Non Hodgkin Lymphoma Clinical Trial

A Study of INCB050465 in Relapsed or Refractory Follicular Lymphoma

Summary

The purpose of this study is to assess the objective response rate of parsaclisib treatment in participants with relapsed or refractory follicular lymphoma.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Aged 18 years or older.
Histologically confirmed, relapsed or refractory, follicular B-cell non-Hodgkin lymphoma (NHL) (follicular lymphoma) Grade 1, 2, and 3a.
Ineligible for hematopoietic stem cell transplant.
Must have been treated with at least 2 prior systemic therapies.
Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures > 1.5 cm in the longest dimension and ≥ 1.0 cm in the longest perpendicular dimension as assessed by computed tomography or magnetic resonance imaging.
Must be willing to undergo an incisional, excisional, or core needle lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue.
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

Exclusion Criteria:

Known histological transformation from indolent NHL to diffuse large B-cell lymphoma.
History of central nervous system lymphoma (either primary or metastatic).
Prior treatment with idelalisib, other selective phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitors, or a pan-PI3K inhibitor.
Prior treatment with a Bruton's tyrosine kinase inhibitor (eg, ibrutinib).
Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of study treatment administration.
Active graft-versus-host disease.
Participants positive for hepatitis B surface antigen or hepatitis B core antibody will be eligible if they are negative for hepatitis B virus-deoxyribonucleic acid (HBV-DNA). Participants positive for anti-hepatitis C virus (HCV) antibody will be eligible if they are negative for HCV-ribonucleic acid (RNA).

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

126

Study ID:

NCT03126019

Recruitment Status:

Active, not recruiting

Sponsor:

Incyte Corporation

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There are 83 Locations for this study

See Locations Near You

Arizona Oncology Associates - Biltmore Cancer Center
Phoenix Arizona, 85016, United States
Beverly Hills Cancer Center
Beverly Hills California, 90211, United States
Synergy Hematology and Oncology Medical Associates
Los Angeles California, 90036, United States
St. Joseph Heritage Healthcare
Santa Rosa California, 95403, United States
American Institute of Research Corporate Office
Whittier California, 90603, United States
Cancer Center of Central Connecticut
Southington Connecticut, 06489, United States
Florida Cancer Specialists & Research Institute
Fort Myers Florida, 33901, United States
Asclepes Research Centers
Spring Hill Florida, 34606, United States
Clinical Trials of Swla Llc
Lake Charles Louisiana, 70601, United States
Saint Agnes Hospital
Baltimore Maryland, 21229, United States
Barbara Ann Karmanos Cancer Hospital
Detroit Michigan, 48201, United States
Hattiesburg Clinic Hematology
Hattiesburg Mississippi, 39401, United States
Saint Luke'S Hospital
Kansas City Missouri, 64111, United States
Sarah Cannon Research Institute
Kansas City Missouri, 64132, United States
Clinical Research Alliance, Inc.
New Hyde Park New York, 11042, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Gabrail Cancer Center
Canton Ohio, 44718, United States
University of Pennsylvania Health System
Philadelphia Pennsylvania, 19104, United States
Charleston Hematology Oncology Associates Pa
Charleston South Carolina, 29414, United States
Tennessee Oncology
Nashville Tennessee, 37203, United States
Renovatio Clinical Consultants Llc
Spring Texas, 77380, United States
University of Washington
Seattle Washington, 98109, United States
Western Health
St Albans Victoria, 03021, Australia
Border Medical Oncology
Wodonga Victoria, 03690, Australia
St Vincent'S Hospital Sydney
Darlinghurst , 02010, Australia
Saint John Regional Hospital
St. John New Brunswick, E2L 4, Canada
Sunnybrook Health Science Centre
Toronto Ontario, M4N 3, Canada
Santa Cabrini Hospital
Montreal Quebec, H1T 1, Canada
University Hospital Hradec Kralove
Hradec Kralove , 500 0, Czechia
Fakultni Nemocnice Ostrava
Ostrava , 708 5, Czechia
University Hospital Kralovkse Vinohrady
Prague , 10034, Czechia
Fakultni Nemocnice V Motole
Praha 5 , 15000, Czechia
Univerzita Karlova V Praze 1. Lekarska Fakulta
Praha , 120 0, Czechia
Aalborg University Hospital
Aalborg , 09000, Denmark
Odense Universitetshospital (Ouh) (Odense University Hospital)
Odense C , 05000, Denmark
Bag Arnoldstr. Dresden
Dresden , 01307, Germany
University Medical Center Freiburg
Freiburg , 79106, Germany
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
Mainz , 55131, Germany
University Hospital Mannheim
Mannheim , 68167, Germany
Semmelweis Egyetem
Budapest , 01085, Hungary
National Institute of Oncology
Budapest , 01122, Hungary
University of Debrecen
Debrecen , 04032, Hungary
Somogy Medyei Kaposi Mor Oktato Korhaz
Kaposvar , 07400, Hungary
Hillel Yafe Medical Center (Hymc)
Hadera , 38100, Israel
Rambam Medical Center
Haifa , 31096, Israel
Laniado Hospital Hematology
Netanya , 42150, Israel
Sheba Medical Center
Ramat Gan , 52621, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv-yafo , 64239, Israel
Irccs Centro Di Riferimento Oncologico
Aviano , 33081, Italy
Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari
Bari , 70124, Italy
University of Bologna
Bologna , 40126, Italy
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori
Meldola , 47014, Italy
Ospedale San Raffaele
Milano , 20132, Italy
Fondazione Irccs Istituto Nazionale Dei Tumori
Milano , 20133, Italy
A.O.U. Di Modena - Policlinico
Modena , 41124, Italy
A.O.U. Federico Ii
Napoli , 80131, Italy
Aou Maggiore Della Carita
Novara , 28100, Italy
Ospedali Riuniti Villa Sofia Cervello
Palermo , 90146, Italy
Sapienza University
Rome , 00161, Italy
I.R.C.C.S. Casa Sollievo Della Sofferenza
San Giovanni Rotondo , 71013, Italy
Aou Citta Della Salute E Della Scienza Di Torino
Torino , 10126, Italy
San Bartolo Hospital
Vicenza , 36100, Italy
Uniwersyteckie Centrum Kliniczne
Gdansk , 80-95, Poland
Pratia McM Krakow
Krakow , 30-51, Poland
State Hospital Opole
Opole , 45-37, Poland
Institute of Hematology and Transfusion Medicine
Warszawa , 02-77, Poland
Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie
Warszawa , 02-78, Poland
Hospital de La Santa Creu I Sant Pau
Barcelona , 08026, Spain
Hospital General Universitari Vall D Hebron
Barcelona , 08035, Spain
Hgu Gregorio Maranon
Madrid , 28009, Spain
Md Anderson Cancer Centre Madrid
Madrid , 28033, Spain
Hospital Universitario Ramon Y Cajal
Madrid , 28034, Spain
Hospital Universitario de La Paz
Madrid , 28046, Spain
Hospital Universitario Hm Sanchinarro
Madrid , 28050, Spain
Hospital Universitario Quironsalud Madrid
Madrid , 28223, Spain
Hospital Universitario de Canarias
San Cristobal de La Laguna , 38320, Spain
Hospital Universitario Virgen Macarena
Sevilla , 41007, Spain
Hospital Universitario Virgen Del Rocio
Sevilla , 41013, Spain
Karolinska University Hospital, Huddinge
Stockholm , 14141, Sweden
Birmingham Heartlands Hospital
Birmingham , B9 5S, United Kingdom
Northwick Park Hospital
London , SE5 9, United Kingdom
Royal Hallamshire Hospital
Sheffield , S10 2, United Kingdom
The Royal Marsden Nhs Foundation Trust - Chelsea
Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

126

Study ID:

NCT03126019

Recruitment Status:

Active, not recruiting

Sponsor:


Incyte Corporation

How clear is this clinincal trial information?

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