⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymphoma

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.

Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Acerta Pharma

Affiliation: 1-888-292-9613

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: