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

Mantle Cell Lymphoma (MCL) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02213926
• Other study ID #: ACE-LY-004
• Secondary ID: 2014-002117-28
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 2, 2015
• Est. completion date: September 1, 2026

Study information

• Verified date: January 2024
• Source: Acerta Pharma BV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 124
• Est. completion date: September 1, 2026
• Est. primary completion date: December 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma (MCL)

Intervention

Drug:
• ACP-196 (acalabrutinib)

Locations

Country	Name	City	State
Australia	Research Site	Monash
Australia	Research Site	Sydney
Australia	Research Site	Wodonga
Belgium	Research Site	Brugge
Belgium	Research Site	Bruxelles
Belgium	Research Site	Bruxelles
Belgium	Research Site	Liège
Belgium	Research Site	Yvoir
Czechia	Research Site	Prague
France	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
France	Research Site	Paris cedex 13
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
Italy	Research Site	Bologna
Italy	Research Site	Meldola
Italy	Research Site	Milano
Italy	Research Site	Novara
Netherlands	Research Site	Amsterdam
Netherlands	Research Site	Maastricht
Netherlands	Research Site	Rotterdam
Poland	Research Site	Kraków
Poland	Research Site	Lodz
Poland	Research Site	Olsztyn
Spain	Research Site	Badalona
Spain	Research Site	Pamplona
United Kingdom	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 States	Research Site	Boston	Massachusetts
United States	Research Site	Chicago	Illinois
United States	Research Site	Hackensack	New Jersey
United States	Research Site	Houston	Texas
United States	Research Site	New York	New York
United States	Research Site	Niles	Illinois
United States	Research Site	Peoria	Illinois
United States	Research Site	Seattle	Washington
United States	Research Site	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Acerta Pharma BV

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Czechia,  France,  Italy,  Netherlands,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR) of ACP-196 (Acalabrutinib) in Subjects With Previously Treated MCL.	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.	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

External Links

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•   redacted CSR Synopsis
•   redacted SAP