Lymphoma

A Study of INCB050465 in Relapsed or Refractory Follicular Lymphoma

Incyte Study ID:
INCB 50465-203 (CITADEL-203)
CT.gov ID:
NCT03126019
View Results Summary
Eudra ID:
2017-001624-22
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Study Complete
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Results Available

Protocol
Available Languages: English
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Statistical Analysis Plan (SAP)
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Clinical Study Purpose

The purpose of this study is to assess the objective response rate of parsaclisib treatment in participants with relapsed or refractory follicular lymphoma.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Lymphoma
    • PRODUCT
  • Drug: Parsaclisib
    • COLLABORATORS
    N/A
    DATE
    Mar 2018 - Feb 2021
    TYPE
    Interventional
    PHASE
    Phase 2
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    BEVERLY HILLS CANCER CENTER
    BEVERLY HILLS, CA, US, 90211
    Name
    ST. JOSEPH HERITAGE HEALTHCARE
    SANTA ROSA, CA, US, 95403
    Name
    AMERICAN INSTITUTE OF RESEARCH CORPORATE OFFICE
    WHITTIER, CA, US, 90603
    Name
    CLINICAL TRIALS OF SWLA LLC
    LAKE CHARLES, LA, US, 70601
    Name
    SAINT AGNES HOSPITAL
    BALTIMORE, MD, US, 21229
    Name
    BARBARA ANN KARMANOS CANCER HOSPITAL
    DETROIT, MI, US, 48201

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Aged 18 years or older.
    • Histologically confirmed, relapsed or refractory, follicular B-cell non-Hodgkin lymphoma (NHL) (follicular lymphoma) Grade 1, 2, and 3a.

    Exclusion Criteria

    • Known histological transformation from indolent NHL to diffuse large B-cell lymphoma.
    • History of central nervous system lymphoma (either primary or metastatic).

    Protocol Summary

    Incyte Study ID:
    INCB 50465-203 (CITADEL-203)
    Primary Purpose:
    Treatment
    Allocation:
    Non-randomized
    Study Design:
    Sequential Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    126
    Primary Outcome
    Open

    Objective response rate with parsaclisib based on Lugano classification response criteria

    Timeframe: Weeks 8, 16, and 24, then every 12 weeks through Week 96, and then every 24 Weeks thereafter until disease progression, up to approximately 12 months.

    Secondary Outcome
    Open

    Complete response rate with parsaclisib based on Lugano classification response criteria

    Timeframe: Up to approximately 12 months per subject

    Duration of response

    Timeframe: Up to approximately 24 months per subject

    Progression-free survival with parsaclisib

    Timeframe: Up to approximately 24 months per subject (approximately 12 months for median)

    Overall survival with parsaclisib

    Timeframe: Up to approximately 24 months per subject

    Safety and tolerability of parsaclisib measured by adverse events (AEs)

    Timeframe: Baseline through 30-35 days after end of treatment, up to approximately 12 months per subject