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

Last updated: April 21, 2025
Sponsor: Incyte Corporation
Overall Status: Active - Not Recruiting

Phase

2

Condition

B-cell Malignancies

Neoplasms

Treatment

parsaclisib + ibrutinib

parsaclisib + ruxolitinib

parsaclisib + itacitinib

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 ofparsaclisib.

  • Currently tolerating treatment in the parent Protocol.

  • Currently receiving clinical benefit from treatment with parsaclisib as monotherapyor in combination therapy with Itacitinib, ruxolitinib, or ibrutinib as determinedby the investigator.

  • Has at least stable disease, as determined by the investigator.

  • Has demonstrated compliance, as assessed by the investigator, with the parentProtocol requirements.

  • Willingness and ability to comply with scheduled visits, treatment plans, includingPJP 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 forany 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 conditionthat, in the investigator's opinion, would jeopardize the safety of the participantor compliance with the Protocol.

  • Pregnant or breastfeeding women.

Study Design

Total Participants: 112
Treatment Group(s): 4
Primary Treatment: parsaclisib + ibrutinib
Phase: 2
Study Start date:
August 03, 2020
Estimated Completion Date:
September 30, 2027

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

  • Medical University of Vienna

    Vienna, 01090
    Austria

    Site Not Available

  • Cliniques Universitaires Ucl Saint-Luc

    Brussels, 01200
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Gent

    Gent, 09000
    Belgium

    Active - Recruiting

  • Universitair Ziekenhuis Gent (Uz Gent)

    Gent, 09000
    Belgium

    Site Not Available

  • Az Groeninge

    Kortrijk, 08500
    Belgium

    Site Not Available

  • Universitaire Ziekenhuis Leuven - Gasthuisberg

    Leuven, 03000
    Belgium

    Site Not Available

  • University Hospital Hradec Kralove

    Hradec Králové, 50005
    Czechia

    Site Not Available

  • Univerzita Karlova V Praze 1. Lekarska Fakulta

    Prague 2, 128 00
    Czechia

    Site Not Available

  • University Hospital Kralovkse Vinohrady

    Praha 10,
    Czechia

    Site Not Available

  • Fakultni Nemocnice V Motole

    Praha 5, 15000
    Czechia

    Site Not Available

  • Aarhus University Hospital

    Aarhus,
    Denmark

    Site Not Available

  • Rigshospitalet

    Copenhagen, 02100
    Denmark

    Site Not Available

  • The Finsen Centre National Hospital

    Copenhagen, 02100
    Denmark

    Active - Recruiting

  • Zealand University Hospital

    Kã¸ge, DK-4600
    Denmark

    Site Not Available

  • Zealand University Hospital

    K�GE, DK-4600
    Denmark

    Site Not Available

  • Zealand University Hospital

    Køge, DK-4600
    Denmark

    Site Not Available

  • Sjaellands Universitets Hospital Roskilde

    Roskilde, 04000
    Denmark

    Active - Recruiting

  • Sjaellands Universitetshospital

    Roskilde, 04000
    Denmark

    Site Not Available

  • Zealand University Hospital

    Roskilde, DK-4600
    Denmark

    Site Not Available

  • Aarhus University Hospital

    Århus N, 08200
    Denmark

    Site Not Available

  • Chru de Brest Hospital Morvan

    Brest, 29200
    France

    Site Not Available

  • Centre Antoine Lacassagne

    Nice, 06189
    France

    Active - Recruiting

  • Centre Antoine Laccassagne

    Nice, 06189
    France

    Site Not Available

  • Ap-Hp Groupe Hospitalier Saint-Louis Lariboisiere Fernand-Widal Site Saint Louis (Paris)

    Paris, 75010
    France

    Site Not Available

  • Hospital Universitaire Pitie-Salpetriere

    Paris, 75013
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Toulouse

    Toulouse, 31059
    France

    Site Not Available

  • Chru Hopitaux de Tours Hospital Bretonneau

    Tours, 37000
    France

    Site Not Available

  • Petz Aladar County Teaching Hospital

    Gyor, 09024
    Hungary

    Site Not Available

  • Hadassah Hebrew University Medical Center Ein Karem Hadassah

    Jerusalem, 91120
    Israel

    Site Not Available

  • Rabin Medical Center - Beilinson Hospital

    Petach Tikva, 49100
    Israel

    Site Not Available

  • Sheba Medical Center

    Tel Hashomer, 5265601
    Israel

    Site Not Available

  • Lstituto Di Ematologia Lorenzo Ea.Seragnoli Universita Degli Studi Di Bologna - Policlinico S. Or

    Bologna, 40138
    Italy

    Site Not Available

  • University of Bologna Institute of Haematology L E A Seragnoli

    Bologna, 40126
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria Careggi (Aouc)

    Firenze, 50134
    Italy

    Site Not Available

  • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori

    Meldola (fc), 47014
    Italy

    Site Not Available

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milano, 20162
    Italy

    Site Not Available

  • Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano

    Milano, 20133
    Italy

    Site Not Available

  • Fondazione Irccs Ca Granda Ospedale Maggiore

    Milano, 20122
    Italy

    Site Not Available

  • Universita Di Napoli Federico Ii

    Naples, 80131
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Maggiore Della Carita Di Novara

    Novara, 28100
    Italy

    Site Not Available

  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

    Palermo, 90146
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Pisana - Ospedale S. Chiara

    Pisa, 56126
    Italy

    Site Not Available

  • Ospedale Santa Maria Delle Croci

    Ravenna, 48121
    Italy

    Site Not Available

  • Ospedale Sant. Eugenio

    Roma, 00144
    Italy

    Site Not Available

  • Juntendo University Hospital

    Bunkyo-ku, 113-8431
    Japan

    Site Not Available

  • National Cancer Center Hospital

    Chuo, 104-0045
    Japan

    Site Not Available

  • Kansai Medical University Hospital

    Hirakata, 573-1191
    Japan

    Site Not Available

  • Tokai University Hospital

    Isehara, 259-1193
    Japan

    Site Not Available

  • Irb of Kobe City Medical Center General Hospital

    Kobe, 650-0047
    Japan

    Site Not Available

  • Kobe City Medical Center General Hospital

    Kobe, 650-0047
    Japan

    Active - Recruiting

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, 602-8566
    Japan

    Site Not Available

  • Nho Matsumoto Medical Center

    Matsumoto-shi, 399-8701
    Japan

    Site Not Available

  • Miyagi Cancer Center

    Miyagi, 981-1293
    Japan

    Site Not Available

  • Jrc Aichi Medical Center Nagoya Daini Hospital

    Nagoya, 466-8650
    Japan

    Site Not Available

  • Niigata Cancer Center Hospital

    Niigata, 951-8566
    Japan

    Site Not Available

  • Osaka Metropolitan University Hospital

    Osaka, 545-8585
    Japan

    Site Not Available

  • Hokuyukai Sapporo Hokuyu Hospital

    Sapporo, 003-0006
    Japan

    Site Not Available

  • National Hospital Org. Hokkaido Cancer Center

    Sapporo, 003-0804
    Japan

    Site Not Available

  • Tohoku University Hospital

    Sendai-shi, 980-8574
    Japan

    Site Not Available

  • Tokyo Medical University Hospital

    Shinjuku, 160-0023
    Japan

    Site Not Available

  • Tenri Hospital

    Tenri, 632-8552
    Japan

    Site Not Available

  • Nippon Medical School Hospital

    Tokyo, 113-8603
    Japan

    Site Not Available

  • Yokohama Municipal Citizens Hospital

    Yokohama, 221-0855
    Japan

    Site Not Available

  • University of Fukui Hospital

    Yoshida-gun, 910-1193
    Japan

    Site Not Available

  • The Catholic University of Korea Seoul St. Mary'S Hospital

    Seoul, 06591
    Korea, Republic of

    Site Not Available

  • Haukeland University Hospital

    Bergen, 05021
    Norway

    Site Not Available

  • Sp Zoz Szpital Uniwersytecki

    Kracow, 31-501
    Poland

    Site Not Available

  • Wwcoit Im. M. Kopernika W Lodzi

    Lodz, 93-513
    Poland

    Site Not Available

  • Szpital Specjalistyczny Im. Jedrzeja Sniadeckiego W Nowym Saczu

    Nowy Sacz, 33-300
    Poland

    Site Not Available

  • Samodzielny Publiczny Szpital Kliniczny Nr 1

    Wroclaw, 20-081
    Poland

    Site Not Available

  • Hospital General Unviersitario de Alicante

    Alicante, 03010
    Spain

    Site Not Available

  • *Germans Trias I Pujol

    Badalona, 08916
    Spain

    Active - Recruiting

  • Germans Trias I Pujol

    Badalona, 08916
    Spain

    Site Not Available

  • Ico Hospital Germans Trias I Pujol

    Badalona, 08916
    Spain

    Active - Recruiting

  • Hospital Clinic Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Clinic I Provincial

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Del Mar

    Barcelona, 08003
    Spain

    Site Not Available

  • Start Madrid - Ciocc

    Boadilla Del Monte, 28660
    Spain

    Site Not Available

  • Institut Catala Doncologia - Hospital Duran I Reynals

    L´hospitalet de Llobregat, 08908
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28009
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario Fundacin Jimnez Daz

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario Hm Sanchinarro

    Madrid, 28050
    Spain

    Site Not Available

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcon, 28233
    Spain

    Site Not Available

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007
    Spain

    Site Not Available

  • Hospital Universitario Virgen Del Rocio

    Sevilla, 41013
    Spain

    Site Not Available

  • Karolinska University Hospital Solna

    Stockholm, 171 76
    Sweden

    Site Not Available

  • Istanbul Medipol Universitesi Ibagcilar Medipol Mega Universitesi Hastanesi

    Istanbul, 34214
    Turkey

    Site Not Available

  • Ege University Hospital

    Izmir, 35040
    Turkey

    Site Not Available

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS
    United Kingdom

    Site Not Available

  • Uab Comprehensive Cancer Center

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • University of Alabama At Birmingham

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Mayo Clinic Rochester

    Phoenix, Arizona 85054
    United States

    Site Not Available

  • University of Arizona Cancer Center - Out Pt.

    Tucson, Arizona 85719
    United States

    Site Not Available

  • University of Arizona Cancer Center-Out Pt.

    Tucson, Arizona 85719
    United States

    Site Not Available

  • City of Hope National Medical Center

    Duarte, California 31010
    United States

    Site Not Available

  • California Cancer Associates For Research and Excellence

    Fresno, California 93720
    United States

    Site Not Available

  • Innovative Clinical Research Institute

    Long Beach, California 90805
    United States

    Site Not Available

  • Rocky Mountain Cancer Center

    Aurora, Colorado 80012
    United States

    Site Not Available

  • Rush University Medical Center - Consultants in Hematology

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Rush University Medical Center-Consultants in Hematology

    Chicago, Illinois 60612
    United States

    Site Not Available

  • University of Kansas Hospital Authority

    Westwood, Kansas 66205
    United States

    Site Not Available

  • Rcca Md, Llc

    Bethesda, Maryland 20817
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • University of Michigan Cancer Center

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • University of Michigan Health System

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Hattiesburg Clinic Hematology

    Hattiesburg, Mississippi 39401
    United States

    Site Not Available

  • Hca Midwest Health-Research Medical Center

    Kansas City, Missouri 66211
    United States

    Site Not Available

  • Saint Luke'S Hospital of Kansas City

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada 89169
    United States

    Site Not Available

  • Roswell Park Cancer Institute

    Buffalo, New York 14263
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • University Hospitals Case Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Knight Cancer Institute At Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Sarah Cannon Research Institute

    Franklin, Tennessee 37067
    United States

    Site Not Available

  • Baylor Scott White Univeristy Medical Center

    Dallas, Texas 75246
    United States

    Site Not Available

  • University of Washington - Seattle Cancer Care Alliance

    Seattle, Washington 98109-4405
    United States

    Site Not Available

  • University of Washington-Seattle Cancer Care Alliance

    Seattle, Washington 98109-4405
    United States

    Site Not Available

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