Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Relapsed/Refractory Marginal Zone Lymphoma
Part of paid clinical trials in Tucson, Arizona.
- Sponsor
- Pharmacyclics LLC.
- Study ID
- NCT01980628
- Phase
- PHASE2
- Status
- Completed
Conditions
- B-cell Lymphoma
- Marginal Zone Lymphoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- ibrutinib — DRUG
Study Details
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).
Key Dates
- Start date
- Dec 31, 2013
- Status verified
- Oct 2019
- Primary completion
- Jul 31, 2016
- Completion
- Oct 2, 2017
Study Design
- Enrollment
- 63 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: ibrutinibibrutinib capsules: 560 mg once daily
Primary Outcome Measure
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. ]
Locations (13)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Site Reference ID/Investigator# 837 | Tucson | Arizona | 85719 | - |
| Site Reference ID/Investigator# 047 | Duarte | California | 91010 | - |
| Site Reference ID/Investigator# 377 | Santa Monica | California | 90095 | - |
| Site Reference ID/Investigator# 763 | West Palm Beach | Florida | 33401 | - |
| Site Reference ID/Investigator# 033 | Atlanta | Georgia | 30322 | - |
| Site Reference ID/Investigator# 370 | Chicago | Illinois | 60611 | - |
| Site Reference ID/Investigator# 195 | Detroit | Michigan | 48202 | - |
| Site Reference ID/Investigator# 350 | New Hyde Park | New York | 11042 | - |
| Site Reference ID/Investigator # 200 | New York | New York | 10065 | - |
| Site Reference ID/Investigator # 407 | New York | New York | 10065 | - |
| Site Reference ID/Investigator# 745 | New York | New York | 08724 | - |
| Site Reference ID/Investigator# 220 | Hershey | Pennsylvania | 17033 | - |
| Site Reference ID/Investigator# 348 | Seattle | Washington | 98109 | - |
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