Single-arm, phase II clinical trial of patients with Extranodal Marginal Zone Lymphoma
(EMZL). It is planned to recruit 130 patients.
Additional patients with Splenic Marginal Zone Lymphoma (SMZL), up to 30, and Nodal Marginal
Zone Lymphoma (NMZL), up to 15, will be included in the trial in order to preliminary explore
the clinical activity and safety of the combination treatment proposed.
The study primary endpoints will be analysed on the EMZL population. Outcome of patients with
SMZL and NMZL will be analysed and reported separately
Marginal zone lymphomas (MZL) represent a group of indolent B-cell lymphomas that arises from
marginal zone B-cells in extranodal tissues, such as spleen and mucosa associated lymphoid
tissues, and more rarely also in nodal tissues. MZL comprises 5 to 17% of all non-Hodgkin
lymphomas (NHL) in adults. The 2016 World Health Organization (WHO) recognized three separate
subtypes of MZL according to their primary localization, namely the:
extranodal MZL (EMZL) of mucosa-associated lymphoid tissue (MALT), also known as MALT
splenic MZL (SMZL)
nodal MZL (NMZL). These three subtypes are distinct disease entities that are classified
together because they all seem to originate from post germinal centre marginal zone
MALIBU trial is a prospective multicenter trial combining rituximab and ibrutinib in
front-line for patients with MZL, including EMZL, SMZL and NMZL Aim of the study is to assess
the safety and efficacy of the combination of rituximab and ibrutinib in EMZL patients and to
explore its activity in SMZL and NMZL as exploratory subset.
Marginal Zone Lymphoma, Nodal Marginal Zone Lymphoma, Splenic Marginal Zone Lymphoma
Clinical Study Identifier
International Extranodal Lymphoma Study Group (IELSG)
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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