Informations générales (source: ClinicalTrials.gov)
A Phase 2, Open-Label, Ascending Dose Study of KER-050 for the Treatment of Anemia in Patients With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS)
Interventional
Phase 2
Keros Therapeutics, Inc. (Voir sur ClinicalTrials)
août 2020
novembre 2025
26 juin 2024
The purpose of this study is to evaluate the effects of KER-050 on anemia in patients
with very low, low or intermediate risk MDS.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL NOVO | BENRAMDANE | 04/07/2024 11:05:00 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier de la Région d'Annecy - Épagny - France | Natacha Mauz | Contact (sur clinicalTrials) | |||
| CHU Angers - Hôpital Hôtel Dieu - Angers - France | Sylvain Thepot | Contact (sur clinicalTrials) | |||
| CHU de Bordeaux - Hôpital Haut-Lévêque - Talence - France | Sophie Dimicoli Salazar | Contact (sur clinicalTrials) | |||
| CHU de Nantes - Hotel Dieu - Nantes - France | Alice Garnier | Contact (sur clinicalTrials) | |||
| CHU Nice - Hôpital de l'Archet - Nice - France | Thomas Cluzeau | Contact (sur clinicalTrials) | |||
| Hôpital Saint-Louis - Paris - France | Lionel Ades | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
1. Diagnosis of MDS according to World Health Organization (WHO)/French American
British (FAB) classification that meets Revised International Prognostic Scoring
System (IPSS-R) classification of very low, low, or intermediate risk disease.
2. < 5% blasts in bone marrow.
3. Peripheral blood white blood cell count <13,000/µL.
4. Anemia defined as:
1. In non-transfused participants, having received no red blood cell (RBC)
transfusions within 8 weeks Hgb concentration ≤ 10.0 g/dL OR
2. In LTB participants, having received 1 to 3 units RBCs for Hgb ≤ 9.0 g/dL
within 8 weeks OR
3. In HTB participants, having received ≥ 4 units of RBCs for Hgb ≤ 9.0 g/dL
within 8 weeks
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (if
related to anemia.
6. Females of child-bearing potential and sexually active males must agree to use
effective methods of contraception.
Key
1. Diagnosis of MDS according to World Health Organization (WHO)/French American
British (FAB) classification that meets Revised International Prognostic Scoring
System (IPSS-R) classification of very low, low, or intermediate risk disease.
2. < 5% blasts in bone marrow.
3. Peripheral blood white blood cell count <13,000/µL.
4. Anemia defined as:
1. In non-transfused participants, having received no red blood cell (RBC)
transfusions within 8 weeks Hgb concentration ≤ 10.0 g/dL OR
2. In LTB participants, having received 1 to 3 units RBCs for Hgb ≤ 9.0 g/dL
within 8 weeks OR
3. In HTB participants, having received ≥ 4 units of RBCs for Hgb ≤ 9.0 g/dL
within 8 weeks
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (if
related to anemia.
6. Females of child-bearing potential and sexually active males must agree to use
effective methods of contraception.
Key
1. Any active infection requiring parenteral antibiotic therapy within 28 days prior to
Cycle 1 Day 1 or oral antibiotics within 14 days of Cycle 1 Day 1.
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. Vitamin B12 deficiency.
4. Prior treatment with azacitidine, decitabine, lenalidomide, luspatercept, or
sotatercept.
5. Treatment within 28 days prior to Cycle 1 Day 1 with:
1. Erythropoiesis stimulating agent (ESA) OR
2. Granulocyte colony-stimulating factor (G-CSF) OR
3. Granulocyte-macrophage colony-stimulating factor (GM-CSF)
6. Iron chelation therapy if initiated within 8 weeks prior to Cycle 1 Day 1.
7. Vitamin B12 therapy within 8 weeks prior to Cycle 1 Day 1.
8. Treatment with another investigational drug or device or approved therapy for
investigational use < or = 28 days prior to Cycle 1 Day 1, or if the half-life of
the previous product is known, within 5 times the half-life prior to Cycle 1 Day 1,
whichever is longer.
9. Platelet count > 450 x 10*9/L or < 30 x 10*9/L.
10. Transferrin saturation < 15%.
11. Ferritin < 50 µg/L.
12. Folate < 4.5 nmol/L (< 2.0 ng/mL).
13. Vitamin B12 < 148 pmol/L (< 200 pg/mL).
14. Estimated glomerular filtration rate (GFR) < 40 mL/min/1.73 m2 (as determined by the
Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI].
15. Pregnant or lactating females