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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Untre

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.

Detailed Summary:
Sponsor: Acerta Pharma BV

Current Primary Outcome: Progression-free survival per the Lugano Classification for NHL in Arm 1 compared to Arm 2 [ Time Frame: 48 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Acerta Pharma BV

Dates:
Date Received: November 21, 2016
Date Started: February 2017
Date Completion: April 2023
Last Updated: March 28, 2017
Last Verified: March 2017