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LymphomaPhase 2NCT03144674

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

A Phase 2 study testing Parsaclisib in people with Lymphoma, run by Incyte Corporation at 86 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
Parsaclisib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
86 sitesin 12 countries
Study dates
18 Dec 2017to 29 May 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

86 sites in 12 countries.

86 sites in 12 countries

United States33 sites

  • University of Michigan Cancer Center

    Ann Arbor, Michigan, 48109

  • University of Alabama At Birmingham Comprehensive Cancer Center

    Birmingham, Alabama, 35294

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Charleston Hematology Oncology Associates Pa

    Charleston, South Carolina, 29414

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University

    Chicago, Illinois, 60611

  • Rush University Medical Center - Consultants in Hematology

    Chicago, Illinois, 60612

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27705

  • Gettysburg Cancer Center

    Gettysburg, Pennsylvania, 17325

  • Valley View Hospital

    Glenwood Springs, Colorado, 81601

  • St. Mary'S Hospital Regional Cancer Center

    Grand Junction, Colorado, 81501

  • Saint Luke'S Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Clinical Trials of Swla Llc

    Lake Charles, Louisiana, 70601

  • COMPREHENSIVE CANCER CeNTERS OF NEVADA - TWAIN

    Las Vegas, Nevada, 89169

  • University of Miami Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • Advanced Pharma Cr

    Miami, Florida, 33147

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Clinical Research Alliance

    New Hyde Park, New York, 11042

  • Nyu Cancer Institute

    New York, New York, 10016

  • Hematology Oncology Associates of Rockland

    Nyack, New York, 10960

  • Boca Raton Clinical Research Medical Inc.

    Plantation, Florida, 33322

  • Torrance Health Association

    Redondo Beach, California, 90277

  • Sansum Clinic

    Santa Barbara, California, 93105

  • Central Coast Medical Oncology

    Santa Maria, California, 93454

  • UCLA Healthcare Hematology-Oncology

    Santa Monica, California, 90404

  • St. Joseph Heritage Healthcare

    Santa Rosa, California, 95403

  • University of Washington - Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Arizona Oncology Associates

    Tempe, Arizona, 85284

  • Renovatio Clinical

    The Woodlands, Texas, 77380

  • Asclepes Research Centers

    Weeki Wachee, Florida, 34607

  • White Plains Hospital

    White Plains, New York, 10601

  • Innovative Clinical Research Institute

    Whittier, California, 90603

  • Loyola University Medical Center

    Whittier, California, 90603

Other trials in United States

Italy9 sites

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

    Bologna, 40138

  • Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori

    Meldola, 47014

  • Fondazione Centro San Raffaele - Milano

    Milan, 20132

  • Fondazione Irccs Istituto Nazionale Dei Tumori

    Milan, 20133

  • Azienda Ospedaliera San Gerardo Di Monza

    Monza, 20900

  • Azienda Ospedaliera Ospedali Riuniti "Villa Sofia - Cervello"

    Palermo, 90146

  • Presidio Ospedaliero Pescara

    Pescara, 65124

  • Ospedale Delle Croci - Ematologia Ravenna

    Ravenna, 48121

  • Sapienza University

    Rome, 00161

Other trials in Italy

France8 sites

  • Avicenne Hospital

    Bobigny, 93000

  • Centre Hospitalier Universitaire Henri Mondor

    Créteil, 94010

  • Chu Limoges - Hospital Le Cluzeau

    Limoges, 87042

  • Hopital Saint-Louis

    Paris, 75010

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

    Paris, 75013

  • Hospices Civils de Lyon Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Centre Henri Becquerel

    Rouen, 76038

  • Institute Gustave Roussy (Igr)

    Villejuif, 94800

Other trials in France

Spain7 sites

  • Hospital General Universitari Vall D Hebron

    Barcelona, 08035

  • Ico Institut Catala D Oncologia

    Barcelona, 08908

  • Hgu Gregorio Maranon

    Madrid, 28007

  • Hospital Universitario Hm Sanchinarro

    Madrid, 28050

  • Hospital Universitario Quironsalud Madrid

    Madrid, 28223

  • Hospital Puerta de Hierro

    Majadahonda, 28222

  • Hospital Universitario de Salamanca

    Salamanca, 37007

Other trials in Spain

Germany6 sites

  • Universit�Tsklinikum Essen

    Essen, 45147

  • Universitatsmedizin Gottingen

    Göttingen, 37075

  • Universit�Tsklinikum Schleswig-Holstein

    Kiel, 24105

  • Klinikum Ludwigshafen

    Ludwigshafen, 67063

  • Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

    Mainz, 55131

  • Universit�Tsklinikum Ulm

    Ulm, 89081

Other trials in Germany

Israel5 sites

  • Rambam Medical Center

    Haifa, 31096

  • Hadassah Hebrew University Medical Center Ein Karem Hadassah

    Jerusalem, 91120

  • Rabin Medical Center - Beilinson Hospital

    Petah Tikva, 4841492

  • Chaim Sheba Medical Center

    Ramat Gan, 52621

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Poland5 sites

  • Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie

    Gdansk, 02-781

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

    Gdansk, 80-952

  • Malopolskie Centrum Medyczne S.C.

    Krakow, 30-510

  • Klinika Transplantacji Komorel Krwiotworczych

    Warsaw, 02-776

  • Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie

    Warsaw, 02-781

Other trials in Poland

United Kingdom4 sites

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS

  • Kent Oncology Centre - Maidstone Hospital

    Maidstone, ME16 9QQ

  • Norfolk and Norwich University Hospital

    Norwich, NR4 7UY

  • University of Southampton

    Southampton, SO16 6YD

Other trials in United Kingdom

Australia3 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 05000

  • Icon Cancer Care

    Auchenflower, Queensland, 04066

  • Calvary North Adelaide Hospital

    North Adelaide, South Australia, 05006

Other trials in Australia

Belgium3 sites

  • Cliniques Universitaires Ucl Saint-Luc

    Brussels, 01200

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • Universitaire Ziekenhuis Leuven - Gasthuisberg

    Leuven, 03000

Other trials in Belgium

Denmark2 sites

  • Aalborg University Hospital

    Aalborg, 09000

  • Zealand University Hospital

    Roskilde, 04000

Other trials in Denmark

Argentina1 site

  • Aou Maggiore Della Carita

    Rosario, S2000KZE

Other trials in Argentina

About this study

Official title: A Phase 2, Open-Label, 2-Cohort Study of INCB050465, a PI3Kδ Inhibitor, in Subjects With Relapsed or Refractory Marginal Zone Lymphoma With or Without Prior Exposure to a BTK Inhibitor (CITADEL-204)

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
Being tested
Parsaclisib
Keywords
Marginal zone lymphoma, phosphatidylinositol 3-kinase (PI3K)δ inhibitor, indolent (slow-growing) non-Hodgkin lymphoma B-cell lymphoma
Medical subject headings
Lymphoma, Lymphoma, B-Cell, Marginal Zone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ParsaclisibDrug

    Also called INCB050465

    Parsaclisib at the protocol-defined dose.

Study groups in NCT03144674
Study groupRoleWhat they receive
Cohort 1- Closed to Further enrollmentExperimentalParticipants who have received prior ibrutinib.
Receives: Drug: Parsaclisib
Cohort 2ExperimentalParticipants who have not received a prior BTK inhibitor.
Receives: Drug: Parsaclisib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to approximately 161 weeks

Secondary outcomes (6)

  1. Duration of Response (DOR)

    DOR=time from first documented evidence of CR or PR until disease progression or death from any cause among participants who achieve an objective response as determined by IRC. Criteria for CR: 1.Target nodes/nodal masses of lymph nodes and extralymphatic sites must regress to ≤ 1.5 cm in LDi; 2. Absence of non-measured lesion; 3.Organ enlargement regressed to normal; 4.No new lesions; 5.Bone marrow must be normal by morphology; if indeterminate, immunohistochemistry negative. The criteria for PR included: 1.Lymph nodes and extralymphatic sites- a. ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; b. when a lesion is too small to measure on CT, assign 5 mm×5 mm as the default; c.when no longer visible, 0×0 mm. For a node >5 mm×5 mm but smaller than normal, use actual measurement. 2.Non-measured lesions- Absent/regressed, but no increase. 3. Organ enlargement-Spleen must have regressed by >50% in length beyond normal. 4.No new lesions.

    Measured: Up to 1305 days

  2. Complete Response Rate (CRR) Based on Lugano Classification Criteria

    CRR is defined as the percentage of participants with a CR as determined by an IRC. The criteria for CR included: 1.Target nodes/nodal masses of lymph nodes and extralymphatic sites must regress to ≤ 1.5 cm in LDi; 2. Absence of non-measured lesion; 3.Organ enlargement regressed to normal; 4.No new lesions; 5.Bone marrow must be normal by morphology; if indeterminate, immunohistochemistry negative.

    Measured: Up to 1305 days

  3. Progression-Free Survival (PFS)

    PFS is defined as the time from the date of the first dose of study treatment until the earliest date of disease progression, as determined by radiographic disease assessment provided by an IRC, or death from any cause.

    Measured: Up to 1305 days

  4. Overall Survival (OS)

    OS is defined as the time from the date of the first dose of study treatment until death from any cause.

    Measured: Up to 2354 days

  5. Best Percent Change From Baseline in Target Lesion Size

    Target lesion size is measured by the sum of the product of diameters of all target lesion sizes and is determined by the IRC. The best percent change from Baseline is defined as the largest decrease, or smallest increase (if no decrease available), from Baseline in target lesion sizes on/before new (next-line) anti-lymphoma therapy during the study. Baseline is the last nonmissing measurement obtained before the first administration of study drug. A negative percent change from Baseline indicates improvement.

    Measured: Up to 1305 days

  6. Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    An adverse event (AE) is any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug regardless of starting new anti-lymphoma therapy. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect or is considered to be an important medical event that may not result in death, be immediately life-threatening, or require hospitalization but may be considered serious when, based on appropriate medical judgment, the event may jeopardize the participant or may require medical or surgical intervention.

    Measured: From first dose of study drug up to 1980 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2017
  2. Study start18 Dec 2017
  3. Primary completion15 Jan 2021
  4. Study completion29 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03144674
Sponsor's protocol ID
INCB 50465-204 (CITADEL-204)
Other IDs
Parsaclisib, 2017-000970-12, 2017
Status last verified
Jul 2025
First submitted
5 May 2017
Last updated
11 Jul 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Parsaclisib in people with Lymphoma, run by Incyte Corporation at 86 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in United States, Italy, France, Spain, Germany and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) Based on Lugano Classification Criteria (time frame: Up to approximately 161 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03144674.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.

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