A Phase 3, Randomized, Double-blind, Placebo-controlled, ... | EligiMed

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Bendamustine and Rituximab (BR) Alone Versus in Combination With Acalabrutinib (ACP-196) in Subjects With Previously Untreated Mantle Cell Lymphoma

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT02972840RENIS: IS002199Tipo: INTERVENTIONALInicio: 5 de abr de 2017Fin estimado: 15 de feb de 2027

Traducción no disponible, mostrando original

Resumen

This study is evaluating the efficacy of acalabrutinib in combination with bendamustine and rituximab (BR) compared with placebo plus BR in subjects with previously untreated mantle cell lymphoma.

Descripción detallada

To evaluate the efficacy of acalabrutinib in combination with bendamustine and rituximab (BR) compared with placebo plus BR based on Independent Review Committee (IRC) assessment of progression-free survival (PFS) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL) in subjects with previously untreated mantle cell lymphoma (MCL).

Elegibilidad

Edad mínima: 65 YearsSexo: ALL

Criterios de inclusión

Men and women, ≥ 65 years of age.
Pathologically confirmed MCL, with documentation of a chromosome translocation t(11;14)(q13;q32) and/or overexpression of cyclin D1 in association with other relevant markers (eg, CD5, CD19, CD20, PAX5) .
MCL requiring treatment and for which no prior systemic anticancer therapies have been received.
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
Agreement to use highly effective forms of contraception during the study and 6 months after the last dose of bendamustine, or 12 months after the last dose of rituximab, whichever is longest .

Criterios de exclusión

Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of first dose of study drug, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or corrected QT interval (QTc) \> 480 msec (calculated using Friderica's formula: QT/RR0.33) at screening. Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study.
Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
Uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment), or intravenous anti infective treatment within 2 weeks before first dose of study drug.
Concurrent participation in another therapeutic clinical trial.

Intervenciones

drug

Acalabrutinib

Administered orally (PO)

drug

Bendamustine

Administered intravenously (IV)

drug

Rituximab

Administered intravenously (IV)

drug

Placebo

Placebo comparator

Ubicaciones

Research Site

Buenos Aires, Argentina

Research Site

Buenos Aires, Argentina

Research Site

Buenos Aires, Argentina

Research Site

Buenos Aires, Argentina

Research Site

Caba, Argentina

Research Site

Córdoba, Argentina

Patrocinadores

PrincipalAcerta Pharma BV

ColaboradorAstraZeneca

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