Study of Acalabrutinib Alone or in Combination Therapy in Subjects With B-cell Non-Hodgkin Lymphoma

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Acerta Pharma BV
Study ID
NCT02180711
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Non Hodgkin Lymphoma

Eligibility Criteria

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

Interventions

Study Details

Part 1: To characterize the safety profile of acalabrutinib alone or in combination with rituximab in subjects with R/R FL. Part 2: To characterize the activity of acalabrutinib alone or in combination with rituximab in subjects with R/R MZL, as measured by ORR. Part 3: To characterize the safety of acalabrutinib in combination with rituximab and lenalidomide in subjects with R/R FL

Key Dates

First listed
Jul 3, 2014
Start date
Dec 29, 2014
Status verified
Jun 2026
Primary completion
Aug 25, 2023
Completion
Dec 11, 2028

Study Design

Enrollment
113 participants (actual)
Allocation
NA
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: acalabrutinib Regimen 1
    acalabrutinib Regimen 1 for relapsed, refractory Follicular Lymphoma subjects
  • Experimental: Part 1: acalabrutinib Regimen 2
    acalabrutinib Regimen 2 + rituximab for relapsed, refractory, or treatment naive Follicular Lymphoma subjects
  • Experimental: Part 2: acalabrutinib Regimen 1
    acalabrutinib Regimen 1 for relapsed, refractory Marginal Zone Lymphoma subjects
  • Experimental: Part 2: acalabrutinib Regimen 2
    acalabrutinib Regimen 2 + rituximab for relapsed, refractory Marginal Zone Lymphoma subjects
  • Experimental: Part 3: acalabrutinib Regimen 1
    acalabrutinib Regimen + lenalidomide + rituximab for relapsed, refractory Follicular Lymphoma subjects

Primary Outcome Measure

Part 1: Incidence of Treatment-emergent Adverse Events. [ Time Frame: From the first dose of study drug until study discontinuation, 30 days after the last dose of study drug or one day before the first subsequent anticancer therapy, whichever was earlier, up to 80.7 months (the maximum participant's time on this study). ]

Locations (23)

FacilityCityStateZIPSite coordinators
Research SiteTucsonArizona85719-
Research SiteDowneyCalifornia90241-
Research SiteDuarteCalifornia91010-
Research SiteFountain ValleyCalifornia92708-
Research SiteSanta MonicaCalifornia90404-
Research SiteCoral Gables FLFlorida33146-
Research SiteChicagoIllinois60611-
Research SiteChicagoIllinois60612-
Research SiteChicagoIllinois60637-
Research SiteLouisvilleKentucky40207-
Research SiteNew OrleansLouisiana70112-
Research SiteAnn ArborMichigan48109-
Research SiteMorristownNew Jersey07960-
Research SiteLake SuccessNew York11042-
Research SiteNew YorkNew York10021-
Research SiteColumbusOhio43210-
Research SiteGreenvilleSouth Carolina29615-
Research SiteDallasTexas75235-
Research SiteHoustonTexas77030-
Research SiteSan AntonioTexas78217-
Research SiteTempleTexas76508-
Research SiteSalt Lake CityUtah84112-
Research SiteSpokaneWashington99208-

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