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

Phase 2

Active, not recruiting

• Conditions: B-Cell Malignancies
• Interventions: Drug: Parsaclisib; Drug: parsaclisib + itacitinib; Drug: parsaclisib + ibrutinib; Drug: parsaclisib + ruxolitinib

• Registration Number: NCT04509700
• Lead Sponsor: Incyte Corporation

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-08-03
• Study First Submitted: 2020-08-10
• Study First Submitted QC: 2020-08-10
• Study First Posted: 2020-08-12
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-22
• Primary Completion: 2027-09-30
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 112

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
parsaclisib	Parsaclisib	Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib as that provided in the parent Protocol at the time of the rollover.
parsaclicib + itacitinib	parsaclisib + itacitinib	Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib and 100 mg of itacitinib as that provided in the parent Protocol at the time of the rollover.
parsaclisib + ibrutinib	parsaclisib + ibrutinib	Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib and 140 mg of ibrutinib as that provided in the parent Protocol at the time of the rollover.
parsaclisib + ruxolitinib	parsaclisib + ruxolitinib	Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib and the same dose of ruxolitinib that was provided in the parent Protocol at the time of the rollover.

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Through study completion, an average of 5 years	Number of participants with treatment-related AEs

Trial Locations

Locations (104)

Uab Comprehensive Cancer Center; 🇺🇸 Birmingham, Alabama, United States

University of Alabama At Birmingham; 🇺🇸 Birmingham, Alabama, United States

Mayo Clinic Rochester; 🇺🇸 Phoenix, Arizona, United States

University of Arizona Cancer Center-Out Pt.; 🇺🇸 Tucson, Arizona, United States

City of Hope National Medical Center; 🇺🇸 Duarte, California, United States

California Cancer Associates For Research and Excellence; 🇺🇸 Fresno, California, United States

Innovative Clinical Research Institute; 🇺🇸 Long Beach, California, United States

Rocky Mountain Cancer Center; 🇺🇸 Aurora, Colorado, United States

Rush University Medical Center-Consultants in Hematology; 🇺🇸 Chicago, Illinois, United States

University of Kansas Hospital Authority; 🇺🇸 Westwood, Kansas, United States

Rcca Md, Llc; 🇺🇸 Bethesda, Maryland, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Michigan Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States

Hattiesburg Clinic Hematology; 🇺🇸 Hattiesburg, Mississippi, United States

Saint Luke'S Hospital of Kansas City; 🇺🇸 Kansas City, Missouri, United States

Hca Midwest Health-Research Medical Center; 🇺🇸 Kansas City, Missouri, United States

Comprehensive Cancer Centers of Nevada; 🇺🇸 Las Vegas, Nevada, United States

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

University Hospitals Case Medical Center; 🇺🇸 Cleveland, Ohio, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

The Ohio State University; 🇺🇸 Columbus, Ohio, United States

Knight Cancer Institute At Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

Baylor Scott White Univeristy Medical Center; 🇺🇸 Dallas, Texas, United States

University of Washington-Seattle Cancer Care Alliance; 🇺🇸 Seattle, Washington, United States

Medical University of Vienna; 🇦🇹 Vienna, Austria

Cliniques Universitaires Ucl Saint-Luc; 🇧🇪 Brussels, Belgium

Universitair Ziekenhuis Gent (Uz Gent); 🇧🇪 Gent, Belgium

Az Groeninge; 🇧🇪 Kortrijk, Belgium

Universitaire Ziekenhuis Leuven - Gasthuisberg; 🇧🇪 Leuven, Belgium

University Hospital Hradec Kralove; 🇨🇿 Hradec Králové, Czechia

Univerzita Karlova V Praze 1. Lekarska Fakulta; 🇨🇿 Prague 2, Czechia

University Hospital Kralovkse Vinohrady; 🇨🇿 Praha 10, Czechia

Fakultni Nemocnice V Motole; 🇨🇿 Praha 5, Czechia

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Sjaellands Universitetshospital; 🇩🇰 Roskilde, Denmark

Aarhus University Hospital; 🇩🇰 Århus N, Denmark

Chru de Brest Hospital Morvan; 🇫🇷 Brest, France

Centre Antoine Laccassagne; 🇫🇷 Nice, France

Ap-Hp Groupe Hospitalier Saint-Louis Lariboisiere Fernand-Widal Site Saint Louis (Paris); 🇫🇷 Paris, France

Hospital Universitaire Pitie-Salpetriere; 🇫🇷 Paris, France

Centre Hospitalier Universitaire de Toulouse; 🇫🇷 Toulouse, France

Chru Hopitaux de Tours Hospital Bretonneau; 🇫🇷 Tours, France

Petz Aladar County Teaching Hospital; 🇭🇺 Gyor, Hungary

Hadassah Hebrew University Medical Center Ein Karem Hadassah; 🇮🇱 Jerusalem, Israel

Rabin Medical Center - Beilinson Hospital; 🇮🇱 Petach Tikva, Israel

Sheba Medical Center; 🇮🇱 Tel Hashomer, Israel

University of Bologna Institute of Haematology L E A Seragnoli; 🇮🇹 Bologna, Italy

Lstituto Di Ematologia Lorenzo Ea.Seragnoli Universita Degli Studi Di Bologna - Policlinico S. Or; 🇮🇹 Bologna, Italy

Azienda Ospedaliero-Universitaria Careggi (Aouc); 🇮🇹 Firenze, Italy

Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori; 🇮🇹 Meldola (fc), Italy

Fondazione Irccs Ca Granda Ospedale Maggiore; 🇮🇹 Milano, Italy

Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano; 🇮🇹 Milano, Italy

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda; 🇮🇹 Milano, Italy

Universita Di Napoli Federico Ii; 🇮🇹 Naples, Italy

Azienda Ospedaliero Universitaria Maggiore Della Carita Di Novara; 🇮🇹 Novara, Italy

Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello; 🇮🇹 Palermo, Italy

Azienda Ospedaliero Universitaria Pisana - Ospedale S. Chiara; 🇮🇹 Pisa, Italy

Ospedale Santa Maria Delle Croci; 🇮🇹 Ravenna, Italy

Ospedale Sant. Eugenio; 🇮🇹 Roma, Italy

Juntendo University Hospital; 🇯🇵 Bunkyo-ku, Japan

National Cancer Center Hospital; 🇯🇵 Chuo, Japan

Kansai Medical University Hospital; 🇯🇵 Hirakata, Japan

Tokai University Hospital; 🇯🇵 Isehara, Japan

Irb of Kobe City Medical Center General Hospital; 🇯🇵 Kobe, Japan

University Hospital Kyoto Prefectural University of Medicine; 🇯🇵 Kyoto, Japan

Nho Matsumoto Medical Center; 🇯🇵 Matsumoto-shi, Japan

Miyagi Cancer Center; 🇯🇵 Miyagi, Japan

Jrc Aichi Medical Center Nagoya Daini Hospital; 🇯🇵 Nagoya, Japan

Niigata Cancer Center Hospital; 🇯🇵 Niigata, Japan

Osaka Metropolitan University Hospital; 🇯🇵 Osaka, Japan

Hokuyukai Sapporo Hokuyu Hospital; 🇯🇵 Sapporo, Japan

National Hospital Org. Hokkaido Cancer Center; 🇯🇵 Sapporo, Japan

Tohoku University Hospital; 🇯🇵 Sendai-shi, Japan

Tokyo Medical University Hospital; 🇯🇵 Shinjuku, Japan

Tenri Hospital; 🇯🇵 Tenri, Japan

Nippon Medical School Hospital; 🇯🇵 Tokyo, Japan

Yokohama Municipal Citizens Hospital; 🇯🇵 Yokohama, Japan

University of Fukui Hospital; 🇯🇵 Yoshida-gun, Japan

The Catholic University of Korea Seoul St. Mary'S Hospital; 🇰🇷 Seoul, Korea, Republic of

Haukeland University Hospital; 🇳🇴 Bergen, Norway

Sp Zoz Szpital Uniwersytecki; 🇵🇱 Kracow, Poland

Wwcoit Im. M. Kopernika W Lodzi; 🇵🇱 Lodz, Poland

Szpital Specjalistyczny Im. Jedrzeja Sniadeckiego W Nowym Saczu; 🇵🇱 Nowy Sacz, Poland

Samodzielny Publiczny Szpital Kliniczny Nr 1; 🇵🇱 Wroclaw, Poland

Hospital General Unviersitario de Alicante; 🇪🇸 Alicante, Spain

Germans Trias I Pujol; 🇪🇸 Badalona, Spain

Hospital Del Mar; 🇪🇸 Barcelona, Spain

Hospital Clinic Barcelona; 🇪🇸 Barcelona, Spain

Hospital Clinic I Provincial; 🇪🇸 Barcelona, Spain

Start Madrid - Ciocc; 🇪🇸 Boadilla Del Monte, Spain

Institut Catala Doncologia - Hospital Duran I Reynals; 🇪🇸 L´hospitalet de Llobregat, Spain

Hospital General Universitario Gregorio Maranon; 🇪🇸 Madrid, Spain

Hospital Universitario Fundacin Jimnez Daz; 🇪🇸 Madrid, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Universitario Hm Sanchinarro; 🇪🇸 Madrid, Spain

Hospital Universitario Quironsalud Madrid; 🇪🇸 Pozuelo de Alarcon, Spain

Hospital Clinico Universitario de Salamanca; 🇪🇸 Salamanca, Spain

Hospital Universitario Virgen Del Rocio; 🇪🇸 Sevilla, Spain

Karolinska University Hospital Solna; 🇸🇪 Stockholm, Sweden

Istanbul Medipol Universitesi Ibagcilar Medipol Mega Universitesi Hastanesi; 🇹🇷 Istanbul, Turkey

Ege University Hospital; 🇹🇷 Izmir, Turkey

Birmingham Heartlands Hospital; 🇬🇧 Birmingham, United Kingdom