Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04419649 · ClinicalTrials.gov registry record · Phase 2
A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS)
A Phase 2 study of Myelodysplastic Syndromes and Cytopenia, sponsored by Takeda.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 160
- Enrollment target
- 20
- Study locations
NCT04419649: Recruiting Phase 2 study of Myelodysplastic Syndromes and Cytopenia, sponsored by Takeda.
NCT04419649 is a Phase 2 study of Myelodysplastic Syndromes and Cytopenia that is actively recruiting participants, run by Takeda. The registered enrollment target is 160 participants, below the 284-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (44% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04419649, a Phase 2 study of Myelodysplastic Syndromes and Cytopenia, is actively recruiting participants, sponsored by Takeda.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 160 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
An AE is defined as any untoward medical occurrence, in a clinical study participant administered a medicinal product, that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not it is related to the medicinal (investigational) product. An SAE is any untoward medical occ
Conditions Studied
Interventions
- DRUG Elritercept
Study Locations (20)
Victoria
- Boxhill Hospital - Box Hill
- University Hospital Geelong - Geelong
- Austin Health - Heidelberg
- Royal Melbourne Hospital - Melbourne
- St Vincent's Hospital Melbourne - Melbourne
- Ballarat Oncology & Haematology Service - Wendouree
New South Wales
- Border Medical Oncology Research - Albury
- Tweed Hospital - Tweed Heads
- Westmead Hospital - Westmead
Other
- Fakultni nemocnice Brno - Brno
- Fakultni nemocnice Kralovske Vinohrady - Prague
- Vseobecna Fakultni Nemocnice Praha - Prague
Florida
- University of Miami School of Medicine Sylvester Comprehensive Cancer Center (SCCC) - Miami
- H. Lee Moffitt Cancer Center and Research Center - Tampa
South Australia
- Royal Adelaide Hospital - Adelaide
- Flinders Medical Centre - Bedford Park
California
- City of Hope National Medical Center - Duarte
Michigan
- Karmanos Cancer Institute at Mclaren Greater Lansing - Lansing
Pennsylvania
- University of Pittsburgh Medical Health Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2020-08-19 |
| Est. Completion | 2031-10-30 |
| Phase | Phase 2 |
What NCT04419649 shows while recruiting
NCT04419649 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 284-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (44% lower).
The record links to 2 conditions, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 1 intervention - of which Elritercept is the first listed.
NCT04419649 names 20 study sites across 9 states, led by Victoria, New South Wales, Other.
Frequently Asked Questions
What is clinical trial NCT04419649 about?
NCT04419649 is a clinical study titled "A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS)". 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 s...
What is the current status of trial NCT04419649?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 2020-08-19. Estimated completion is 2031-10-30.
What conditions does trial NCT04419649 study?
This clinical trial studies the following conditions: Myelodysplastic Syndromes, Cytopenia.
What interventions are being tested in trial NCT04419649?
The interventions under investigation include: Elritercept (DRUG).
Who is sponsoring clinical trial NCT04419649?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04419649 being conducted?
This trial has 20 study locations across California, Florida, Michigan, Pennsylvania, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Myelodysplastic Syndromes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04419649's enrollment target sits among peer trials
160 39th of 173 higher than 134 of 173 other Myelodysplastic Syndromes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndromes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Pilot, Open-Label Study of Luspatercept for Patients With Lower Risk Myelodysplastic Syndromes (MDS)
RECRUITING · Phase 2
-
Eltrombopag as a Novel Therapeutic Approach for Low-risk MDS and CMML With TET2 Mutations
RECRUITING · Phase 2
-
Luspatercept for Anemia in Lower Risk MDS or Non-proliferative MDS/MPN Neoplasms
RECRUITING · Phase 2
-
A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study)
RECRUITING · Phase 2
-
Ascorbate in Myelodysplastic Syndrome
RECRUITING · Phase 2
-
A Study of Momelotinib in Participants With Low-risk Myelodysplastic Syndrome
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00501826 · 160 participants · Phase 2
Combination Chemotherapy and Nelarabine in Treating Patients With T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
- NCT00932139 · 160 participants · NA
Effect of Electro-Acupuncture on Blood Pressure
- NCT00992901 · 160 participants · Early Phase 1
Role of Neural and Hormonal Regulation Factors on Insulin Secretion After Gastric Bypass Surgery
- NCT01515527 · 160 participants · Phase 2
Cladribine Plus Low Dose Cytarabine (LDAC) Alternating With Decitabine in Patients With Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI