Mantle Cell Lymphoma (MCL)Phase 2NCT02213926
An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymphoma
A Phase 2 study testing ACP-196 (acalabrutinib) in people with Mantle Cell Lymphoma (MCL), run by Acerta Pharma BV at 58 sites in 10 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mantle Cell Lymphoma (MCL)
- What is being tested?
- ACP-196 (acalabrutinib)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 58 sitesin 10 countries
- Study dates
- 2 Mar 2015to 6 Sep 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
58 sites in 10 countries.
58 sites in 10 countries
France21 sites
Research Site
Angers, 49033
Research Site
Caen, 14033
Research Site
Clermond Ferrand, 63003
Research Site
Créteil, 94010
Research Site
Dijon, 21000
Research Site
Grenoble, 38043
Research Site
La Roche - Sure-Yon, 85925
Research Site
Lille, 59000
Research Site
Montpellier, 34295
Research Site
Nantes, 44093
Research Site
Paris, 75015
Research Site
Paris, 75651
Research Site
Pessac, 33604
Research Site
Pierre-Bénite, 69310
Research Site
Rennes, 35033
Research Site
Rouen, 76038
Research Site
Saint-Priest-en-Jarez, 42270
Research Site
Strasbourg, 67098
Research Site
Toulouse, 31100
Research Site
Tours, 37000
Research Site
Vandœuvre-lès-Nancy, 54500
United States9 sites
Research Site
Boston, Massachusetts, 2215
Research Site
Chicago, Illinois, 60612
Research Site
Hackensack, New Jersey, 07601
Research Site
Houston, Texas, 77030
Research Site
New York, New York, 10021
Research Site
Niles, Illinois, 60714
Research Site
Peoria, Illinois, 61615
Research Site
Seattle, Washington, 98109
Research Site
Tampa, Florida, 33612
United Kingdom7 sites
Research Site
Cardiff, CF14 4XW
Research Site
Leeds, LS9 7TF
Research Site
Leicester, LE1 7RH
Research Site
Nottingham, NG5 1PB
Research Site
Oxford, 0X3 7LE
Research Site
Plymouth, PL6 8DH
Research Site
Southampton, SO16 6YD
Belgium5 sites
Research Site
Bruges, 8000
Research Site
Brussels, 1000
Research Site
Brussels, 1200
Research Site
Liège, 4000
Research Site
Yvoir, 5530
Italy4 sites
Research Site
Bologna, 40138
Research Site
Meldola, 47014
Research Site
Milan, 20132
Research Site
Novara, 28100
Australia3 sites
Research Site
Monash
Research Site
Sydney, 2139
Research Site
Wodonga, 3690
Netherlands3 sites
Research Site
Amsterdam, 1105 AZ
Research Site
Maastricht, 6202 AZ
Research Site
Rotterdam, 3062 PA
Poland3 sites
Research Site
Krakow, 30-727
Research Site
Lodz, 93-510
Research Site
Olsztyn, 10-228
About this study
Official title: An Open-label, Phase 2 Study of ACP-196 in Subjects With Mantle Cell Lymphoma
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).
Read the 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.
- Conditions
- Mantle Cell Lymphoma (MCL)
- Being tested
- ACP-196 (acalabrutinib)
- Keywords
- Bruton tyrosine kinase inhibitor, Btk, Mantle Cell Lymphoma, MCL, ACP-196, Acalabrutinib, ACE-LY-004, Calquence
- Medical subject headings
- Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACP-196 (acalabrutinib)Drug
| Study group | Role | What they receive |
|---|---|---|
| ACP-196 (acalabrutinib) Regimen 1 | Experimental | ACP-196 (acalabrutinib) Regimen 1 Receives: Drug: ACP-196 (acalabrutinib) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study start2 Mar 2015
- Primary completion4 Dec 2020
- Study completion6 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mantle Cell Lymphoma (MCL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acerta Pharma BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Acerta Pharma, Study director, 1-888-292-9613
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02213926
- Sponsor's protocol ID
- ACE-LY-004
- Other IDs
- 2023-509352-34-00, 2014-002117-28, 2014, 2023
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2014
- Last updated
- 4 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Publications
Wang M, Rule S, Zinzani PL, Goy A, Casasnovas O, Smith SD, Damaj G, Doorduijn J, Lamy T, Morschhauser F, Panizo C, Shah B, Davies A, Eek R, Dupuis J, Jacobsen E, Kater AP, Le Gouill S, Oberic L, Robak T, Covey T, Dua R, Hamdy A, Huang X, Izumi R, Patel P, Rothbaum W, Slatter JG, Jurczak W. Acalabrutinib in relapsed or refractory mantle cell lymphoma (ACE-LY-004): a single-arm, multicentre, phase 2 trial. Lancet. 2018 Feb 17;391(10121):659-667. doi: 10.1016/S0140-6736(17)33108-2. Epub 2017 Dec 11.
PubMed 29241979