A Study of INCB050465 in Subjects With Relapsed or Refractory Marginal Zone Lymphoma (CITADEL-204)

NCT03144674 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: INCB 50465-204 (CITADEL-204)Parsaclisib2017-000970-12
• Study Type: interventional
• Target: 110
• Locations: 12 countries
• Sites: 86

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of two parsaclisib treatment regimens in participants diagnosed with relapsed or refractory marginal zone lymphoma (MZL) who are naive to or were previously treated with a Bruton's tyrosine kinase (BTK) inhibitor.

Conditions

Lymphoma

Keywords

Marginal zone lymphoma; phosphatidylinositol 3-kinase (PI3K)δ inhibitor; indolent (slow-growing) non-Hodgkin lymphoma B-cell lymphoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) Based on Lugano Classification 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),assign 5mm×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 161 weeks

Secondary Outcomes (6)

• Duration of Response (DOR)

  Up to 1305 days

• Complete Response Rate (CRR) Based on Lugano Classification Criteria

  Up to 1305 days

• Progression-Free Survival (PFS)

  Up to 1305 days

• Overall Survival (OS)

  Up to 2354 days

• Best Percent Change From Baseline in Target Lesion Size

  Up to 1305 days

Study Arms (2)

Cohort 1- Closed to Further enrollment

EXPERIMENTAL

Participants who have received prior ibrutinib.

Drug: Parsaclisib

Cohort 2

EXPERIMENTAL

Participants who have not received a prior BTK inhibitor.

Drug: Parsaclisib

Interventions

Parsaclisib DRUG

Parsaclisib at the protocol-defined dose.

Also known as: INCB050465

Cohort 1- Closed to Further enrollment; Cohort 2

Eligibility Criteria

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

You may qualify if:

• Men and women, aged 18 or older (except in South Korea, aged 19 or older).
• Histologically confirmed marginal zone lymphoma, including extranodal, nodal, and splenic subtypes.
• Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures \> 1.5 cm in the longest transverse diameter and ≥ 1.0 cm in the longest perpendicular diameter.
• Participants with splenic MZL who do not meet the radiographically measurable disease criteria described herein are eligible for participation provided that bone marrow infiltration of MZL is histologically confirmed.
• Participants must be willing to undergo an incisional or excisional lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue.
• Eastern Cooperative Oncology Group performance status 0 to 2.

You may not qualify if:

• Evidence of diffuse large B-cell transformation.
• History of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease.
• Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan-PI3K inhibitor.
• Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of the first dose of study treatment.
• Active graft versus host disease.
• Subjects positive for hepatitis B surface antigen or hepatitis B core antibody will be eligible if they are negative for HBV-DNA. Subjects positive for anti-HCV antibody will be eligible if they are negative for HCV-RNA.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (86)

University of Alabama At Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

Arizona Oncology Associates

Tempe, Arizona, 85284, United States

Location

Torrance Health Association

Redondo Beach, California, 90277, United States

Location

Sansum Clinic

Santa Barbara, California, 93105, United States

Location

Central Coast Medical Oncology

Santa Maria, California, 93454, United States

Location

UCLA Healthcare Hematology-Oncology

Santa Monica, California, 90404, United States

Location

St. Joseph Heritage Healthcare

Santa Rosa, California, 95403, United States

Location

Innovative Clinical Research Institute

Whittier, California, 90603, United States

Location

Loyola University Medical Center

Whittier, California, 90603, United States

Location

Valley View Hospital

Glenwood Springs, Colorado, 81601, United States

Location

St. Mary'S Hospital Regional Cancer Center

Grand Junction, Colorado, 81501, United States

Location

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

Advanced Pharma Cr

Miami, Florida, 33147, United States

Location

Boca Raton Clinical Research Medical Inc.

Plantation, Florida, 33322, United States

Location

Asclepes Research Centers

Weeki Wachee, Florida, 34607, United States

Location

Robert H. Lurie Comprehensive Cancer Center of Northwestern University

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center - Consultants in Hematology

Chicago, Illinois, 60612, United States

Location

Clinical Trials of Swla Llc

Lake Charles, Louisiana, 70601, United States

Location

University of Michigan Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Saint Luke'S Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

COMPREHENSIVE CANCER CeNTERS OF NEVADA - TWAIN

Las Vegas, Nevada, 89169, United States

Location

Clinical Research Alliance

New Hyde Park, New York, 11042, United States

Location

Nyu Cancer Institute

New York, New York, 10016, United States

Location

Hematology Oncology Associates of Rockland

Nyack, New York, 10960, United States

Location

White Plains Hospital

White Plains, New York, 10601, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Gabrail Cancer Center

Canton, Ohio, 44718, United States

Location

Gettysburg Cancer Center

Gettysburg, Pennsylvania, 17325, United States

Location

Charleston Hematology Oncology Associates Pa

Charleston, South Carolina, 29414, United States

Location

Renovatio Clinical

The Woodlands, Texas, 77380, United States

Location

University of Washington - Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Aou Maggiore Della Carita

Rosario, S2000KZE, Argentina

Location

Icon Cancer Care

Auchenflower, Queensland, 04066, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 05000, Australia

Location

Calvary North Adelaide Hospital

North Adelaide, South Australia, 05006, Australia

Location

Cliniques Universitaires Ucl Saint-Luc

Brussels, 01200, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Universitaire Ziekenhuis Leuven - Gasthuisberg

Leuven, 03000, Belgium

Location

Aalborg University Hospital

Aalborg, 09000, Denmark

Location

Zealand University Hospital

Roskilde, 04000, Denmark

Location

Avicenne Hospital

Bobigny, 93000, France

Location

Centre Hospitalier Universitaire Henri Mondor

Créteil, 94010, France

Location

Chu Limoges - Hospital Le Cluzeau

Limoges, 87042, France

Location

Hopital Saint-Louis

Paris, 75010, France

Location

H�Pital Universitaire Piti�-Salp�Tri�Re

Paris, 75013, France

Location

Hospices Civils de Lyon Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Institute Gustave Roussy (Igr)

Villejuif, 94800, France

Location

Universit�Tsklinikum Essen

Essen, 45147, Germany

Location

Universitatsmedizin Gottingen

Göttingen, 37075, Germany

Location

Universit�Tsklinikum Schleswig-Holstein

Kiel, 24105, Germany

Location

Klinikum Ludwigshafen

Ludwigshafen, 67063, Germany

Location

Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

Mainz, 55131, Germany

Location

Universit�Tsklinikum Ulm

Ulm, 89081, Germany

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Hadassah Hebrew University Medical Center Ein Karem Hadassah

Jerusalem, 91120, Israel

Location

Rabin Medical Center - Beilinson Hospital

Petah Tikva, 4841492, Israel

Location

Chaim Sheba Medical Center

Ramat Gan, 52621, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

University of Bologna, Institute of Haematology �L. E A. Ser�Gnoli�

Bologna, 40138, Italy

Location

Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori

Meldola, 47014, Italy

Location

Fondazione Centro San Raffaele - Milano

Milan, 20132, Italy

Location

Fondazione Irccs Istituto Nazionale Dei Tumori

Milan, 20133, Italy

Location

Azienda Ospedaliera San Gerardo Di Monza

Monza, 20900, Italy

Location

Azienda Ospedaliera Ospedali Riuniti "Villa Sofia - Cervello"

Palermo, 90146, Italy

Location

Presidio Ospedaliero Pescara

Pescara, 65124, Italy

Location

Ospedale Delle Croci - Ematologia Ravenna

Ravenna, 48121, Italy

Location

Sapienza University

Rome, 00161, Italy

Location

Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie

Gdansk, 02-781, Poland

Location

Szpitale Wojew�Dzkie W Gdyni Sp�?Ka Z Ograniczon? Odpowiedzialno?Ci?

Gdansk, 80-952, Poland

Location

Malopolskie Centrum Medyczne S.C.

Krakow, 30-510, Poland

Location

Klinika Transplantacji Komorel Krwiotworczych

Warsaw, 02-776, Poland

Location

Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie

Warsaw, 02-781, Poland

Location

Hospital General Universitari Vall D Hebron

Barcelona, 08035, Spain

Location

Ico Institut Catala D Oncologia

Barcelona, 08908, Spain

Location

Hgu Gregorio Maranon

Madrid, 28007, Spain

Location

Hospital Universitario Hm Sanchinarro

Madrid, 28050, Spain

Location

Hospital Universitario Quironsalud Madrid

Madrid, 28223, Spain

Location

Hospital Puerta de Hierro

Majadahonda, 28222, Spain

Location

Hospital Universitario de Salamanca

Salamanca, 37007, Spain

Location

Birmingham Heartlands Hospital

Birmingham, B9 5SS, United Kingdom

Location

Kent Oncology Centre - Maidstone Hospital

Maidstone, ME16 9QQ, United Kingdom

Location

Norfolk and Norwich University Hospital

Norwich, NR4 7UY, United Kingdom

Location

University of Southampton

Southampton, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, B-Cell, Marginal Zone

Interventions

parsaclisib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Study Officials

• Fred Zheng, MD

  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: May 5, 2017
• First Posted: May 9, 2017
• Study Start: December 18, 2017
• Primary Completion: January 15, 2021
• Study Completion: May 29, 2024
• Last Updated: July 11, 2025
• Results First Posted: February 10, 2022

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (8); AR (1); US (33); IL (5); IT (9); DK (2); PL (5); ES (7); AU (3); GB (4); DE (6); BE (3)