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
:
Medizinische Klinik III, Telefon: 089440072551 Lmu
Indications
Classification Code Description
ICD-10-GM C83.1 Mantelzell-Lymphom
Trial design
World
Trial type
:
Interventional
World
Blinding type
:
Double blinded
World
Phase
:
III
Status
World
Status
:
Recruitment finished
Votes
World
Institutional review board - vote
:
Unknown
Initiiation & lock
World
Date of lock (planned / actual)
:
Unknown / Unknown
Therapy
World
Therapy line
:
1
Participants The lead of this trial has not explicitely given their approval for publishing the contact information of the principal investigators or specific contact persons.