. Participants must be completely recovered from any previous surgery prior to C1D1.

9. Any malignancy other than MDS or CMML that has not been in remission and/or has required major surgery or systemic therapy including radiation, chemotherapy, targeted therapy, or hormonal therapy within 1 year prior to C1D1.

10. History of solid organ or hematological transplantation.

11. Diagnosis of hemolytic anemia, active bleeding, hemoglobinopathies, or congenital disorders as a cause of the participant's anemia.

12. NCI-CTCAE Grade ≥ 2 bleeding events within the 3 months prior to C1D1.

13. Receipt of an RBC or platelet transfusion for any reason(s) or combination of reasons other than underlying MDS within the 16 weeks prior to C1D1. If a participant requires a transfusion for an unanticipated reason during the Pretreatment Period, a prolonged screening period may be considered after discussion with the Medical Monitor.

14. Known positive for HIV, active infectious HBV with positive viral load (HBV DNA), or active infectious HCV with positive viral load (HCV RNA). Participants without known positive history of HIV, HBV, and/or HCV do not require further testing, unless testing is mandated per local guidelines.

15. BMI ≥ 40 kg/m^2.

16. History of severe allergic or anaphylactic reaction(s) or hypersensitivity to recombinant proteins or excipients in the IMP.

17. Diagnosis of cirrhosis, non-alcoholic steatohepatitis, alcoholic liver disease, hepatitis, or other liver disease (acute or chronic) meeting Child-Pugh C criteria for hepatic impairment. Participants with elevated liver enzymes are allowed if the liver enzyme elevation is suspected to be due to iron-overload or iron chelation, and other hepatic causes have been ruled out, in the opinion of the Investigator.

Treatment History

1. Prior treatment with azacitidine, decitabine, lenalidomide, or sotatercept.

2. Prior treatment with luspatercept (Cohorts A, B, C, D, E, and F only).

3. Treatment with ESA within 8 weeks prior to C1D1.

4. Prior or concurrent chronic treatment with G-CSF or GM-CSF, for reasons other than for treatment of MDS.

a. Note: Previous treatment with G-CSF or GM-CSF for MDS, which has been discontinued ≥ 8 weeks prior to C1D1 is allowed.

5. Iron chelation therapy if initiated within 8 weeks prior to C1D1. Participants on stable doses of iron chelation therapy for ≥ 8 weeks are allowed.

6. Vitamin B12 and/or folate therapy initiated within 8 weeks prior to C1D1. Participants on stable replacement doses for ≥ 8 weeks and without concurrent vitamin B12 or folate deficiency are allowed.

7. Any need to receive a prohibited medication.

8. Treatment with another investigational drug or device or approved therapy for investigational use within 8 weeks prior to C1D1, or, if the half-life of the previous product is known, within 5 times the half-life prior to C1D1, whichever is longer.

Laboratory Exclusions (during Pretreatment Period)

1. Peripheral WBC count ≥ 13,000/μL.

2. Platelet count > 450 × 10^9/L or < 25 × 10^9/L.

3. Transferrin saturation < 15%.

4. Ferritin < 50 ng/mL.

5. Folate < 4.5 nmol/L (< 2.0 ng/mL).

6. Vitamin B12 < 148 pmol/L (< 200 pg/mL).

7. Estimated GFR < 30 mL/min/1.73 m^2 as determined by the CKD-EPI equation.

Miscellaneous

1. Pregnant or lactating females.

2. Any other condition not specifically noted above which, in the opinion of the Investigator, would preclude the participant from participating in the study.

3. Participants who are investigational site staff members directly involved in the conduct of the trial and their immediate family members, site staff members otherwise supervised by the Investigator, or participants who are Sponsor or CRO employees directly involved in the conduct of the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.

For Cohort G ONLY:

1. Any luspatercept related AE Grade ≥ 3 that has not resolved to baseline or Grade ≤ 1.

2. No history of allergy/anaphylaxis/hypersensitivity to luspatercept.

3. No prior treatment with imetelstat.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

City of Hope National Medical Center

Duarte, California, United States

Site Status: RECRUITING

University of Miami School of Medicine Sylvester Comprehensive Cancer Center (SCCC)

Miami, Florida, United States

Site Status: RECRUITING

H. Lee Moffitt Cancer Center and Research Center

Tampa, Florida, United States

Site Status: RECRUITING

Karmanos Cancer Institute at Mclaren Greater Lansing

Lansing, Michigan, United States

Site Status: COMPLETED

University of Pittsburgh Medical Health Center

Pittsburgh, Pennsylvania, United States

Site Status: ACTIVE_NOT_RECRUITING

Border Medical Oncology Research

Albury, New South Wales, Australia

Site Status: RECRUITING

Tweed Hospital

Tweed Heads, New South Wales, Australia

Site Status: RECRUITING

Westmead Hospital

Westmead, New South Wales, Australia

Site Status: RECRUITING

Townsville University Hospital

Douglas, Queensland, Australia

Site Status: COMPLETED

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Site Status: RECRUITING

Flinders Medical Centre

Bedford Park, South Australia, Australia

Site Status: RECRUITING

Boxhill Hospital

Box Hill, Victoria, Australia

Site Status: RECRUITING

University Hospital Geelong

Geelong, Victoria, Australia

Site Status: RECRUITING

Austin Health

Heidelberg, Victoria, Australia

Site Status: RECRUITING

Royal Melbourne Hospital

Melbourne, Victoria, Australia

Site Status: RECRUITING

St Vincent's Hospital Melbourne

Melbourne, Victoria, Australia

Site Status: RECRUITING

Ballarat Oncology & Haematology Service

Wendouree, Victoria, Australia

Site Status: COMPLETED

Fakultni nemocnice Brno

Brno, , Czechia

Site Status: COMPLETED

Fakultni nemocnice Kralovske Vinohrady

Prague, , Czechia

Site Status: RECRUITING

Vseobecna Fakultni Nemocnice Praha

Prague, , Czechia

Site Status: COMPLETED

CHU Angers - Hopital Hotel Dieu

Angers, , France

Site Status: COMPLETED

Centre Hospitalier de la Region dAnnecy

Épagny, , France

Site Status: COMPLETED

CHU de Nantes - Hotel Dieu

Nantes, , France

Site Status: RECRUITING

CHU Nice - Hopital de l'Archet 1

Nice, , France

Site Status: RECRUITING

Hopital Saint-Louis

Paris, , France

Site Status: RECRUITING

CH Rene-Dubos

Pontoise, , France

Site Status: RECRUITING

CHU de Bordeaux - Hopital Haut-Leveque

Talence, , France

Site Status: RECRUITING

Klinikum Bayreuth GmbH

Bayreuth, , Germany

Site Status: RECRUITING

Charite-Campus Benjamin Franklin

Berlin, , Germany

Site Status: NOT_YET_RECRUITING

Praxis am Volkspark Berlin

Berlin, , Germany

Site Status: NOT_YET_RECRUITING

University Hospital Bonn

Bonn, , Germany

Site Status: NOT_YET_RECRUITING

Marien Hospital Dusseldorf GMBH

Düsseldorf, , Germany

Site Status: RECRUITING

Universitaetsklinikum Duesseldorf AoeR

Düsseldorf, , Germany

Site Status: COMPLETED

Klinikum Esslingen GmbH

Esslingen am Neckar, , Germany

Site Status: RECRUITING

University Hospital Halle (Saale)

Halle, , Germany

Site Status: NOT_YET_RECRUITING

Universitaetsklinikum Leipzig AoeR

Leipzig, , Germany

Site Status: COMPLETED

University Hospital Magdeburg

Magdeburg, , Germany

Site Status: NOT_YET_RECRUITING

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

Mainz, , Germany

Site Status: RECRUITING

Universitaetsmedizin Rostock

Rostock, , Germany

Site Status: COMPLETED

Sheba Medical Center - Sheba Fund for Health Services and Research

Ramat Gan, , Israel

Site Status: RECRUITING

Sourasky Medical Center - Infrastructure and Health Services Fund of the Tel Aviv Medical Center

Tel Aviv, , Israel

Site Status: COMPLETED

Middlemore Hospital

Auckland, , New Zealand

Site Status: COMPLETED

Hospital Universitario Central de Asturias

Barcelona, , Spain

Site Status: RECRUITING

Hospital Universitario Vall d'Hebron

Barcelona, , Spain

Site Status: RECRUITING

ICO l'Hospitalet - Hospital Duran i Reynals

Barcelona, , Spain

Site Status: RECRUITING

Hospital Universitario de Salamanca

Salamanca, , Spain

Site Status: RECRUITING

Hospital Universitario Virgen del Rocio

Seville, , Spain

Site Status: COMPLETED

Hospital Universitari i Politecnic La Fe

Valencia, , Spain

Site Status: RECRUITING

Countries

United States; Australia; Czechia; France; Germany; Israel; New Zealand; Spain

Central Contacts

Takeda Contact

Role: CONTACT

medinfoUS@takeda.com

+1-877-825-3327

Facility Contacts

Site Contact

Role: primary

aartz@coh.org

Site Contact

Role: primary

msekeres@med.miami.edu

Site Contact

Role: primary

Rami.Komrokji@moffitt.org

Site Contact

Role: primary

APuliyayil@bordermedonc.com.au

Site Contact

Role: primary

Alejandro.ArbelaezAcevedo@health.nsw.gov.au

Site Contact

Role: primary

john.kwan@health.nsw.gov.au

Site Contact

Role: primary

devendra.hiwase@sa.gov.au

Site Contact

Role: primary

david.ross@sa.gov.au

Site Contact

Role: primary

t.teh@alfred.org.au

Site Contact

Role: primary

HANNAH.ROSE@barwonhealth.org.au

Site Contact

Role: primary

chun.fong@austin.org.au

Site Contact

Role: primary

lynette.chee@mh.org.au

Site Contact

Role: primary

shuhying.tan@svha.org.au

Site Contact

Role: primary

cerna@fnkv.cz

Site Contact

Role: primary

alice.garnier@chu-nantes.fr

Site Contact

Role: primary

cluzeau.t@chu-nice.fr

Site Contact

Role: primary

lionel.ades@aphp.fr

Site Contact

Role: primary

riad.benramdane@ght-novo.fr

Site Contact

Role: primary

sophie.dimicoli-salazar@chu-bordeaux.fr

Site Contact

Role: primary

alexander.kiani@klinikum-bayreuth.de

Site Contact

Role: primary

Site Contact

Role: primary

Site Contact

Role: primary

Site Contact

Role: primary

aristoteles.giagounidis@vkkd-kliniken.de

Site Contact

Role: primary

s.wessendorf@klinikum-esslingen.de

Site Contact

Role: primary

Site Contact

Role: primary

Site Contact

Role: primary

daniel.sasca@unimedizin-mainz.de

Site Contact

Role: primary

Drorit.Merkel@sheba.health.gov.il

Site Contact

Role: primary

bernalmaria@uniovi.es

Site Contact

Role: primary

dvalcarcelct@vhio.net

Site Contact

Role: primary

marnan@iconcologia.net

Site Contact

Role: primary

mdiezcampelo@usal.es

Site Contact

Role: primary

sanz_gui@gva.es

Other Identifiers

2023-507469-24-00

Identifier Type: CTIS

Identifier Source: secondary_id

KER050-MD-201

Identifier Type: -

Identifier Source: org_study_id