Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib.

Part of paid clinical trials in Burbank, California.

Sponsor
Pharmacyclics Switzerland GmbH
Study ID
NCT03229200
Phase
PHASE4
Status
Active Not Recruiting

Conditions

  • Graft Vs Host Disease
  • Leukemia, B-cell
  • Lymphoma, B-Cell
  • Lymphoma, Non-Hodgkin
  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ibrutinib — DRUG
    Subjects will continue with the current ibrutinib dosing regimen established in the parent ibrutinib study.

Study Details

Multicenter, open-label, prospective treatment protocol that provides continued access to ibrutinib to subjects who have completed parent ibrutinib studies, are still benefitting from treatment with ibrutinib, and have no access to commercial ibrutinib for their underlying disease within their region.

Key Dates

Start date
May 22, 2017
Status verified
Oct 2025
Primary completion
May 10, 2027
Completion
May 10, 2027

Study Design

Enrollment
297 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ibrutinib
    Treatment with Ibrutinib, once daily until disease progression or unacceptable toxicity.

Primary Outcome Measure

Characterize the drug safety profile by collecting long-term safety data for ibrutinib. [ Time Frame: Up to 3 years and will be re-evaluated on an ongoing basis. ]

Locations (34)

FacilityCityStateZIPSite coordinators
Providence Health System - Southern California d/b/a Roy and Patricia Disney Family Cancer Center, The Roy & Patricia Disney Family Cancer CenterBurbankCalifornia91505-
City Of Hope National Medical CenterDuarteCalifornia91010-
UCSD Moores Cancer CenterLa JollaCalifornia92093-0698-
University of California Los Angeles (UCLA)Los AngelesCalifornia90095-
Stanford UniversityStanfordCalifornia94305-
Emory UniversityAtlantaGeorgia30322-
Northwestern UniversityChicagoIllinois60611-
University of ChicagoChicagoIllinois60637-
Norton Medical Plaza II, 3991 Dutchmans LaneLouisvilleKentucky40207-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Henry Ford Health SystemDetroitMichigan48202-
TRIO - Comprehensive Cancer Centers of NevadaLas VegasNevada89169-3321-
John Theurer Cancer Center, Hackensack UMCHackensackNew Jersey07601-
San Juan Oncology AssociatesFarmingtonNew Mexico87401-
Northwell HealthNew Hyde ParkNew York11042-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-6007-
Weill Cornell Medical College-New York Presbyterian HospitalNew YorkNew York10065-
University of RochesterRochesterNew York14642-
Levine Cancer InstituteCharlotteNorth Carolina28204-
Southeastern Medical Oncology CenterGoldsboroNorth Carolina27534-9479-
University of Cincinnati Medical CenterCincinnatiOhio45267-
Cleveland ClinicClevelandOhio44195-
Mid Ohio Oncology/Hematology Inc., DBA The Mark H. Zangmeister CenterColumbusOhio43219-
The Ohio State UniversityColumbusOhio43210-
University of Pennsylvania Abramson Cancer CenterPhiladelphiaPennsylvania19104-
Vanderbilt Ingram Cancer CenterNashvilleTennessee37232-
M.D. Anderson Cancer CentreHoustonTexas77030-
University of Texas MD Anderson Cancer CenterHoustonTexas77030-4009-
US Oncology Research, LLCThe WoodlandsTexas77380-
University of Vermont Medical CenterBurlingtonVermont05405-
Swedish Cancer InstituteSeattleWashington98104-
Northwest Cancer Specialists, Compass OncologyVancouverWashington09868-
Wenatchee Valley Hospital and ClinicsWenatcheeWashington98801-
Yakima Valley Memorial HospitalYakimaWashington98902-

Find similar trials in Burbank, CA

By research site
Providence Health System - Southern California d/b/a Roy and Patricia Disney Family Cancer Center, The Roy & Patricia Disney Family Cancer Center· Burbank, CACity Of Hope National Medical Center· Duarte, CAUCSD Moores Cancer Center· La Jolla, CAUniversity of California Los Angeles (UCLA)· Los Angeles, CAStanford University· Stanford, CAEmory University· Atlanta, GA

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