A Randomized, Multicenter, Open-Label, Phase 3 Study to Compare the Efficacy and Safety of Acalabrutinib (ACP-196) in Combination With Venetoclax With and Without Obinutuzumab Compared to Investigator's Choice of Chemoimmunotherapy in Subjects With Previously Untreated Chronic Lymphocytic Leukemia Without Del(17p) or TP53 Mutation (AMPLIFY)

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT03836261Tipo: INTERVENTIONALInicio: 25 de feb de 2019Fin estimado: 31 de ene de 2027

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate the efficacy and safety of acalabrutinib in combination with venetoclax and acalabrutinib in combination with venetoclax with and without obinutuzumab compared to chemoimmunotherapy in subjects with previously untreated CLL

Descripción detallada

This randomized, global, multicenter, open-label, Phase 3 study will evaluate the efficacy and safety of AV and AVG versus chemoimmunotherapy (FCR or BR) in subjects with previously untreated CLL without del(17p) or TP53. Subjects will be randomized in a 1:1:1 ratio into 3 arms through a block stratified randomization procedure. The study includes screening (35 days), treatment (from randomization until study drug discontinuation) and follow-up phase.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 130 YearsSexo: ALL

Criterios de inclusión

Men and women ≥18 years of age.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Diagnosis of CLL that meets published diagnostic criteria (Hallek et al. 2018)
Active disease per IWCLL 2018 criteria that requires treatment.
Participants must use highly effective birth control throughout the study.

Criterios de exclusión

Any prior CLL-specific therapies.
Detected del(17p) or TP53 mutation.
Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL) (e.g., Richter's transformation, prolymphocytic leukemia \[PLL\], or diffuse large B cell lymphoma \[DLBCL\]), or central nervous system (CNS) involvement by leukemia.
History of confirmed progressive multifocal leukoencephalopathy (PML).
Received any investigational drug within 30 days before first dose of study drug.
Major surgical procedure within 30 days before the first dose of study drug.
Significant cardiovascular disease such as symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 or 4 cardiac disease. Note: Subjects with controlled, asymptomatic atrial fibrillation are allowed to enroll on study.
Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach, or extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
Received a live virus vaccination within 28 days of first dose of study drug.
Known history of infection with human immunodeficiency virus (HIV).
Serologic status reflecting active hepatitis B or C infection.
History of known hypersensitivity or anaphylactic reactions to study drugs or excipients.
History of stroke or intracranial hemorrhage within 6 months before first dose of study drug.
Known bleeding disorders.
Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists.
Female participants must not be breastfeeding or pregnant.
Concurrent participation in another therapeutic clinical trial.

Intervenciones

drug

Acalabrutinib

Acalabrutinib,

drug

Venetoclax

drug

Chemoimmunotherapy

fludarabine/cyclophosphamide/rituximab (FCR), bendamustine/rituximab (BR)

drug

Obinutuzumab

Ubicaciones

Research Site

Buenos Aires, Argentina

Research Site

Buenos Aires, Argentina

Research Site

Capital Federal, Argentina

Research Site

Córdoba, Argentina

Patrocinadores

PrincipalAcerta Pharma BV

ColaboradorAstraZeneca

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