Trial Title:
An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymphoma
NCT ID:
NCT02213926
Condition:
Mantle Cell Lymphoma (MCL)
Conditions: Official terms:
Lymphoma
Lymphoma, Mantle-Cell
Acalabrutinib
Conditions: Keywords:
Bruton tyrosine kinase inhibitor
Btk
Mantle Cell Lymphoma
MCL
ACP-196
Acalabrutinib
ACE-LY-004
Calquence
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ACP-196 (acalabrutinib)
Arm group label:
ACP-196 (acalabrutinib) Regimen 1
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
130 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Tampa
Zip:
33612
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Chicago
Zip:
60612
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Niles
Zip:
60714
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Peoria
Zip:
61615
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Boston
Zip:
2215
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Facility:
Name:
Research Site
Address:
City:
New York
Zip:
10021
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Houston
Zip:
77030
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Seattle
Zip:
98109
Country:
United States
Facility:
Name:
Research Site
Address:
City:
Monash
Country:
Australia
Facility:
Name:
Research Site
Address:
City:
Sydney
Zip:
2139
Country:
Australia
Facility:
Name:
Research Site
Address:
City:
Wodonga
Zip:
3690
Country:
Australia
Facility:
Name:
Research Site
Address:
City:
Brugge
Zip:
8000
Country:
Belgium
Facility:
Name:
Research Site
Address:
City:
Bruxelles
Zip:
1000
Country:
Belgium
Facility:
Name:
Research Site
Address:
City:
Bruxelles
Zip:
1200
Country:
Belgium
Facility:
Name:
Research Site
Address:
City:
Liège
Zip:
4000
Country:
Belgium
Facility:
Name:
Research Site
Address:
City:
Yvoir
Zip:
5530
Country:
Belgium
Facility:
Name:
Research Site
Address:
City:
Prague
Zip:
100 34, CZ
Country:
Czechia
Facility:
Name:
Research Site
Address:
City:
Angers
Zip:
49033
Country:
France
Facility:
Name:
Research Site
Address:
City:
Caen
Zip:
14033
Country:
France
Facility:
Name:
Research Site
Address:
City:
Clermond Ferrand
Zip:
63003
Country:
France
Facility:
Name:
Research Site
Address:
City:
Creteil
Zip:
94010
Country:
France
Facility:
Name:
Research Site
Address:
City:
Dijon
Zip:
21000
Country:
France
Facility:
Name:
Research Site
Address:
City:
Grenoble Cedex 09
Zip:
38043
Country:
France
Facility:
Name:
Research Site
Address:
City:
La Roche - Sure-Yon
Zip:
85925
Country:
France
Facility:
Name:
Research Site
Address:
City:
Lille
Zip:
59000
Country:
France
Facility:
Name:
Research Site
Address:
City:
Montpellier
Zip:
34295
Country:
France
Facility:
Name:
Research Site
Address:
City:
Nantes
Zip:
44093
Country:
France
Facility:
Name:
Research Site
Address:
City:
Paris cedex 13
Zip:
75651
Country:
France
Facility:
Name:
Research Site
Address:
City:
Paris
Zip:
75015
Country:
France
Facility:
Name:
Research Site
Address:
City:
Pessac
Zip:
33604
Country:
France
Facility:
Name:
Research Site
Address:
City:
Pierre-Benite
Zip:
69310
Country:
France
Facility:
Name:
Research Site
Address:
City:
Rennes
Zip:
35033
Country:
France
Facility:
Name:
Research Site
Address:
City:
Rouen
Zip:
76038
Country:
France
Facility:
Name:
Research Site
Address:
City:
St Priest en Jarez
Zip:
42270
Country:
France
Facility:
Name:
Research Site
Address:
City:
Strasbourg Cedex
Zip:
67098
Country:
France
Facility:
Name:
Research Site
Address:
City:
Toulouse
Zip:
31100
Country:
France
Facility:
Name:
Research Site
Address:
City:
Tours
Zip:
37000
Country:
France
Facility:
Name:
Research Site
Address:
City:
Vandoeuvre-les-Nancy
Zip:
54500
Country:
France
Facility:
Name:
Research Site
Address:
City:
Bologna
Zip:
40138
Country:
Italy
Facility:
Name:
Research Site
Address:
City:
Meldola
Zip:
47014
Country:
Italy
Facility:
Name:
Research Site
Address:
City:
Milano
Zip:
20132
Country:
Italy
Facility:
Name:
Research Site
Address:
City:
Novara
Zip:
28100
Country:
Italy
Facility:
Name:
Research Site
Address:
City:
Amsterdam
Zip:
1105 AZ
Country:
Netherlands
Facility:
Name:
Research Site
Address:
City:
Maastricht
Zip:
6202 AZ
Country:
Netherlands
Facility:
Name:
Research Site
Address:
City:
Rotterdam
Zip:
3062 PA
Country:
Netherlands
Facility:
Name:
Research Site
Address:
City:
Kraków
Zip:
30-727
Country:
Poland
Facility:
Name:
Research Site
Address:
City:
Lodz
Zip:
93-510
Country:
Poland
Facility:
Name:
Research Site
Address:
City:
Olsztyn
Zip:
10-228
Country:
Poland
Facility:
Name:
Research Site
Address:
City:
Badalona
Zip:
8916
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Facility:
Name:
Research Site
Address:
City:
Cardiff
Zip:
CF14 4XW
Country:
United Kingdom
Facility:
Name:
Research Site
Address:
City:
Leeds
Zip:
LS9 7TF
Country:
United Kingdom
Facility:
Name:
Research Site
Address:
City:
Leicester
Zip:
LE1 7RH
Country:
United Kingdom
Facility:
Name:
Research Site
Address:
City:
Nottingham
Zip:
NG5 1PB
Country:
United Kingdom
Facility:
Name:
Research Site
Address:
City:
Oxford
Zip:
0X3 7LE
Country:
United Kingdom
Facility:
Name:
Research Site
Address:
City:
Plymouth
Zip:
PL6 8DH
Country:
United Kingdom
Facility:
Name:
Research Site
Address:
City:
Southampton
Zip:
SO16 6YD
Country:
United Kingdom
Start date:
March 2, 2015
Completion date:
September 6, 2026
Lead sponsor:
Agency:
Acerta Pharma BV
Agency class:
Industry
Source:
Acerta Pharma BV
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02213926
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