Clinical trial · Interventional
Study of Sotatercept for the Treatment of Anemia in low-or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) or Non-proliferative Chronic Myelomonocytic Leukemia (CMML)
An Open-label, Randomized, Phase 2, Parallel, Dose-Ranging, Multicenter Study of Sotatercept for the Treatment of Patients With Anemia and Low or Intermediate-1 Risk Myelodysplastic Syndromes or Non-proliferative Chronic Myelomonocytic Leukemia (CMML)
NCT01736683CI-TRIAL-00061629completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective of this study is to determine a safe, tolerable and effective dose of sotatercept that results in the greatest frequency of improvement of anemia in patients diagnosed with low- or intermediate-1 risk myelodysplastic syndromes (MDS) or non-proliferative chronic myelomonocytic leukemia (CMML).
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
| Chronic Myelomonocytic Leukemia | Chronic Myelomonocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Chronic Myelomonocytic Leukemia (CMML) | Chronic Myelomonocytic Leukemia | ALIAS | 0.90 |
| Low to Intermediate-1 MDS | — | UNRESOLVED | — |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Myelodysplastic Syndromes (MDS) | Myelodysplastic Syndrome | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sotatercept | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Sotatercept 0.1 mg/kg
- description
- Sotatercept 0.1 mg/kg
- interventionNames
- Drug: Sotatercept
- type
- EXPERIMENTAL
- label
- Sotatercept 0.3 mg/kg
- description
- Sotatercept 0.3 mg/kg
- interventionNames
- Drug: Sotatercept
- type
- EXPERIMENTAL
- label
- Sotatercept 0.5 mg/kg
- description
- Sotatercept 0.5 mg/kg
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men and women ≥ 18 years of age * Documented diagnosis of myelodysplastic syndromes (MDS) or non-proliferative chronic myelomonocytic leukemia (CMML), white blood cells (WBC) ≤ 13,000 /mm\^3, World Health Organization (WHO) that meets International Prognostic Scoring System (IPSS) criteria for low or intermediate-1 risk disease * Anemia, Hemoglobin (Hgb) ≤ 9.0 g/dL or ≥ 2 units of Red Blood Cells (RBCs) within 84 days * No response or loss of response to Erythropoiesis-Stimulating Agents (ESAs) or erythropoetin (EPO) \> 500 mU/ml * Eastern Cooperative Group (ECOG) score ≤2. * Creatinine \< 1.5 \* Upper Limit of the Normal (ULN) * Total bilirubin ≤3.0 mg/dL * Aspartate aminotransferase (AST)/Serum glutamic oxaloacetic transaminase (SGOT) \& Alanine Aminotransferase (ALT)/Serum Glutamic Pyruvic (SGPT) ≤3.0 \* Upper Limit of Norma (ULN) * Free of metastatic malignancy (other than MDS) for ≥2 years * Highly effective methods of birth control for females and males Exclusion Criteria: * Chromosome 5q deletion * Pregnant or breast feeding women and males who do not agree to use condom during the sexual contact with females of childbearing potential * Major surgery within 30 days * Incomplete recovery or incomplete healing of wounds from previous surgery * Heart failure ≥3 (New York Heart Association (NYHA)) * Thromboembolic or myocardial infarction event within 6 months * Concurrent anti-cancer cytotoxic chemotherapy * History of severe allergic or anaphylactic reaction or hypersensitivity to recombinant protein * Known positive for Human Immunovirus (HIV) or infectious Hepatitis type C or active infectious Hepatitis type B * Clinically significant anemia unrelated to MDS * Thrombocytopenia (\<30,000/uL) * Uncontrolled hypertension * Treatment with another investigational drug or device within 28 days prior to Day 1 * Prior exposure to sotatercept (ACE-011) * Any serious medical condition, lab abnormality or psychiatric illness
References
Publications (1)
- DERIVEDKomrokji R, Garcia-Manero G, Ades L, Prebet T, Steensma DP, Jurcic JG, Sekeres MA, Berdeja J, Savona MR, Beyne-Rauzy O, Stamatoullas A, DeZern AE, Delaunay J, Borthakur G, Rifkin R, Boyd TE, Laadem A, Vo B, Zhang J, Puccio-Pick M, Attie KM, Fenaux P, List AF. Sotatercept with long-term extension for the treatment of anaemia in patients with lower-risk myelodysplastic syndromes: a phase 2, dose-ranging trial. Lancet Haematol. 2018 Feb;5(2):e63-e72. doi: 10.1016/S2352-3026(18)30002-4. Epub 2018 Jan 10. PMID 29331635