Clinical trial NCT04509700: Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: B-Cell Malignancies
Keywords: non-Hodgkin lymphoma
phosphatidylinositol 3-kinase
myeloproliferative neoplasm
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2020-08-12
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Through study completion, an average of 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Uab Comprehensive Cancer Center
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama At Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Mayo Clinic Rochester
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Cancer Center-Out Pt.
state: Arizona
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Fresno
country: United States
facility: California Cancer Associates For Research and Excellence
state: California
city: Long Beach
country: United States
facility: Innovative Clinical Research Institute
state: California
city: Aurora
country: United States
facility: Rocky Mountain Cancer Center
state: Colorado
city: Chicago
country: United States
facility: Rush University Medical Center-Consultants in Hematology
state: Illinois
city: Westwood
country: United States
facility: University of Kansas Hospital Authority
state: Kansas
city: Bethesda
country: United States
facility: Rcca Md, Llc
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Cancer Center
state: Michigan
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic Hematology
state: Mississippi
city: Kansas City
country: United States
facility: Saint Luke'S Hospital of Kansas City
state: Missouri
city: Kansas City
country: United States
facility: Hca Midwest Health-Research Medical Center
state: Missouri
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Portland
country: United States
facility: Knight Cancer Institute At Oregon Health and Science University
state: Oregon
city: Dallas
country: United States
facility: Baylor Scott White Univeristy Medical Center
state: Texas
city: Seattle
country: United States
facility: University of Washington-Seattle Cancer Care Alliance
state: Washington
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Brussels
country: Belgium
facility: Cliniques Universitaires Ucl Saint-Luc
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent (Uz Gent)
city: Kortrijk
country: Belgium
facility: Az Groeninge
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuis Leuven - Gasthuisberg
city: Hradec Králové
country: Czechia
facility: University Hospital Hradec Kralove
city: Prague 2
country: Czechia
facility: Univerzita Karlova V Praze 1. Lekarska Fakulta
city: Praha 10
country: Czechia
facility: University Hospital Kralovkse Vinohrady
city: Praha 5
country: Czechia
facility: Fakultni Nemocnice V Motole
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Roskilde
country: Denmark
facility: Sjaellands Universitetshospital
city: Århus N
country: Denmark
facility: Aarhus University Hospital
city: Brest
country: France
facility: Chru de Brest Hospital Morvan
city: Nice
country: France
facility: Centre Antoine Laccassagne
city: Paris
country: France
facility: Ap-Hp Groupe Hospitalier Saint-Louis Lariboisiere Fernand-Widal Site Saint Louis (Paris)
city: Paris
country: France
facility: Hospital Universitaire Pitie-Salpetriere
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire de Toulouse
city: Tours
country: France
facility: Chru Hopitaux de Tours Hospital Bretonneau
city: Gyor
country: Hungary
facility: Petz Aladar County Teaching Hospital
city: Jerusalem
country: Israel
facility: Hadassah Hebrew University Medical Center Ein Karem Hadassah
city: Petach Tikva
country: Israel
facility: Rabin Medical Center - Beilinson Hospital
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
city: Bologna
country: Italy
facility: University of Bologna Institute of Haematology L E A Seragnoli
city: Bologna
country: Italy
facility: Lstituto Di Ematologia Lorenzo Ea.Seragnoli Universita Degli Studi Di Bologna - Policlinico S. Or
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi (Aouc)
city: Meldola (fc)
country: Italy
facility: Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori
city: Milano
country: Italy
facility: Fondazione Irccs Ca Granda Ospedale Maggiore
city: Milano
country: Italy
facility: Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano
city: Milano
country: Italy
facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
city: Milano
country: Italy
facility: Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano
city: Naples
country: Italy
facility: Universita Di Napoli Federico Ii
city: Novara
country: Italy
facility: Azienda Ospedaliero Universitaria Maggiore Della Carita Di Novara
city: Palermo
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana - Ospedale S. Chiara
city: Ravenna
country: Italy
facility: Ospedale Santa Maria Delle Croci
city: Roma
country: Italy
facility: Ospedale Sant. Eugenio
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
city: Chuo
country: Japan
facility: National Cancer Center Hospital
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital
city: Isehara
country: Japan
facility: Tokai University Hospital
city: Kobe
country: Japan
facility: Irb of Kobe City Medical Center General Hospital
city: Kyoto
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine
city: Matsumoto-shi
country: Japan
facility: Nho Matsumoto Medical Center
city: Miyagi
country: Japan
facility: Miyagi Cancer Center
city: Nagoya
country: Japan
facility: Jrc Aichi Medical Center Nagoya Daini Hospital
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital
city: Osaka
country: Japan
facility: Osaka Metropolitan University Hospital
city: Sapporo
country: Japan
facility: Hokuyukai Sapporo Hokuyu Hospital
city: Sapporo
country: Japan
facility: National Hospital Org. Hokkaido Cancer Center
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital
city: Shinjuku
country: Japan
facility: Tokyo Medical University Hospital
city: Tenri
country: Japan
facility: Tenri Hospital
city: Tokyo
country: Japan
facility: Nippon Medical School Hospital
city: Yokohama
country: Japan
facility: Yokohama Municipal Citizens Hospital
city: Yoshida-gun
country: Japan
facility: University of Fukui Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St. Mary'S Hospital
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Kracow
country: Poland
facility: Sp Zoz Szpital Uniwersytecki
city: Lodz
country: Poland
facility: Wwcoit Im. M. Kopernika W Lodzi
city: Nowy Sacz
country: Poland
facility: Szpital Specjalistyczny Im. Jedrzeja Sniadeckiego W Nowym Saczu
city: Wroclaw
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1
city: Alicante
country: Spain
facility: Hospital General Unviersitario de Alicante
city: Badalona
country: Spain
facility: Germans Trias I Pujol
city: Barcelona
country: Spain
facility: Hospital Del Mar
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial
city: Boadilla Del Monte
country: Spain
facility: Start Madrid - Ciocc
city: L´hospitalet de Llobregat
country: Spain
facility: Institut Catala Doncologia - Hospital Duran I Reynals
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Universitario Fundacin Jimnez Daz
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario Hm Sanchinarro
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Universitario Quironsalud Madrid
city: Salamanca
country: Spain
facility: Hospital Clinico Universitario de Salamanca
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Solna
city: Istanbul
country: Turkey
facility: Istanbul Medipol Universitesi Ibagcilar Medipol Mega Universitesi Hastanesi
city: Izmir
country: Turkey
facility: Ege University Hospital
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
Study officials:
References: