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A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02972840
Recruitment Status : Recruiting
First Posted : November 25, 2016
Last Update Posted : March 15, 2023
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Acerta Pharma BV

Study Description
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Brief Summary:
This study is evaluating the efficacy of acalabrutinib in combination with bendamustine and rituximab (BR) compared with placebo plus BR in subjects with previously untreated mantle cell lymphoma.

Condition or disease Intervention/treatment Phase
Lymphoma, Mantle Cell Drug: Acalabrutinib Drug: Bendamustine Drug: Rituximab Drug: Placebo Phase 3

Detailed Description:
To evaluate the efficacy of acalabrutinib in combination with bendamustine and rituximab (BR) compared with placebo plus BR based on Independent Review Committee (IRC) assessment of progression-free survival (PFS) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL) in subjects with previously untreated mantle cell lymphoma (MCL).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 546 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Bendamustine and Rituximab (BR) Alone Versus in Combination With Acalabrutinib (ACP-196) in Subjects With Previously Untreated Mantle Cell Lymphoma
Actual Study Start Date : April 5, 2017
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : February 28, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Acalabrutinib in combination with bendamustine and rituximab
Acalabrutinib administered twice per day (BID) orally (PO) plus bendamustine on Days 1 and 2 and rituximab on Day 1; cycles are repeated every 28 days.
 Drug: Acalabrutinib
Administered orally (PO)
Other Names:
  • ACP-196
  • Calquence

Drug: Bendamustine
Administered intravenously (IV)
Other Names:
  • Treanda
  • Bendeka

Drug: Rituximab
Administered intravenously (IV)
Other Names:
  • Rituxan
  • Rituxan Hycela
Placebo Comparator: Placebo in combination with bendamustine and rituximab
Matching placebo administered BID PO plus bendamustine on Days 1 and 2 and rituximab on Day 1; cycles are repeated every 28 days.
 Drug: Bendamustine
Administered intravenously (IV)
Other Names:
  • Treanda
  • Bendeka

Drug: Rituximab
Administered intravenously (IV)
Other Names:
  • Rituxan
  • Rituxan Hycela

Drug: Placebo
Placebo comparator


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free survival per the Lugano Classification for NHL in Arm 1 compared to Arm 2 [ Time Frame: Up to 6 years ]
    Defined as the time from the date of randomization until disease progression (assessed by the IRC per the Lugano Classification for NHL) or death from any cause, whichever occurs first.


Secondary Outcome Measures :
  1. Investigator-assessed progression-free survival per the Lugano Classification for NHL in Arm 1 compared to Arm 2 [ Time Frame: Up to 6 years ]
    Defined as the time from the date of randomization until disease progression (assessed by the investigator per the Lugano Classification for NHL) or death from any cause, whichever occurs first.

  2. Investigator-assessed overall response rate per the Lugano Classification for NHL in Arm 1 compared to Arm 2 [ Time Frame: Up to 6 years ]
    Defined as the proportion of subjects who achieve either partial response (PR) or complete response (CR) as best overall response according to the Lugano Classification for NHL as assessed by investigator.

  3. IRC-assessed overall response rate per the Lugano Classification for NHL in Arm 1 compared to Arm 2 [ Time Frame: Up to 6 years ]
    Defined as the proportion of subjects who achieve either PR or CR as best overall response according to the Lugano Classification for NHL as assessed by IRC.

  4. Overall survival in Arm 1 compared to Arm 2 [ Time Frame: Up to 6 years ]
    Defined as the time from randomization until the date of death from any cause.

  5. IRC-assessed duration of response per the Lugano Classification for NHL in Arm 1 compared to Arm 2 [ Time Frame: Up to 6 years ]
    Defined as the time from the first documentation of CR or PR to disease progression per the Lugano Classification for NHL or death from any cause, whichever occurs first.

  6. IRC assessed time to response per the Lugano Classification for NHL in Arm 1 compared to Arm 2 [ Time Frame: Up to 6 years ]
    Defined as the time from randomization to the first CR or PR per the Lugano Classification for NHL.


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women, ≥ 65 years of age.
  • Pathologically confirmed MCL, with documentation of a chromosome translocation t(11;14)(q13;q32) and/or overexpression of cyclin D1 in association with other relevant markers (eg, CD5, CD19, CD20, PAX5) .
  • MCL requiring treatment and for which no prior systemic anticancer therapies have been received.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
  • Agreement to use highly effective forms of contraception during the study and 6 months after the last dose of bendamustine, or 12 months after the last dose of rituximab, whichever is longest .

Exclusion Criteria:

  • Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of first dose of study drug, 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 (calculated using Friderica's formula: QT/RR0.33) at screening. Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study.
  • Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
  • Uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment), or intravenous anti infective treatment within 2 weeks before first dose of study drug.
  • Concurrent participation in another therapeutic clinical trial.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02972840


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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Sponsors and Collaborators
Acerta Pharma BV
AstraZeneca
More Information
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Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT02972840    
Other Study ID Numbers: ACE-LY-308
First Posted: November 25, 2016    Key Record Dates
Last Update Posted: March 15, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
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.
Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified 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 athttps://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Acerta Pharma BV:
Bruton tyrosine kinase inhibitor
Acalabrutinib
Mantle Cell Lymphoma
ACE-LY-308
 Treatment naive
non-Hodgkins Lymphoma
Bendomustine
Rituximab
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
 Bendamustine Hydrochloride
Acalabrutinib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action