Lymphoma

INCB050465 in Combination With Rituximab, Bendamustine and Rituximab, or Ibrutinib in Participants With Previously Treated B-Cell Lymphoma (CITADEL-112)

Incyte Study ID:
INCB 50465-112 (CITADEL-112)
CT.gov ID:
NCT03424122
View Results Summary
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Study Complete
Subscribe to UpdatesContact Us

Clinical Study Purpose

The purpose of this study is to evaluate the safety and tolerability of parsaclisib when combined with rituximab, bendamustine and rituximab, or ibrutinib in participants with relapsed or refractory B-cell lymphoma.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Lymphoma
    • PRODUCT
  • Drug: Parsaclisib
  • Drug: Rituximab
  • Drug: Bendamustine
  • Drug: Ibrutinib
    • COLLABORATORS
    N/A
    DATE
    Jul 2018 - Jun 2022
    TYPE
    Interventional
    PHASE
    Phase 1
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    UNIVERSITY OF ARIZONA CANCER CENTER - OUT PT.
    TUSCON, AZ, US, 85719
    Name
    INDIANA BLOOD AND MARROW TRANSPLANTATION
    INDIANAPOLIS, IN, US, 46237
    Name
    COMPREHENSIVE CANCER CENTER OF NEVADA
    LAS VEGAS, NV, US, 89169
    Name
    TEXAS ONCOLOGY
    AUSTIN, TX, US, 78705
    Name
    BAYLOR CHARLES A. SAMMONS CANCER CENTER
    DALLAS, TX, US, 75246
    Name
    BAYLOR COLLEGE OF MEDICINE
    HOUSTON, TX, US, 77030

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Men and women, aged 18 years or older on the day of signing the Informed Consent Form (ICF).
    • Histologically confirmed indolent/aggressive DLBCL, FL, MZL, or MCL.

    Exclusion Criteria

    • Evidence of transformed non-Hodgkin lymphoma histologies (with the exception of FL).
    • Histologically confirmed rare non-Hodgkin B-cell subtypes.

    Protocol Summary

    Incyte Study ID:
    INCB 50465-112 (CITADEL-112)
    Primary Purpose:
    Treatment
    Allocation:
    Non-randomized
    Study Design:
    Parallel Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    50
    Primary Outcome
    Open

    Number of treatment-emergent adverse events (TEAEs)

    Timeframe: Up to approximately 12 months.

    Secondary Outcome
    Open

    Apparent clearance of parsaclisibin combination with rituximab, bendamustine and rituximab, or ibrutinib

    Timeframe: Up to approximately 1 month.

    Apparent volume of distribution of parsaclisib in combination with rituximab, bendamustine and rituximab, or ibrutinib

    Timeframe: Up to approximately 1 month.