Lymphoma

Open-Label Study of Parsaclisib, in Japanese Participants With Relapsed or Refractory Follicular Lymphoma (CITADEL-213)

Incyte Study ID:
INCB 50465-213
CT.gov ID:
NCT04434937
View Results Summary
Eudra ID:
N/A
Sponsor:
Incyte Biosciences Japan GK
Collaborator:
N/A
Study Contact Information:
+81 3-3507-5795 or [email protected]
Study Complete
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Results Available

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

The purpose of this study is to assess the efficacy and safety of parsaclisib in Japanese participants with relapsed or refractory follicular lymphoma

Clinical Study Summary

MEDICAL CONDITION(S)
  • Lymphoma
    • PRODUCT
  • Drug: parsaclisib
    • COLLABORATORS
    N/A
    DATE
    Sep 2020 - Feb 2023
    TYPE
    Interventional
    PHASE
    Phase 2
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    NATIONAL HOSPITAL ORGANIZATION NAGOYA MEDICAL CENTER
    NAGOYA, Japan, 460-0001
    Name
    Red Cross Nagoya Daini Hospital
    Nagoya, Japan, 4668650
    Name
    NHO SHIKOKU CANCER CENTER
    MATSUYAMA, Japan, 791-0280
    Name
    NIIGATA CANCER CENTER HOSPITAL
    NIIGATA, Japan, 951-8566
    Name
    KOBE CITY MEDICAL CENTER GENERAL HOSPITAL
    KOBE, Japan, 650-0047
    Name
    UNIVERSITY HOSPITAL KYOTO PREFECTURAL UNIVERSITY OF MEDICINE
    KYOTO, Japan, 602-8566

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Male or female Japanese participant who must be ≥ 18 years of age
    • Ability to comprehend and willingness to sign a written ICF and comply with all study visits and procedures

    Exclusion Criteria

    • Known histological transformation from indolent NHL to DLBCL
    • History of central nervous system lymphoma (either primary or metastatic)

    Protocol Summary

    Incyte Study ID:
    INCB 50465-213
    Primary Purpose:
    Treatment
    Allocation:
    N/A
    Study Design:
    Single Group Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    42
    Primary Outcome
    Open

    Objective response rate (ORR)

    Timeframe: Up to approximately 2 years

    Secondary Outcome
    Open

    Complete response rate (CRR)

    Timeframe: Up to approximately 2 years

    Duration of response (DOR)

    Timeframe: Up to approximately 2 years

    Progression-free survival (PFS)

    Timeframe: Up to approximately 2 years

    Overall survival

    Timeframe: Up to approximately 2 years

    Best percentage change in target lesion size

    Timeframe: Up to approximately 2 years

    Number of participants with treatment-emergent adverse events (TEAEs)

    Timeframe: Up to approximately 2 years