Page 63 - MEMORIA_SEHH-FEHH_2023

MEMORIA ANUAL 2023
SOCIEDAD ESPAÑOLA DE
HEMATOLOGÍA Y HEMOTERAPIA
GESMD
FUNDACIÓN ESPAÑOLA DE
HEMATOLOGÍA Y HEMOTERAPIA
• A Phase 1, Open-label, Dose-finding Study of CC-91633 (BMS-986397) in Subjects With
Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-Risk
Myelodysplastic Syndromes. Fase I. Hospital Clínic de Barcelona, Hospital Universitario
12 de Octubre, Hospital Universitari Vall d’Hebron, Hospital Universitario Virgen del Rocío.
• A Randomized, Double-blind, Placebo-controlled Phase 3 Study of SY-1425 Plus
Azacitidine Versus Placebo Plus Azacitidine in Newly Diagnosed, RARA-positive Adult
Patients With Higher-risk Myelodysplastic Syndrome. Fase III. Clínica Universidad de
Navarra (Madrid), ICO Badalona-Hospital Germans Trias i Pujol, Hospital Universitario Fun-
dación Jiménez Díaz, Hospital Universitari Vall d’Hebron, Hospital Clínico Universitario de
Valencia, Hospital Universitario de Salamanca, Hospital Universitario Central de Asturias.
• A Phase 2a/2b, Open-label, Proof of Concept (Phase 2a) and Double-blind, Ran-
domized, Placebo-Controlled (Phase 2b), Multicenter, Efficacy, and Safety Study of
AG-946 in Participants With Anemia Due to Lower-Risk Myelodysplastic Syndromes.
Fase II. Hospital Universitario de Salamanca, Hospital Reina Sofía, Hospital Universitario
La Paz, Hospital Universitario HM Sanchinarro, Complejo Asistencial Universitario de Sa-
lamanca, Hospital Universitario Virgen del Rocío.
• An Open-label, Multicenter Phase 1 Trial to Evaluate the Safety, Pharmacokinetics
and Pharmacodynamics of Splicing Modulator H3B-8800 for Subjects With Myelo-
dysplastic Syndromes, Acute Myeloid Leukemia, and Chronic Myelomonocytic Leuke-
mia. Fase I. Hospital Universitario de Salamanca, Hospital Universitari i Politècnic La Fe,
Hospital Universitario Fundación Jiménez Díaz.
Completados
• FGCL-4592-082: A Phase 3 Randomized Double-Blind Placebo-Controlled Study In-
vestigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia
in Patients With Lower Risk Myelodysplastic Syndrome (MDS) With Low Red Blood Cell
(RBC) Transfusion Burden (LTB). Fase III. Hospital Universitario Ramón y Cajal, Hospital
Universitari i Politècnic La Fe, ICO L’Hospitalet-Hospital Duran i Reynals, Hospital Univer-
sitari Vall d’Hebron, Hospital General Universitario Gregorio Marañón, Hospital del Mar
de Barcelona, Complejo Asistencial Universitario de Salamanca.
• A Study to Evaluate Imetelstat (GRN163L) in Transfusion-Dependent Subjects With
IPSS Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) That is Relapsed/
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