Lymphoma

Rollover study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)

Incyte Study ID:
INCB 50465-801
CT.gov ID:
NCT04509700
Eudra ID:
2019-004948-30
EU CT Number:
2022-501687-18-00
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Recruitment Complete
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Clinical Study Purpose

This is a Phase 2, multicenter, open-label study to provide continued supply of parsaclisib as monotherapy or in combination therapy with itacitinib, ruxolitinib, or ibrutinib to participants from Incyte-sponsored studies of parsaclisib.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Lymphoma
    • PRODUCT
  • Drug: Parsaclisib
  • Drug: parsaclisib + itacitinib
  • Drug: parsaclisib + ruxolitinib
  • Drug: parsaclisib + ibrutinib
    • COLLABORATORS
    N/A
    DATE
    Aug 2020 - Sep 2027
    TYPE
    Interventional
    PHASE
    Phase 2
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    RCCA MD, LLC
    BETHESDA, MD, US, 20817
    Name
    UNIVERSITY HOSPITALS CASE MEDICAL CENTER
    CLEVELAND, OH, US, 44106
    Name
    UAB COMPREHENSIVE CANCER CENTER
    BIRMINGHAM, AL, US, 35233
    Name
    UNIVERSITY OF MICHIGAN CANCER CENTER
    ANN ARBOR, MI, US, 48109
    Name
    CLINIQUES UNIVERSITAIRES UCL SAINT-LUC
    BRUSSELS, Belgium, 01200
    Name
    CENTRE ANTOINE LACCASSAGNE
    NICE, France, 06189
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    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Currently enrolled and receiving treatment in an Incyte-sponsored clinical study of parsaclisib.
    • Currently tolerating treatment in the parent Protocol.

    Exclusion Criteria

    • Has been permanently discontinued from study treatment in the parent Protocol for any reason.
    • Able to access parsaclisib as monotherapy or in combination with itacitinib, ruxolitinib, or ibrutinib therapy outside a clinical study.
    Requirements information
    Inclusion Criteria
    • Currently enrolled and receiving treatment in an Incyte-sponsored clinical study of parsaclisib.
    • Currently tolerating treatment in the parent Protocol.
    • Currently receiving clinical benefit from treatment with parsaclisib as monotherapy or in combination therapy with Itacitinib, ruxolitinib, or ibrutinib as determined by the investigator.
    • Has at least stable disease, as determined by the investigator.
    • Has demonstrated compliance, as assessed by the investigator, with the parent Protocol requirements.
    • Willingness and ability to comply with scheduled visits, treatment plans, including PJP prophylaxis, and any other study procedures indicated in this Protocol.
    • Willingness to avoid pregnancy or fathering children
    • Ability to comprehend and willingness to sign an ICF
    Exclusion Criteria
    • Has been permanently discontinued from study treatment in the parent Protocol for any reason.
    • Able to access parsaclisib as monotherapy or in combination with itacitinib, ruxolitinib, or ibrutinib therapy outside a clinical study.
    • Participants with an uncontrolled intercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the participant or compliance with the Protocol.
    • Pregnant or breastfeeding women.

    Protocol Summary

    Incyte Study ID:
    INCB 50465-801
    Primary Purpose:
    Treatment
    Allocation:
    Non-randomized
    Study Design:
    Single Group Assignment
    Masking:
    None (Open Label)
    Interventions:
  • Drug: Parsaclisib
  • Drug: parsaclisib + itacitinib
  • Drug: parsaclisib + ruxolitinib
  • Drug: parsaclisib + ibrutinib
    • Enrollment:
    112
    Primary Outcome
    Open

    Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Timeframe: Through study completion, an average of 5 years

    Secondary Outcome
    Open
    Not Available