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Clinical Trials in Spain / NCT02213926
Active, not recruiting Phase 2

An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymphoma

NCT02213926 · tracked via the Priya Life Science Spain tracker
Phase
Phase 2
Started
2015-03-02
Last updated
2026-08-04

Condition(s) studied

Mantle Cell Lymphoma (MCL)

Investigational drug(s) / intervention(s)

ACP-196 (acalabrutinib) →

Study summary

The purpose of this study is to characterize the safety and efficacy profile of ACP-196 (acalabrutinib) in subjects with relapsed or refractory Mantle Cell Lymphoma (MCL).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion criteria: * Men and women ≥ 18 years of age. * Pathologically confirmed MCL, with documentation of monoclonal B cells that have a chromosome translocation t(11;14)(q13;q32) and/or overexpress cyclin D1. * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2. * Agreement to use contraception during the study and for 30 days after the last dose of study drugs if sexually active and able to bear or beget children. Exclusion criteria: * A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ACP-196 (acalabrutinib), or put the study outcomes at undue risk * Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, 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. * Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction. * Breast feeding or pregnant

Primary outcome measure(s)

Trial sites (58)

FacilityCityRegionStatus
Research Site Tampa Florida
Research Site Chicago Illinois
Research Site Niles Illinois
Research Site Peoria Illinois
Research Site Boston Massachusetts
Research Site Hackensack New Jersey
Research Site New York New York
Research Site Houston Texas
Research Site Seattle Washington
Research Site Monash Australia
Research Site Sydney Australia
Research Site Wodonga Australia
Research Site Bruges Belgium
Research Site Brussels Belgium
Research Site Brussels Belgium
Research Site Liège Belgium
Research Site Yvoir Belgium
Research Site Prague Czechia
Research Site Angers France
Research Site Caen France
Research Site Clermond Ferrand France
Research Site Créteil France
Research Site Dijon France
Research Site Grenoble France
Research Site La Roche - Sure-Yon France
Research Site Lille France
Research Site Montpellier France
Research Site Nantes France
Research Site Paris France
Research Site Paris France
Research Site Pessac France
Research Site Pierre-Bénite France
Research Site Rennes France
Research Site Rouen France
Research Site Saint-Priest-en-Jarez France
Research Site Strasbourg France
Research Site Toulouse France
Research Site Tours France
Research Site Vandœuvre-lès-Nancy France
Research Site Bologna Italy

+ 18 more sites — see the full list on the official registry below.

More Acerta Pharma BV trials in Spain

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02213926 on ClinicalTrials.gov ↗ ← All trials in Spain