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

Last updated: October 5, 2023
Sponsor: Incyte Corporation
Overall Status: Active - Recruiting

Phase

2

Condition

B-cell Malignancies

Treatment

parsaclisib + ruxolitinib

parsaclisib + itacitinib

parsaclisib + ibrutinib

Clinical Study ID

NCT04509700
INCB 50465-801
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

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.

Study Design

Total Participants: 200
Treatment Group(s): 4
Primary Treatment: parsaclisib + ruxolitinib
Phase: 2
Study Start date:
August 03, 2020
Estimated Completion Date:
September 30, 2024

Study Description

The purpose of this study is to provide continued use of parsaclisib as monotherapy or in combination with itacitinib, ruxolitinib, or ibrutinib to participants who are currently enrolled in an Incyte-sponsored study and receiving the same treatment, who have at least stable disease, who are obtaining clinical benefit (in the opinion of the investigator) on the current study treatment, as defined by the parent Protocol, and who are unable to access parsaclisib as monotherapy or in combination with itacitinib, ruxolitinib, or ibrutinib outside a clinical study. Participants will continue on the same dose and schedule as the ones being administered in the Incyte- sponsored parent Protocol at the time of the rollover. The study will collect and assess safety information with regards to AEs.

Connect with a study center

  • Universitair Ziekenhuis Gent

    Gent, 09000
    Belgium

    Active - Recruiting

  • Aarhus University Hospital

    Aarhus, 08200
    Denmark

    Active - Recruiting

  • Hadassah Hebrew University Medical Center Ein Karem Hadassah

    Jerusalem, 91120
    Israel

    Active - Recruiting

  • Sheba Medical Center

    Tel Hashomer, 5265601
    Israel

    Active - Recruiting

  • Fondazione IRCCS Istituto Nazionale Dei Tumori

    Milano, 20133
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126
    Italy

    Active - Recruiting

  • Juntendo University Hospital

    Bunkyo-ku, 113-8431
    Japan

    Active - Recruiting

  • Tohoku University Hospital

    Sendai-Shi, 980-8574
    Japan

    Active - Recruiting

  • Nippon Medical School Hospital

    Tokyo, 113-8603
    Japan

    Active - Recruiting

  • Hospital Clinic I Provincial

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007
    Spain

    Active - Recruiting

  • Hospital Universitario Quironsalud Madrid

    Pozuelo De Alarcón, 28233
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen Del Rocio

    Sevilla, 41013
    Spain

    Active - Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Active - Recruiting

  • City of Hope National Medical Center

    Duarte, California 91010
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • University Hospitals Case Medical Center

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • HOSPITAL UNIVERSITARIO HM SANCHINARRO

    MADRID, 28050

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.