Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Relapsed/Refractory Marginal Zone Lymphoma
Condition: Marginal Zone Lymphoma; B-cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell, Marginal Zone
Intervention: ibrutinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: MZL; NHL; SMZL; NMZL; MALT

Summary:

      Phase 2, open-label, non-randomized, monotherapy study to evaluate the safety and efficacy of
      ibrutinib in subject with relapsed/refractory Marginal Zone Lymphoma (MZL).
    

Eligibility criteria:

        Key Inclusion criteria:

          -  Histologically documented marginal zone lymphoma including splenic, nodal, and
             extranodal sub-types; subjects with splenic MZL must have an additional measurable
             lesion, nodal or extranodal, as described in inclusion criteria 5

          -  Previously received one or more lines of therapy including at least one CD20-directed
             regimen (either as monotherapy or as chemoimmunotherapy) with documented failure to
             achieve at least PR or documented PD after, the most recent systemic treatment regimen

          -  Men and women ≥18 years of age

          -  ECOG performance status of ≤2

          -  ≥1 measurable lesion site on CT scan (>1.5 cm in longest dimension). Lesions in
             anatomical locations (such as extremities or soft tissue lesions) that are not well
             visualized by CT may be measured by MRI instead. (Subjects with spleen-only disease
             are considered as not having measurable disease.)

          -  Life expectancy of >3 months, in the opinion of the investigator

        Key Exclusion criteria:

          -  Medically apparent CNS lymphoma or leptomeningeal disease

          -  History of other malignancies except adequately treated non melanoma skin cancer,
             curatively treated in-situ cancer, or other solid tumors curatively treated with no
             evidence of disease for ≥2 years

          -  History of allogeneic stem-cell (or other organ) transplantation

          -  Any chemotherapy, anticancer antibodies, or other systemic anticancer therapy within
             21 days of the first dose of study drug

          -  Any external beam radiation therapy within 6 weeks prior to the first dose of the
             study drug

          -  Concurrent use of warfarin or other vitamin K antagonists

          -  Concurrent use of a strong CYP3A inhibitor. Subjects who have received a strong CYP3A
             inhibitor prior to entering the study must have discontinued therapy for at least 5
             half lives of the prohibited medication.

          -  Recent infection requiring IV anti-infective treatment that was completed ≤14 days
             before the first dose of study drug

          -  Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved
             to CTCAE Grade 0 or 1, or to the levels dictated in the eligibility criteria with the
             exception of alopecia

          -  Inadequate organ function as defined on laboratory tests