Actively Recruiting
A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS)
Led by Takeda · Updated on 2026-02-06
160
Participants Needed
47
Research Sites
584 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand study purpose and provide informed consent
- Male or female aged 18 years or older
- ECOG performance status 0, 1, or 2 if related to anemia
- Females of childbearing potential and sexually active males must use effective contraception
- Able and willing to follow study procedures and attend follow-up visits
- Diagnosis of MDS per WHO classification with very low, low, or intermediate risk by IPSS-R
- Less than 5% bone marrow blasts before treatment
- Peripheral blood white blood cell count less than 13,000/microliter before treatment
- Anemia defined by hemoglobin levels and transfusion history within 8 weeks before treatment
- For Part 1 Extension, completed 4 cycles of elritercept with no dose-limiting toxicities
- For Part 2, specific cohorts require diagnosis of MDS or CMML with defined transfusion needs and hemoglobin levels
You will not qualify if you...
- Diagnosis of MDS with deletion of chromosome 5q (Del5q)
- Active infection requiring recent antibiotic therapy
- Uncontrolled heart disease or NYHA Class III or IV heart failure
- History of drug or alcohol abuse within past 2 years
- History of stroke, deep venous thrombosis, or arterial embolism within 6 months
- Major surgery within 28 days prior to treatment
- Known positive for HIV, active hepatitis B or C infection
- Any other malignancy not in remission or treated within 1 year
- History of organ or hematological transplantation
- Uncontrolled hypertension despite treatment
- Body mass index of 40 kg/m2 or higher
- Severe allergic reactions or hypersensitivity to recombinant proteins
- Prior treatments including azacitidine, decitabine, lenalidomide, luspatercept (varies by part), or sotatercept
- Recent use of erythropoiesis-stimulating agents, granulocyte colony-stimulating factors, or iron chelation therapy
- Abnormal laboratory values including platelet count, transferrin saturation, ferritin, folate, vitamin B12, or kidney function
- Pregnant or lactating females
- Other conditions considered unsuitable by the investigator
- Investigational site staff or immediate family members involved in the study
- Additional specific exclusion criteria for Part 2 cohorts related to cardiac conditions, bleeding events, and prior treatments
AI-Screening
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Trial Site Locations
Total: 47 locations
1
City of Hope National Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
University of Miami School of Medicine Sylvester Comprehensive Cancer Center (SCCC)
Miami, Florida, United States, 33136
Actively Recruiting
3
H. Lee Moffitt Cancer Center and Research Center
Tampa, Florida, United States, 33612
Actively Recruiting
4
Karmanos Cancer Institute at Mclaren Greater Lansing
Lansing, Michigan, United States, 48910
Completed
5
University of Pittsburgh Medical Health Center
Pittsburgh, Pennsylvania, United States, 15213
Completed
6
Border Medical Oncology Research
Albury, New South Wales, Australia, 2640
Actively Recruiting
7
Tweed Hospital
Tweed Heads, New South Wales, Australia, 2485
Actively Recruiting
8
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Actively Recruiting
9
Townsville University Hospital
Douglas, Queensland, Australia, 4814
Completed
10
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Actively Recruiting
11
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
Actively Recruiting
12
Boxhill Hospital
Box Hill, Victoria, Australia, 3128
Actively Recruiting
13
University Hospital Geelong
Geelong, Victoria, Australia, 3220
Actively Recruiting
14
Austin Health
Heidelberg, Victoria, Australia, 3084
Actively Recruiting
15
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
Actively Recruiting
16
St Vincent's Hospital Melbourne
Melbourne, Victoria, Australia, 3065
Actively Recruiting
17
Ballarat Oncology & Haematology Service
Wendouree, Victoria, Australia, 3355
Completed
18
Fakultni nemocnice Brno
Brno, Czechia
Completed
19
Fakultni nemocnice Kralovske Vinohrady
Prague, Czechia
Actively Recruiting
20
Vseobecna Fakultni Nemocnice Praha
Prague, Czechia
Completed
21
CHU Angers - Hopital Hotel Dieu
Angers, France
Completed
22
Centre Hospitalier de la Region dAnnecy
Épagny, France
Completed
23
CHU de Nantes - Hotel Dieu
Nantes, France
Actively Recruiting
24
CHU Nice - Hopital de l'Archet 1
Nice, France
Actively Recruiting
25
Hopital Saint-Louis
Paris, France
Actively Recruiting
26
CH Rene-Dubos
Pontoise, France
Actively Recruiting
27
CHU de Bordeaux - Hopital Haut-Leveque
Talence, France
Actively Recruiting
28
Klinikum Bayreuth GmbH
Bayreuth, Germany
Actively Recruiting
29
Charite-Campus Benjamin Franklin
Berlin, Germany
Not Yet Recruiting
30
Praxis am Volkspark Berlin
Berlin, Germany
Not Yet Recruiting
31
University Hospital Bonn
Bonn, Germany
Not Yet Recruiting
32
Marien Hospital Dusseldorf GMBH
Düsseldorf, Germany
Actively Recruiting
33
Universitaetsklinikum Duesseldorf AoeR
Düsseldorf, Germany
Completed
34
Klinikum Esslingen GmbH
Esslingen am Neckar, Germany
Actively Recruiting
35
University Hospital Halle (Saale)
Halle, Germany
Not Yet Recruiting
36
Universitaetsklinikum Leipzig AoeR
Leipzig, Germany
Completed
37
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz, Germany
Actively Recruiting
38
Universitaetsmedizin Rostock
Rostock, Germany
Completed
39
Sheba Medical Center - Sheba Fund for Health Services and Research
Ramat Gan, Israel, 52621
Actively Recruiting
40
Sourasky Medical Center - Infrastructure and Health Services Fund of the Tel Aviv Medical Center
Tel Aviv, Israel, 6423906
Completed
41
Middlemore Hospital
Auckland, New Zealand, 2025
Completed
42
Hospital Universitario Central de Asturias
Barcelona, Spain
Actively Recruiting
43
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Actively Recruiting
44
ICO l'Hospitalet - Hospital Duran i Reynals
Barcelona, Spain
Actively Recruiting
45
Hospital Universitario de Salamanca
Salamanca, Spain
Actively Recruiting
46
Hospital Universitario Virgen del Rocio
Seville, Spain
Completed
47
Hospital Universitari i Politecnic La Fe
Valencia, Spain
Actively Recruiting
Research Team
T
Takeda Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
13
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