A Global Multicenter, Double-Blind, Randomized, Registrational Phase 3 Study of Lisaftoclax(APG-2575) in Combination with Azacitidine (AZA) in Patients with Newly Diagnosed Higher Risk Myelodysplastic Syndrome (HR-MDS) (GLORA-4)
ESTADO CLÍNICO
Reclutando
FASE/S DEL ENSAYO
Fase III
PATOLOGÍA
Leucemia linfática crónica y otros SLPC, Síndromes mielodisplásicos, Linfoma
CENTRO INVESTIGADOR
H.G.U. Gregorio Marañón
INVESTIGADOR PRINCIPAL
Ramón García-Sanz
CENTRO INVESTIGADOR
MD Anderson Cancer Center Madrid
INVESTIGADOR PRINCIPAL
Adolfo De la Fuente Burguera
CENTRO INVESTIGADOR
H.U. Ramón y Cajal
INVESTIGADOR PRINCIPAL
Kyra Velazquez Kennedy
CENTRO INVESTIGADOR
H.U. La Paz
INVESTIGADOR PRINCIPAL
Raquel De Paz Arias
FECHA DE APERTURA
Abril, 2025
FECHA DE CIERRE
,
CRITERIOS DE INCLUSIÓN
Aged 18 years old.
Newly Diagnosed MDS is defined according to 2022 World Health Organization classification (5th Edition)
Eastern Cooperative Oncology Group (ECOG) performance status 2.
Life expectancy 3 months.
Able to receive oral medication.
Adequate organ functions as defined below: - Creatinine clearance 30 ml/min (calculated with Cockcroft formula, as shown in Annex 3) - Total bilirubin < 1.5 × ULN (except Gilbert's syndrome, hyperbilirubinemia due to regular blood transfusions as assessed by the investigator) - Aspartate aminotransferase (ALT) and alanine aminotransferase (AST) 2.5 × ULN
Negative urine or serum pregnancy test prior to dosing in women of childbearing potential. Women of childbearing potential (postmenopausal women must have been postmenopausal for at least 12 months to be considered of non-childbearing potential) and their partners are willing to use contraception as deemed effective by the investigator during treatment and for at least 6 months after the last dose of study drug.
Subjects must have the ability to understand and voluntarily sign a written informed consent form that must be signed prior to performing any trial-specific study procedures.
Subjects must be willing to participate in the study and are able to complete study procedures and follow-up examinations.
Newly Diagnosed MDS is defined according to 2022 World Health Organization classification (5th Edition)
Eastern Cooperative Oncology Group (ECOG) performance status 2.
Life expectancy 3 months.
Able to receive oral medication.
Adequate organ functions as defined below: - Creatinine clearance 30 ml/min (calculated with Cockcroft formula, as shown in Annex 3) - Total bilirubin < 1.5 × ULN (except Gilbert's syndrome, hyperbilirubinemia due to regular blood transfusions as assessed by the investigator) - Aspartate aminotransferase (ALT) and alanine aminotransferase (AST) 2.5 × ULN
Negative urine or serum pregnancy test prior to dosing in women of childbearing potential. Women of childbearing potential (postmenopausal women must have been postmenopausal for at least 12 months to be considered of non-childbearing potential) and their partners are willing to use contraception as deemed effective by the investigator during treatment and for at least 6 months after the last dose of study drug.
Subjects must have the ability to understand and voluntarily sign a written informed consent form that must be signed prior to performing any trial-specific study procedures.
Subjects must be willing to participate in the study and are able to complete study procedures and follow-up examinations.
CRITERIOS DE EXCLUSIÓN
Previous diagnosis of xxx
Any of the following cardiac abnormalities (as determined by the study physician based on clinical examination assessments): - Any history of myocardial infarction within 6 months - Congestive heart failure (CHF) (New York Heart Association [NYHA] Class III or IV) or left ventricular ejection fraction (LVEF) < 40% - Symptomatic ventricular arrhythmia uncontrolled by medication - Any history of familial long QT syndrome - The mean QT interval calculated from 3 electrocardiogram (ECG) readings (1 to 3 minutes apart) is > 470 (Using Fridercia's correction: QTcF = QT/RR0.33)
Second malignancies or previous malignancies with a disease-free interval of less than 1 year at the time of signing the informed consent (except for subjects with adequately resected cutaneous basal cell or squamous cell carcinoma or resected carcinoma in situ).
Have history of HSCT.
Other clinically significant uncontrolled symptoms, including but not limited to: uncontrolled active systemic infection (virus, bacteria or fungi), known clinically active hepatitis B or C, or HIV infection. (as determined by the study physician based on clinical examination assessments).
Have malabsorption syndrome or other conditions and are not suitable for enteral drug administration.
Have any other conditions or illnesses which, in the investigator's judgment, makes them unsuitable for participation in this study, , including but not limited to; Women who are breast feeding or planning to donate eggs within 6 months after the end of the study treatment History of hypersensitivity to compounds related to lisaftoclax or AZA or to any of their excipients History of bleeding disorders or active uncontrolled coagulopathy.
Any of the following cardiac abnormalities (as determined by the study physician based on clinical examination assessments): - Any history of myocardial infarction within 6 months - Congestive heart failure (CHF) (New York Heart Association [NYHA] Class III or IV) or left ventricular ejection fraction (LVEF) < 40% - Symptomatic ventricular arrhythmia uncontrolled by medication - Any history of familial long QT syndrome - The mean QT interval calculated from 3 electrocardiogram (ECG) readings (1 to 3 minutes apart) is > 470 (Using Fridercia's correction: QTcF = QT/RR0.33)
Second malignancies or previous malignancies with a disease-free interval of less than 1 year at the time of signing the informed consent (except for subjects with adequately resected cutaneous basal cell or squamous cell carcinoma or resected carcinoma in situ).
Have history of HSCT.
Other clinically significant uncontrolled symptoms, including but not limited to: uncontrolled active systemic infection (virus, bacteria or fungi), known clinically active hepatitis B or C, or HIV infection. (as determined by the study physician based on clinical examination assessments).
Have malabsorption syndrome or other conditions and are not suitable for enteral drug administration.
Have any other conditions or illnesses which, in the investigator's judgment, makes them unsuitable for participation in this study, , including but not limited to; Women who are breast feeding or planning to donate eggs within 6 months after the end of the study treatment History of hypersensitivity to compounds related to lisaftoclax or AZA or to any of their excipients History of bleeding disorders or active uncontrolled coagulopathy.
DESCRIPCIÓN
To evaluate the efficacy of xxx
PALABRAS CLAVE
leucemia linfocítica crónica (llc / cll), mds, myelodysplastic syndrome
