Lymphoma

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

Incyte Study ID:
INCB 39110-206
CT.gov ID:
NCT02760485
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463
Study Complete
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Clinical Study Purpose

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)

Clinical Study Summary

MEDICAL CONDITION(S)
  • Lymphoma
    • PRODUCT
  • Drug: itacitinib
  • Drug: ibrutinib
    • COLLABORATORS
    N/A
    DATE
    Dec 2016 - Jun 2022
    TYPE
    Interventional
    PHASE
    Phase 1/Phase 2
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Histologically documented diagnosis of DLBCL.
    • * Phase 1: any DLBCL subtype.

    Exclusion Criteria

    • Transformed DLBCL or DLBCL with coexistent histologies (eg, follicular or mucosa-associated lymphoid tissue lymphoma).
    • Primary mediastinal (thymic) large B-cell lymphoma.

    Clinical Study Locations

    Location
    Status
    Location
    Mayo Clinic Arizona
    Scottsdale, Arizona, US, 85259
    Status
    Completed
    Location
    City of Hope National Medical Center
    Duarte, California, US, 91010
    Status
    Completed
    Location
    Pacific Shores Medical Group
    Long Beach, California, US, 90813
    Status
    Completed
    Location
    LAC-USC Medical Center/Kenneth Norris Jr Cancer Hospital
    Los Angeles, California, US, 90033
    Status
    Completed
    Location
    Moores UC San Diego Cancer Center
    San Diego, California, US, 92093
    Status
    Completed
    Location
    Mount Sinai Comprehensive Cancer Center
    Miami Beach, Florida, US, 33140
    Status
    Completed

    Protocol Summary

    Incyte Study ID:
    INCB 39110-206
    Primary Purpose:
    Treatment
    Allocation:
    N/A
    Study Design:
    Single Group Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    33
    Primary Outcome
    Open

    Phase 1: Safety and tolerability as assessed by adverse events and changes in clinical and laboratory assessments

    Timeframe: Screening through 35 days after end of treatment, estimated to be 12 months

    Phase 2: Efficacy as assessed by objective response rate (ORR)

    Timeframe: Weeks 8, 16, and every 16 weeks thereafter, estimated to be 12 months

    Secondary Outcome
    Open

    Phase 1: Efficacy as assessed by objective response rate (ORR)

    Timeframe: Screening through 16 weeks

    Phase 2: Efficacy as assessed by duration of response (DOR)

    Timeframe: Weeks 8, 16, and every 16 weeks thereafter, estimated to be 12 months

    Phase 2: Durable response rate

    Timeframe: Screening through 16 weeks

    Phase 2: Efficacy as assessed by progression-free survival (PFS)

    Timeframe: Weeks 8, 16, and every 16 weeks thereafter, estimated to be 12 months

    Phase 2: Efficacy as assessed by overall survival (OS)

    Timeframe: Every 12 weeks, estimated to be 12 months

    Phase 2: Number of treatment-emergent adverse events

    Timeframe: Screening through 35 days after end of treatment, estimated to be 12 months