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

B-Cell Malignancies Clinical Trial

Official title:

A Phase 2, Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04509700
• Other study ID #: INCB 50465-801
• Status: Recruiting
• Phase: Phase 2
• Start date: August 3, 2020
• Est. completion date: September 30, 2024

Study information

• Verified date: May 2024
• Source: Incyte Corporation
• Contact: Incyte Corporation Call Center (US)
• Phone: 1.855.463.3463
• Email: medinfo[@]incyte.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• B-Cell Malignancies
• Neoplasms

Intervention

Drug:
• 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.
• 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 + 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.
• 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.

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna
Belgium	Cliniques Universitaires Ucl Saint-Luc	Brussels
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	Az Groeninge	Kortrijk
Belgium	Universitaire Ziekenhuis Leuven - Gasthuisberg	Leuven
Czechia	University Hospital Hradec Kralove	Hradec Králové
Czechia	Univerzita Karlova V Praze 1. Lekarska Fakulta	Prague 2
Czechia	Univerzita Karlova V Praze 1. Lekarska Fakulta	Prague 2
Czechia	University Hospital Kralovkse Vinohrady	Praha 10
Czechia	University Hospital Kralovkse Vinohrady	Praha 10
Czechia	Fakultni Nemocnice V Motole	Praha 5
Denmark	Aarhus University Hospital	Århus N
Denmark	Rigshospitalet	Copenhagen
Denmark	Sjaellands Universitetshospital	Roskilde
France	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
Hungary	Petz Aladar County Teaching Hospital	Gyor
Israel	Hadassah Hebrew University Medical Center Ein Karem Hadassah	Jerusalem
Israel	Rabin Medical Center - Beilinson Hospital	Petach Tikva
Israel	Sheba Medical Center	Tel Hashomer
Italy	Lstituto Di Ematologia Lorenzo Ea.Seragnoli Universita Degli Studi Di Bologna - Policlinico S. Or	Bologna
Italy	University of Bologna Institute of Haematology L E A Seragnoli	Bologna
Italy	Azienda Ospedaliero-Universitaria Careggi (Aouc)	Firenze
Italy	Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori	Meldola (fc)
Italy	Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda	Milano
Italy	Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano	Milano
Italy	Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano	Milano
Italy	Fondazione Irccs Ca Granda Ospedale Maggiore	Milano
Italy	Universita Di Napoli Federico Ii	Naples
Italy	Azienda Ospedaliero Universitaria Maggiore Della Carita Di Novara	Novara
Italy	Azienda Ospedaliero Universitaria Maggiore Della Carita Di Novara	Novara
Italy	Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello	Palermo
Italy	Azienda Ospedaliero Universitaria Pisana	Pisa
Italy	Ospedale Santa Maria Delle Croci	Ravenna
Italy	Ospedale Sant. Eugenio	Roma
Japan	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
Korea, Republic of	The Catholic University of Korea Seoul St. Mary'S Hospital	Seoul
Norway	Haukeland University Hospital	Bergen
Poland	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
Spain	Hospital General Unviersitario de Alicante	Alicante
Spain	Germans Trias I Pujol	Badalona
Spain	Hospital Clinic Barcelona	Barcelona
Spain	Hospital Clinic I Provincial	Barcelona
Spain	Hospital Del Mar	Barcelona
Spain	Start Madrid - Ciocc	Boadilla Del Monte
Spain	Hospital General Universitario Gregorio Maranon	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Fundacin Jimnez Daz	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
Sweden	Karolinska University Hospital Solna	Stockholm
Turkey	Istanbul Medipol Universitesi Ibagcilar Medipol Mega Universitesi Hastanesi	Istanbul
Turkey	Ege University Hospital	Izmir
United Kingdom	Birmingham Heartlands Hospital	Birmingham
United States	University of Michigan Cancer Center	Ann Arbor	Michigan
United States	University of Michigan Cancer Center	Ann Arbor	Michigan
United States	Rocky Mountain Cancer Center	Aurora	Colorado
United States	Rcca Md, Llc	Bethesda	Maryland
United States	Uab Comprehensive Cancer Center	Birmingham	Alabama
United States	University of Alabama At Birmingham	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Rush University Medical Center-Consultants in Hematology	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	The Ohio State University	Columbus	Ohio
United States	Baylor Scott White Univeristy Medical Center	Dallas	Texas
United States	City of Hope National Medical Center	Duarte	California
United States	Duke University Medical Center	Durham	North Carolina
United States	California Cancer Associates For Research and Excellence	Fresno	California
United States	Hattiesburg Clinic Hematology	Hattiesburg	Mississippi
United States	Hca Midwest Health-Research Medical Center	Kansas City	Missouri
United States	Saint Luke'S Hospital of Kansas City	Kansas City	Missouri
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Innovative Clinical Research Institute	Long Beach	California
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Mayo Clinic Rochester	Phoenix	Arizona
United States	Knight Cancer Institute At Oregon Health and Science University	Portland	Oregon
United States	University of Washington-Seattle Cancer Care Alliance	Seattle	Washington
United States	University of Arizona Cancer Center-Out Pt.	Tucson	Arizona
United States	University of Kansas Hospital Authority	Westwood	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Czechia,  Denmark,  France,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Norway,  Poland,  Spain,  Sweden,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Number of participants with treatment-related AEs	Through study completion, an average of 5 years