SCCA Lymphoma Clinical Trials
|Recruiting||Marginal Zone Lymphoma
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).
Ibrutinib is a first-in-class, potent, orally administered covalent inhibitor of Bruton's tyrosine kinase (BTK). Inhibition of BTK blocks downstream B-cell receptor (BCR) signaling pathways and thus prevents B-cell proliferation. In vitro, ibrutinib inhibits purified BTK and selected members of the kinase family with 10-fold specificity compared with non-BTK kinases. Phase 1 and 2 studies of ibrutinib in B-cell malignancies demonstrate modest toxicity and significant single agent activity in a variety of B-cell malignancies, including NHL.
- Histologically documented marginal zone lymphoma (including splenic, nodal, and extranodal sub-types)
- Previously received one or more lines of therapy including one CD20-directed chemoimmunotherapy regimen 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 disease 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.
- Life expectancy of >3 months, in the opinion of the investigator
- 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, external beam radiation therapy, or anticancer antibodies within 21 days of the first dose of study drug
- Concurrent use of warfarin or other vitamin K antagonists
- Concurrent use of a strong CYP3A4/5 inhibitor
- 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
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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