A Study of INCB050465 in Relapsed or Refractory Follicular Lymphoma

NCT03126019 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: INCB 50465-203 (CITADEL-203)Parsaclisib2017-001624-22
• Study Type: interventional
• Target: 126
• Locations: 13 countries
• Sites: 83

Brief Summary

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

Conditions

Lymphoma

Keywords

Follicular lymphoma; non-Hodgkin lymphoma (NHL); phosphatidylinositol 3-kinase (PI3K) δ inhibitor

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate With Parsaclisib Based on Lugano Classification Response Criteria

  ORR=percentage of participants with complete response(CR) or partial response(PR) per revised response criteria for lymphomas,determined by independent review committee(IRC).Criteria for CR:1.Target nodes/nodal masses of lymph nodes,extralymphatic sites regressed to≤1.5cm in longest dimension transverse diameter of lesion(LDi);2.Absence of non-measured lesion;3.Organ enlargement regressed to normal;4.No new lesions;5.Normal bone marrow morphology;if indeterminate,immunohistochemistry negative.Criteria for PR:1.Lymph nodes,extralymphatic sites- ≥50%decrease in sum of product of perpendicular diameters for multiple lesions(SPD)of up to 6 target measurable nodes,extranodal sites;if lesion is too small to measure on computed tomography(CT),assign5mm×5mm as default;if no longer visible,0×0mm.Node\>5mm×5mm but smaller than normal,use actual measurement.2.Absent/regressed non-measured lesions,no increase.3.Organ enlargement-Spleen regressed by\>50%in length beyond normal.4.No new lesions.

  Up to approximately 148 weeks

Secondary Outcomes (6)

• Complete Response Rate With Parsaclisib Based on Lugano Classification Response Criteria

  Up to 1193 days

• Duration of Response (DOR)

  Up to 1193 days

• Progression-free Survival (PFS) With Parsaclisib

  Up to 1193 days

• Overall Survival (OS) With Parsaclisib

  Up to 1193 days

• Best Percent Change From Baseline in Target Lesion Size

  Up to 1193 days

Study Arms (2)

Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW

EXPERIMENTAL

Participants received parsaclisib 20 mg once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to approximately 52 weeks.

Drug: Parsaclisib

Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD

EXPERIMENTAL

Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks.

Drug: Parsaclisib

Interventions

Parsaclisib DRUG

Parsaclisib tablets administered orally with water and without regard to food

Also known as: INCB050465

Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW; Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (83)

Arizona Oncology Associates - Biltmore Cancer Center

Phoenix, Arizona, 85016, United States

Location

Beverly Hills Cancer Center

Beverly Hills, California, 90211, United States

Location

Synergy Hematology and Oncology Medical Associates

Los Angeles, California, 90036, United States

Location

St. Joseph Heritage Healthcare

Santa Rosa, California, 95403, United States

Location

American Institute of Research Corporate Office

Whittier, California, 90603, United States

Location

Cancer Center of Central Connecticut

Southington, Connecticut, 06489, United States

Location

Florida Cancer Specialists & Research Institute

Fort Myers, Florida, 33901, United States

Location

Asclepes Research Centers

Spring Hill, Florida, 34606, United States

Location

Clinical Trials of Swla Llc

Lake Charles, Louisiana, 70601, United States

Location

Saint Agnes Hospital

Baltimore, Maryland, 21229, United States

Location

Barbara Ann Karmanos Cancer Hospital

Detroit, Michigan, 48201, United States

Location

Hattiesburg Clinic Hematology

Hattiesburg, Mississippi, 39401, United States

Location

Saint Luke'S Hospital

Kansas City, Missouri, 64111, United States

Location

Sarah Cannon Research Institute

Kansas City, Missouri, 64132, United States

Location

Clinical Research Alliance, Inc.

New Hyde Park, New York, 11042, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Gabrail Cancer Center

Canton, Ohio, 44718, United States

Location

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

Charleston Hematology Oncology Associates Pa

Charleston, South Carolina, 29414, United States

Location

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

Renovatio Clinical Consultants Llc

Spring, Texas, 77380, United States

Location

University of Washington

Seattle, Washington, 98109, United States

Location

Western Health

St Albans, Victoria, 03021, Australia

Location

Border Medical Oncology

Wodonga, Victoria, 03690, Australia

Location

St Vincent'S Hospital Sydney

Darlinghurst, 02010, Australia

Location

Saint John Regional Hospital

Saint John, New Brunswick, E2L 4L2, Canada

Location

Sunnybrook Health Science Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Santa Cabrini Hospital

Montreal, Quebec, H1T 1P7, Canada

Location

University Hospital Hradec Kralove

Hradec Králové, 500 05, Czechia

Location

Fakultni Nemocnice Ostrava

Ostrava, 708 52, Czechia

Location

University Hospital Kralovkse Vinohrady

Prague, 10034, Czechia

Location

Univerzita Karlova V Praze 1. Lekarska Fakulta

Prague, 120 0, Czechia

Location

Fakultni Nemocnice V Motole

Prague, 15000, Czechia

Location

Aalborg University Hospital

Aalborg, 09000, Denmark

Location

Odense Universitetshospital (Ouh) (Odense University Hospital)

Odense C, 05000, Denmark

Location

Bag Arnoldstr. Dresden

Dresden, 01307, Germany

Location

University Medical Center Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

Mainz, 55131, Germany

Location

University Hospital Mannheim

Mannheim, 68167, Germany

Location

Semmelweis Egyetem

Budapest, 01085, Hungary

Location

National Institute of Oncology

Budapest, 01122, Hungary

Location

University of Debrecen

Debrecen, 04032, Hungary

Location

Somogy Medyei Kaposi Mor Oktato Korhaz

Kaposvár, 07400, Hungary

Location

Hillel Yafe Medical Center (Hymc)

Hadera, 38100, Israel

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Laniado Hospital Hematology

Netanya, 42150, Israel

Location

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Irccs Centro Di Riferimento Oncologico

Aviano, 33081, Italy

Location

Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari

Bari, 70124, Italy

Location

University of Bologna

Bologna, 40126, Italy

Location

Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori

Meldola, 47014, Italy

Location

Ospedale San Raffaele

Milan, 20132, Italy

Location

Fondazione Irccs Istituto Nazionale Dei Tumori

Milan, 20133, Italy

Location

A.O.U. Di Modena - Policlinico

Modena, 41124, Italy

Location

A.O.U. Federico Ii

Napoli, 80131, Italy

Location

Aou Maggiore Della Carita

Novara, 28100, Italy

Location

Ospedali Riuniti Villa Sofia Cervello

Palermo, 90146, Italy

Location

Sapienza University

Rome, 00161, Italy

Location

I.R.C.C.S. Casa Sollievo Della Sofferenza

San Giovanni Rotondo, 71013, Italy

Location

Aou Citta Della Salute E Della Scienza Di Torino

Torino, 10126, Italy

Location

San Bartolo Hospital

Vicenza, 36100, Italy

Location

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-952, Poland

Location

Pratia McM Krakow

Krakow, 30-510, Poland

Location

State Hospital Opole

Opole, 45-372, Poland

Location

Institute of Hematology and Transfusion Medicine

Warsaw, 02-776, Poland

Location

Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie

Warsaw, 02-781, Poland

Location

Hospital de La Santa Creu I Sant Pau

Barcelona, 08026, Spain

Location

Hospital General Universitari Vall D Hebron

Barcelona, 08035, Spain

Location

Hgu Gregorio Maranon

Madrid, 28009, Spain

Location

Md Anderson Cancer Centre Madrid

Madrid, 28033, Spain

Location

Hospital Universitario Ramon Y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario de La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Hm Sanchinarro

Madrid, 28050, Spain

Location

Hospital Universitario Quironsalud Madrid

Madrid, 28223, Spain

Location

Hospital Universitario de Canarias

San Cristóbal de La Laguna, 38320, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41007, Spain

Location

Hospital Universitario Virgen Del Rocio

Seville, 41013, Spain

Location

Karolinska University Hospital, Huddinge

Stockholm, 14141, Sweden

Location

Birmingham Heartlands Hospital

Birmingham, B9 5SS, United Kingdom

Location

Northwick Park Hospital

London, SE5 9RS, United Kingdom

Location

Royal Hallamshire Hospital

Sheffield, S10 2JF, United Kingdom

Location

The Royal Marsden Nhs Foundation Trust - Chelsea

Sutton, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, Follicular; Lymphoma, Non-Hodgkin; Hereditary Sensory and Autonomic Neuropathies

Interventions

parsaclisib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Study Officials

• Fred Zheng, MD, PhD

  Incyte Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2017
• First Posted: April 24, 2017
• Study Start: March 14, 2018
• Primary Completion: February 26, 2021
• Study Completion: June 7, 2024
• Last Updated: March 14, 2025
• Results First Posted: February 10, 2022

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement

Locations

IT (14); SE (1); DE (4); IL (5); ES (11); CZ (5); DK (2); AU (3); HU (4); PL (5); GB (4); CA (3); US (22)