Public trial registry of the CCC-Munich

Trial ACE-LY-308

Trial Trial design Status In-/Exclusion Therapy Participants Documents Permissions Tumorboards

Trial
World
Trial acronym
:
ACE-LY-308
World
Full 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

World
Description
:

This clinical trial is a Phase 3, randomized, double-blind, placebo-controlled, multicenter
study evaluating acalabrutinib plus BR compared with placebo plus BR in subjects with
previously untreated MCL.
Approximately 546 subjects meeting the eligibility criteria for the study will be randomized
1:1

World
EudraCT number
:
World
Responsible organization
:
KUM Med3 - Medizinische Klinik und Poliklinik III Lmu
Indications
Classification Code Description
ICD-O-3 9673/3 Mantelzell-Lymphom
Trial design
World
Trial type
:
Interventional
World
Blinding type
:
Double blinded
World
Phase
:
III
Status
World
Status
:
Recruitment active
Votes
World
Institutional review board - vote
:
Positive
World
BfArM - vote
:
Positive
Initiiation & lock
World
Date of lock (planned / actual)
:
Unknown / Unknown
Therapy
World
Therapy line
:
1
World
Therapy
:

Arm 1: Acalabrutinib administered 100 mg twice per day (BID) orally (PO) plus
bendamustine 90 mg/m2 intravenously (IV) on Days 1 and 2 and rituximab 375 mg/m2 IV on
Day 1; cycles are repeated every 28 days.

Arm 2: Matching placebo administered BID PO plus bendamustine 90 mg/m2 IV on Days 1
and 2 and rituximab 375 mg/m2 IV on Day 1; cycles are repeated every 28 days.

Participants
Function Prename Surname Organization
World Principal Investigator Martin Dreyling Klinikum der Universität München Magnifier
World Responsible contact Martin Dreyling Klinikum der Universität München Magnifier
World Sponsor Acerta Pharma Magnifier