Clinical Trials in Italy / 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 Italy tracker
Condition(s) studied
Mantle Cell Lymphoma (MCL)
Investigational drug(s) / intervention(s)
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
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)
- Overall Response Rate (ORR) of ACP-196 (Acalabrutinib) in Subjects With Previously Treated MCL. — From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months. 1 cycle =28 days
The overall response rate (ORR) is defined as the proportion of subjects achieving either a partial remission (response) (PR) or complete response (CR) according to the Lugano Classification for NHL (Cheson 2014) as assessed by investigators, where SD stands for Stable Disease, PD for Progressive Disease and NE for Not Evaluable.
Trial sites (58)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 Italy
ACP-196 (Acalabrutinib), a Novel Bruton Tyrosine Kinase (BTK) Inhibitor, for Treatment of Chronic Lymphocytic Leukemia, Richter's Syndrome or Prolymphocytic Leukemia
Active, not recruiting
Study of Acalabrutinib Alone or in Combination Therapy in Subjects With B-cell Non-Hodgkin Lymphoma
Active, not recruiting
A Study of Acalabrutinib in Combination With Rituximab + (Bendamustine or Venetoclax) in Subjects With MCL
Active, not recruiting
Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment naïve CLL
Active, not recruiting
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 Italy