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NCT Number: NCT02972840

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Lymphoma, Mantle Cell Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Buenos Aires, Argentina

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acalabrutinib

Drug

Administered orally (PO)

Other names: ACP-196, Calquence

Bendamustine

Drug

Administered intravenously (IV)

Other names: Treanda, Bendeka

Rituximab

Drug

Administered intravenously (IV)

Other names: Rituxan, Rituxan Hycela

Placebo

Drug

Placebo comparator

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Acerta Pharma BV

Industry

Collaborators

  • AstraZeneca

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Nov 25, 2016
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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