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

Primary Purpose

Mantle Cell Lymphoma (MCL)

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ACP-196 (acalabrutinib)
Sponsored by
Acerta Pharma BV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mantle Cell Lymphoma (MCL) focused on measuring Bruton tyrosine kinase inhibitor, Btk, Mantle Cell Lymphoma, MCL, ACP-196, Acalabrutinib, ACE-LY-004, Calquence

Eligibility Criteria

18 Years - 130 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ACP-196 (acalabrutinib) Regimen 1

Arm Description

ACP-196 (acalabrutinib) Regimen 1

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 5, 2014
Last Updated
August 22, 2023
Sponsor
Acerta Pharma BV
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1. Study Identification

Unique Protocol Identification Number
NCT02213926
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 Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2, 2015 (Actual)
Primary Completion Date
December 4, 2020 (Actual)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acerta Pharma BV

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mantle Cell Lymphoma (MCL)
Keywords
Bruton tyrosine kinase inhibitor, Btk, Mantle Cell Lymphoma, MCL, ACP-196, Acalabrutinib, ACE-LY-004, Calquence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACP-196 (acalabrutinib) Regimen 1
Arm Type
Experimental
Arm Description
ACP-196 (acalabrutinib) Regimen 1
Intervention Type
Drug
Intervention Name(s)
ACP-196 (acalabrutinib)
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR) of ACP-196 (Acalabrutinib) in Subjects With Previously Treated MCL.
Description
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.
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Acerta Pharma
Organizational Affiliation
1-888-292-9613
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Research Site
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
Research Site
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
2215
Country
United States
Facility Name
Research Site
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Research Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Research Site
City
Monash
Country
Australia
Facility Name
Research Site
City
Sydney
ZIP/Postal Code
2139
Country
Australia
Facility Name
Research Site
City
Wodonga
ZIP/Postal Code
3690
Country
Australia
Facility Name
Research Site
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Research Site
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Research Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Research Site
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Research Site
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Research Site
City
Prague
ZIP/Postal Code
100 34, CZ
Country
Czechia
Facility Name
Research Site
City
Angers
ZIP/Postal Code
49033
Country
France
Facility Name
Research Site
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Research Site
City
Clermond Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Research Site
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Research Site
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Research Site
City
Grenoble Cedex 09
ZIP/Postal Code
38043
Country
France
Facility Name
Research Site
City
La Roche - Sure-Yon
ZIP/Postal Code
85925
Country
France
Facility Name
Research Site
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Research Site
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Research Site
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Research Site
City
Paris cedex 13
ZIP/Postal Code
75651
Country
France
Facility Name
Research Site
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Research Site
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Research Site
City
Pierre-Benite
ZIP/Postal Code
69310
Country
France
Facility Name
Research Site
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Research Site
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Research Site
City
St Priest en Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
Research Site
City
Strasbourg Cedex
ZIP/Postal Code
67098
Country
France
Facility Name
Research Site
City
Toulouse
ZIP/Postal Code
31100
Country
France
Facility Name
Research Site
City
Tours
ZIP/Postal Code
37000
Country
France
Facility Name
Research Site
City
Vandoeuvre-les-Nancy
ZIP/Postal Code
54500
Country
France
Facility Name
Research Site
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Research Site
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Research Site
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
Research Site
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Research Site
City
Maastricht
ZIP/Postal Code
6202 AZ
Country
Netherlands
Facility Name
Research Site
City
Rotterdam
ZIP/Postal Code
3062 PA
Country
Netherlands
Facility Name
Research Site
City
Krakow
ZIP/Postal Code
30-510
Country
Poland
Facility Name
Research Site
City
Lodz
ZIP/Postal Code
93-510
Country
Poland
Facility Name
Research Site
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland
Facility Name
Research Site
City
Badalona
ZIP/Postal Code
8916
Country
Spain
Facility Name
Research Site
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Research Site
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
Research Site
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Research Site
City
Leicester
ZIP/Postal Code
LE1 7RH
Country
United Kingdom
Facility Name
Research Site
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Research Site
City
Oxford
ZIP/Postal Code
0X3 7LE
Country
United Kingdom
Facility Name
Research Site
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Research Site
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Citations:
PubMed Identifier
29241979
Citation
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.
Results Reference
derived
Links:
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=ACE-LY-004&attachmentIdentifier=174abcea-afd1-4e70-80f7-35b2ebf5ffdb&fileName=ACE-LY-004_CSP-redacted.pdf&versionIdentifier=
Description
redacted CSP
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=ACE-LY-004&attachmentIdentifier=d95872f9-fa74-4ce1-8ba3-a297d59adcc1&fileName=ACE-LY-004_CSR_Synopsis_redacted.pdf&versionIdentifier=
Description
redacted CSR Synopsis
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=ACE-LY-004&attachmentIdentifier=34251c79-b079-49d9-893d-ad2b1853f487&fileName=ACE-LY-004_SAP_redacted.pdf&versionIdentifier=
Description
redacted SAP

Learn more about this trial

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

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