Estudio de Fase III Aleatorizado, Doble Ciego, Controlado, de Grupos Paralelos de Volasertib Intravenoso en Combinación con Citarabina Subcutánea a Dosis Bajas vs. Placebo + Citarabina a Dosis Bajas en Pacientes ≥65 Años con Leucemia Mieloide Aguda sin Tratamiento Previo, No Elegibles para Terapia Intensiva de Inducción a la Remisión

CompletadoFase 3ClinicalTrials.gov

ID: NCT01721876Tipo: INTERVENTIONALInicio: 29 de ene de 2013Fin estimado: 28 de may de 2021

Resumen

Investigar la eficacia, seguridad y farmacocinética de volasertib intravenoso + citarabina subcutánea a dosis bajas en pacientes ≥65 años con leucemia mieloide aguda sin tratamiento previo, no elegibles para terapia intensiva de inducción a la remisión.

Elegibilidad

Edad mínima: 65 YearsSexo: ALL

Criterios de inclusión

Age \>= 65years.
Cytologically/histologically confirmed acute myeloid leukaemia (AML) according to WHO classification; (except for acute promyelocytic leukaemia (APL).
Previously untreated AML (except for hydroxyurea and/or corticosteroid therapy for no more than 28 days (cumulative)). Previous therapy for Myelodysplastic Syndrome (MDS) is allowed.
Investigator considers patient ineligible for intensive remission induction therapy based on documented medical reasons (e.g. disease characteristics like AML genetics, type of AML (de novo or secondary), and patient characteristics like performance score, concomitant diagnoses, organ dysfunctions).
Patient is eligible for Low-Dose Cytarabine (LDAC) treatment.
Eastern co-operative oncology group (ECOG) performance score \<= 2 at screening.
Signed and dated written informed consent by start date of Screening visit in accordance with Good Clinical Practice (GCP) and local legislation.

Criterios de exclusión

Prior or concomitant chemotherapy for AML (with the exception of hydroxyurea and/or corticosteroid therapy for no more than 28 days (cumulative)). Please note that any prior therapy for MDS is allowed.
Treatment with any investigational drug within 2 weeks before first administration of present trial drug.
Acute promyelocytic leukaemia (French-American-British (FAB) classification subtype M3).
Current clinical central nervous system (CNS) symptoms deemed by the investigator to be related to leukaemic CNS involvement (no lumbar puncture required, clinical assessment per investigator´s judgement is sufficient).
Hypersensitivity to one of the trial drugs or the excipients.
Severe illness or organ dysfunction involving the heart, kidney, liver or other organ system (e.g. active infection, clinically relevant impairment of cardiac function, severe heart failure/cardiac insufficiency, unstable angina pectoris or history of recent myocardial infarction), which in the opinion of the investigator precludes treatment with LDAC.
Corrected QT interval according to Fridericia (QTcF) prolongation \> 470 ms or QT prolongation deemed clinically relevant by the investigator (e.g., congenital long QT syndrome).The QTcF will be calculated as the mean of the 3 Electrocardiogram (ECGs) taken at screening.
Total bilirubin \> 3 x upper limit of normal (ULN).
Creatinine clearance (CLcr) \< 30 ml/min (estimated creatinine clearance by the Cockcroft-Gault (C-G) equation) .
Active hepatitis B or hepatitis C, or laboratory evidence for a chronic infection.
HIV infection.
Second malignancy currently requiring active therapy (except for hormonal/anti-hormonal treatment e.g. in prostate or breast cancer).
Any significant concurrent psychiatric disorder or social situation that according to the investigator´s judgement would compromise patient´s safety or compliance, interfere with consent, study participation, or interpretation of study results.
Known or suspected active alcohol or drug abuse.
Patient unable to comply with the protocol, in the opinion of the investigator.
Male patients with partners of childbearing potential who are unwilling to use condoms in combination with a second medically acceptable method of contraception during the trial and for a minimum of 6 months after study treatment.

Intervenciones

drug

Placebo

Placebo matching Volasertib

drug

Volasertib

drug

Cytarabine

Ubicaciones

Fundacion COIR

Mendoza, Argentina

Hospital Central de Salud Zenón Santillan

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalBoehringer Ingelheim

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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