Clinical Trials /

A Study of Bendamustine and Rituximab Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated Mantle Cell Lymphoma

NCT02972840

Description:

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.

Related Conditions:
  • Mantle Cell Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study of Bendamustine and Rituximab Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated Mantle Cell Lymphoma
  • 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

Clinical Trial IDs

  • ORG STUDY ID: ACE-LY-308
  • NCT ID: NCT02972840

Conditions

  • Lymphoma, Mantle Cell

Interventions

DrugSynonymsArms
Acalabrutinib in combination with bendamustine and rituximabAcalabrutinib in combination with bendamustine and rituximab
Placebo in combination with bendamustine and rituximabPlacebo in combination with bendamustine and rituximab

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Acalabrutinib in combination with bendamustine and rituximabExperimentalAcalabrutinib 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.
  • Acalabrutinib in combination with bendamustine and rituximab
Placebo in combination with bendamustine and rituximabPlacebo ComparatorMatching placebo administered BID PO plus bendamustine on Days 1 and 2 and rituximab on Day 1; cycles are repeated every 28 days.
  • Placebo in combination with bendamustine and rituximab

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:65 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression-free survival per the Lugano Classification for NHL in Arm 1 compared to Arm 2
Time Frame:48 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Investigator-assessed progression-free survival per the Lugano Classification for NHL in Arm 1 compared to Arm 2
Time Frame:48 months
Safety Issue:
Description:
Measure:Investigator-assessed overall response rate per the Lugano Classification for NHL in Arm 1 compared to Arm 2
Time Frame:48 months
Safety Issue:
Description:
Measure:IRC-assessed overall response rate per the Lugano Classification for NHL in Arm 1 compared to Arm 2
Time Frame:48 months
Safety Issue:
Description:
Measure:Overall survival in Arm 1 compared to Arm 2
Time Frame:48 months
Safety Issue:
Description:
Measure:IRC-assessed duration of response per the Lugano Classification for NHL in Arm 1 compared to Arm 2
Time Frame:48 months
Safety Issue:
Description:
Measure:IRC assessed time to response per the Lugano Classification for NHL in Arm 1 compared to Arm 2
Time Frame:48 months
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Acerta Pharma BV

Trial Keywords

  • Bruton tyrosine kinase inhibitor
  • Acalabrutinib
  • Mantle Cell Lymphoma
  • ACE-LY-308
  • Treatment naive
  • non-Hodgkins Lymphoma
  • Bendomustine
  • Rituximab

Last Updated

December 18, 2019