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

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: ibrutinib
    ibrutinib 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)

FacilityCityStateZIPSite coordinators
Site Reference ID/Investigator# 837TucsonArizona85719-
Site Reference ID/Investigator# 047DuarteCalifornia91010-
Site Reference ID/Investigator# 377Santa MonicaCalifornia90095-
Site Reference ID/Investigator# 763West Palm BeachFlorida33401-
Site Reference ID/Investigator# 033AtlantaGeorgia30322-
Site Reference ID/Investigator# 370ChicagoIllinois60611-
Site Reference ID/Investigator# 195DetroitMichigan48202-
Site Reference ID/Investigator# 350New Hyde ParkNew York11042-
Site Reference ID/Investigator # 200New YorkNew York10065-
Site Reference ID/Investigator # 407New YorkNew York10065-
Site Reference ID/Investigator# 745New YorkNew York08724-
Site Reference ID/Investigator# 220HersheyPennsylvania17033-
Site Reference ID/Investigator# 348SeattleWashington98109-

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