Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Relapsed/Refractory Marginal Zone Lymphoma
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| ClinicalTrials.gov Identifier: NCT01980628 |
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Recruitment Status :
Completed
First Posted : November 11, 2013
Results First Posted : February 10, 2017
Last Update Posted : October 16, 2019
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Sponsor:
Pharmacyclics LLC.
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Pharmacyclics LLC.
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Brief 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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Marginal Zone Lymphoma B-cell Lymphoma | Drug: ibrutinib | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 63 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Multicenter, Open-Label, Phase 2 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Subjects With Relapsed/Refractory Marginal Zone Lymphoma |
| Study Start Date : | December 2013 |
| Actual Primary Completion Date : | July 2016 |
| Actual Study Completion Date : | October 2, 2017 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Lymphoma
Drug Information
available for:
Ibrutinib
| Arm | Intervention/treatment |
|---|---|
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Experimental: ibrutinib
ibrutinib capsules: 560 mg once daily
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Drug: ibrutinib
Other Name: PCI-32765 |
Primary Outcome Measures :
- ORR (Overall Response Rate) [ Time Frame: Analysis was conducted with the cutoff date of 02 Nov 2017, with a median follow-up time of 33.1 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 committee (IRC).
Per Cheson:
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 :
- DOR (Duration of Response) [ Time Frame: Analysis was conducted with the cutoff date of 02 Nov 2017, with a median follow-up time of 33.1 months. ]The DOR analyses is performed on the subset of subjects that achieve CR or PR as determined by IRC. DOR is calculated as the duration of time from the date of first response to the date of progression or death due to any cause.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01980628
Locations
Show 25 study locations
Sponsors and Collaborators
Pharmacyclics LLC.
Janssen Research & Development, LLC
Investigators
| Study Director: | Isaiah Dimery, MD | Pharmacyclics LLC. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Pharmacyclics LLC. |
| ClinicalTrials.gov Identifier: | NCT01980628 |
| Other Study ID Numbers: |
PCYC-1121-CA |
| First Posted: | November 11, 2013 Key Record Dates |
| Results First Posted: | February 10, 2017 |
| Last Update Posted: | October 16, 2019 |
| Last Verified: | October 2019 |
Keywords provided by Pharmacyclics LLC.:
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MZL NHL SMZL NMZL MALT |
Additional relevant MeSH terms:
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Lymphoma Lymphoma, B-Cell, Marginal Zone Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Lymphoma, B-Cell Lymphoma, Non-Hodgkin Ibrutinib Tyrosine Kinase Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |