Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Relapsed/Refractory Marginal Zone Lymphoma
This study is ongoing, but not recruiting participants.
Janssen Research & Development, LLC
Information provided by (Responsible Party):
First received: October 29, 2013
Last updated: May 30, 2017
Last verified: May 2017
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).
Marginal Zone Lymphoma
||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
||A Multicenter, Open-Label, Phase 2 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Subjects With Relapsed/Refractory Marginal Zone Lymphoma
Primary Outcome Measures:
- ORR (Overall Response Rate) [ Time Frame: Analysis was conducted with the cutoff date of 05 July 2016, with a median follow-up time of 19.4 months. ]
ORR is defined as the proportion of subjects who achieved complete response (CR), partial response (PR). Response criteria are as outlined in the International Working Group Criteria for NHL, Cheson (2007), with disease assessments performed by an independent review comittee (IRC).
CR is defined as disappearance of all evidence of disease. PR is defined as regression of measurable disease and no new sites.
Secondary Outcome Measures:
| Study Start Date:
| Estimated Study Completion Date:
| Primary Completion Date:
||July 2016 (Final data collection date for primary outcome measure)
ibrutinib capsules: 560 mg once daily
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.
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01980628
Janssen Research & Development, LLC
||Isaiah Dimery, MD
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 29, 2013
|Results First Received:
||December 20, 2016
||May 30, 2017
Keywords provided by Pharmacyclics LLC.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on June 23, 2017
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Immune System Diseases