The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymphoma
Official Title: An Open-label, Phase 2 Study of ACP-196 in Subjects With Mantle Cell Lymphoma
Study ID: NCT02213926
Brief 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).
Detailed Description: This clinical trial is a Phase 2, multicenter, (approximately 70 global centers), open-label study in subjects with histologically documented MCL, who have relapsed after, or were refractory to, ≥ 1 (but not \> 5) prior treatment regimens. Subjects will be enrolled and will take 100 mg of acalabrutinib twice per day (BID) in repeated 28-day cycles. Treatment with acalabrutinib may be continued until disease progression or an unacceptable drug-related toxicity occurs. Dose modification provisions are provided in the study protocol. All subjects will have hematology, chemistry, and urinalysis safety panels done at screening. Once dosing commences (Day 1), all subjects will be evaluated for safety, including serum chemistry and hematology, once weekly for the first 4 weeks, every 2 weeks in Cycle 2, every 4 weeks in Cycles 3 to 12, and every 24 weeks thereafter. PK/PD testing will be done in Cycles 1 and 2. Tumor assessments will be completed at 8- to 24-week intervals during the trial.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Research Site, Tampa, Florida, United States
Research Site, Chicago, Illinois, United States
Research Site, Niles, Illinois, United States
Research Site, Peoria, Illinois, United States
Research Site, Boston, Massachusetts, United States
Research Site, Hackensack, New Jersey, United States
Research Site, New York, New York, United States
Research Site, Houston, Texas, United States
Research Site, Seattle, Washington, United States
Research Site, Monash, , Australia
Research Site, Sydney, , Australia
Research Site, Wodonga, , Australia
Research Site, Brugge, , Belgium
Research Site, Bruxelles, , Belgium
Research Site, Bruxelles, , 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, Creteil, , France
Research Site, Dijon, , France
Research Site, Grenoble Cedex 09, , France
Research Site, La Roche - Sure-Yon, , France
Research Site, Lille, , France
Research Site, Montpellier, , France
Research Site, Nantes, , France
Research Site, Paris cedex 13, , France
Research Site, Paris, , France
Research Site, Pessac, , France
Research Site, Pierre-Benite, , France
Research Site, Rennes, , France
Research Site, Rouen, , France
Research Site, St Priest en Jarez, , France
Research Site, Strasbourg Cedex, , France
Research Site, Toulouse, , France
Research Site, Tours, , France
Research Site, Vandoeuvre-les-Nancy, , France
Research Site, Bologna, , Italy
Research Site, Meldola, , Italy
Research Site, Milano, , Italy
Research Site, Novara, , Italy
Research Site, Amsterdam, , Netherlands
Research Site, Maastricht, , Netherlands
Research Site, Rotterdam, , Netherlands
Research Site, Kraków, , Poland
Research Site, Lodz, , Poland
Research Site, Olsztyn, , Poland
Research Site, Badalona, , Spain
Research Site, Pamplona, , Spain
Research Site, Cardiff, , United Kingdom
Research Site, Leeds, , United Kingdom
Research Site, Leicester, , United Kingdom
Research Site, Nottingham, , United Kingdom
Research Site, Oxford, , United Kingdom
Research Site, Plymouth, , United Kingdom
Research Site, Southampton, , United Kingdom
Name: Acerta Pharma
Affiliation: 1-888-292-9613
Role: STUDY_DIRECTOR