A Study of Itacitinib (INCB039110) in Combination With Ibrutinib in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Incyte Corporation
Study ID
NCT02760485
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • itacitinib — DRUG
    Phase 1 will evaluate itacitinib at the protocol-specified starting dose, with a possible increase or decrease depending on tolerability. Phase 2 will evaluate the recommended dose determined in Phase 1.
  • ibrutinib — DRUG

Study Details

The purpose of this study is to evaluate the safety/tolerability and efficacy of itacitinib in combination with ibrutinib in subjects with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)

Key Dates

Start date
Dec 29, 2016
Status verified
Jun 2023
Primary completion
Jun 6, 2022
Completion
Jun 6, 2022

Study Design

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

Arms

  • Experimental: itacitinib + ibrutinib

Primary Outcome Measure

Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) [ Time Frame: up to 285 days ]

Locations (21)

FacilityCityStateZIPSite coordinators
Mayo Clinic ArizonaScottsdaleArizona85259-
City of Hope National Medical CenterDuarteCalifornia91010-
Pacific Shores Medical GroupLong BeachCalifornia90813-
LAC-USC Medical Center/Kenneth Norris Jr Cancer HospitalLos AngelesCalifornia90033-
Moores UC San Diego Cancer CenterSan DiegoCalifornia92093-
Mount Sinai Comprehensive Cancer CenterMiami BeachFlorida33140-
Georgia Regents Research InstituteAugustaGeorgia30912-
University of Maryland Cancer CenterBaltimoreMaryland21201-
University of Michigan Cancer CenterAnn ArborMichigan48109-
Michigan State University Breslin Cancer CenterLansingMichigan48910-
St Vincent Frontier Cancer CenterBillingsMontana59102-
Comprehensive Cancer Center of NevadaLas VegasNevada89169-
Regional Cancer Center Associates, LLCLittle SilverNew Jersey07739-
Roswell Cancer CenterBuffaloNew York14263-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Toledo Clinic Cancer CentersToledoOhio43623-
Tulsa Cancer CenterTulsaOklahoma74146-
Geisinger Medical CenterDanvillePennsylvania17822-
University of Pennsylvania Health SystemPhiladelphiaPennsylvania19104-
Houston Methodist Cancer CenterHoustonTexas77030-
Northwest Medical Specialists & Research InstitutePuyallupWashington98373-

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