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LymphomaPhase 2CITADEL-203NCT03126019

A Study of INCB050465 in Relapsed or Refractory Follicular Lymphoma

A Phase 2 study testing Parsaclisib in people with Lymphoma, run by Incyte Corporation at 83 sites in 13 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 assess the objective response rate of parsaclisib treatment in participants with relapsed or refractory follicular lymphoma. 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
83 sitesin 13 countries
Study dates
14 Mar 2018to 7 Jun 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

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

83 sites in 13 countries.

83 sites in 13 countries

United States22 sites

  • Saint Agnes Hospital

    Baltimore, Maryland, 21229

  • Beverly Hills Cancer Center

    Beverly Hills, California, 90211

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Charleston Hematology Oncology Associates Pa

    Charleston, South Carolina, 29414

  • Barbara Ann Karmanos Cancer Hospital

    Detroit, Michigan, 48201

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Florida Cancer Specialists & Research Institute

    Fort Myers, Florida, 33901

  • Hattiesburg Clinic Hematology

    Hattiesburg, Mississippi, 39401

  • Saint Luke'S Hospital

    Kansas City, Missouri, 64111

  • Sarah Cannon Research Institute

    Kansas City, Missouri, 64132

  • Clinical Trials of Swla Llc

    Lake Charles, Louisiana, 70601

  • Synergy Hematology and Oncology Medical Associates

    Los Angeles, California, 90036

  • Tennessee Oncology

    Nashville, Tennessee, 37203

  • Clinical Research Alliance, Inc.

    New Hyde Park, New York, 11042

  • University of Pennsylvania Health System

    Philadelphia, Pennsylvania, 19104

  • Arizona Oncology Associates - Biltmore Cancer Center

    Phoenix, Arizona, 85016

  • St. Joseph Heritage Healthcare

    Santa Rosa, California, 95403

  • University of Washington

    Seattle, Washington, 98109

  • Cancer Center of Central Connecticut

    Southington, Connecticut, 06489

  • Renovatio Clinical Consultants Llc

    Spring, Texas, 77380

  • Asclepes Research Centers

    Spring Hill, Florida, 34606

  • American Institute of Research Corporate Office

    Whittier, California, 90603

Other trials in United States

Italy14 sites

  • Irccs Centro Di Riferimento Oncologico

    Aviano, 33081

  • Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari

    Bari, 70124

  • University of Bologna

    Bologna, 40126

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

    Meldola, 47014

  • Ospedale San Raffaele

    Milan, 20132

  • Fondazione Irccs Istituto Nazionale Dei Tumori

    Milan, 20133

  • A.O.U. Di Modena - Policlinico

    Modena, 41124

  • A.O.U. Federico Ii

    Naples, 80131

  • Aou Maggiore Della Carita

    Novara, 28100

  • Ospedali Riuniti Villa Sofia Cervello

    Palermo, 90146

  • Sapienza University

    Rome, 00161

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

    San Giovanni Rotondo, 71013

  • Aou Citta Della Salute E Della Scienza Di Torino

    Torino, 10126

  • San Bartolo Hospital

    Vicenza, 36100

Other trials in Italy

Spain11 sites

  • Hospital de La Santa Creu I Sant Pau

    Barcelona, 08026

  • Hospital General Universitari Vall D Hebron

    Barcelona, 08035

  • Hgu Gregorio Maranon

    Madrid, 28009

  • Md Anderson Cancer Centre Madrid

    Madrid, 28033

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034

  • Hospital Universitario de La Paz

    Madrid, 28046

  • Hospital Universitario Hm Sanchinarro

    Madrid, 28050

  • Hospital Universitario Quironsalud Madrid

    Madrid, 28223

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, 38320

  • Hospital Universitario Virgen Macarena

    Seville, 41007

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013

Other trials in Spain

Czechia5 sites

  • University Hospital Hradec Kralove

    Hradec Králové, 500 05

  • Fakultni Nemocnice Ostrava

    Ostrava, 708 52

  • University Hospital Kralovkse Vinohrady

    Prague, 10034

  • Univerzita Karlova V Praze 1. Lekarska Fakulta

    Prague, 120 0

  • Fakultni Nemocnice V Motole

    Prague, 15000

Other trials in Czechia

Israel5 sites

  • Hillel Yafe Medical Center (Hymc)

    Hadera, 38100

  • Rambam Medical Center

    Haifa, 31096

  • Laniado Hospital Hematology

    Netanya, 42150

  • Sheba Medical Center

    Ramat Gan, 52621

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Poland5 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952

  • Pratia McM Krakow

    Krakow, 30-510

  • State Hospital Opole

    Opole, 45-372

  • Institute of Hematology and Transfusion Medicine

    Warsaw, 02-776

  • Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie

    Warsaw, 02-781

Other trials in Poland

Germany4 sites

  • Bag Arnoldstr. Dresden

    Dresden, 01307

  • University Medical Center Freiburg

    Freiburg im Breisgau, 79106

  • Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

    Mainz, 55131

  • University Hospital Mannheim

    Mannheim, 68167

Other trials in Germany

Hungary4 sites

  • Semmelweis Egyetem

    Budapest, 01085

  • National Institute of Oncology

    Budapest, 01122

  • University of Debrecen

    Debrecen, 04032

  • Somogy Medyei Kaposi Mor Oktato Korhaz

    Kaposvár, 07400

Other trials in Hungary

United Kingdom4 sites

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS

  • Northwick Park Hospital

    London, SE5 9RS

  • Royal Hallamshire Hospital

    Sheffield, S10 2JF

  • The Royal Marsden Nhs Foundation Trust - Chelsea

    Sutton, SM2 5PT

Other trials in United Kingdom

Australia3 sites

  • St Vincent'S Hospital Sydney

    Darlinghurst, 02010

  • Western Health

    St Albans, Victoria, 03021

  • Border Medical Oncology

    Wodonga, Victoria, 03690

Other trials in Australia

Canada3 sites

  • Santa Cabrini Hospital

    Montreal, Quebec, H1T 1P7

  • Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • Sunnybrook Health Science Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

Denmark2 sites

  • Aalborg University Hospital

    Aalborg, 09000

  • Odense Universitetshospital (Ouh) (Odense University Hospital)

    Odense C, 05000

Other trials in Denmark

Sweden1 site

  • Karolinska University Hospital, Huddinge

    Stockholm, 14141

Other trials in Sweden

About this study

Official title: A Phase 2, Multicenter, Open-Label Study of INCB050465, a PI3Kδ Inhibitor in Relapsed or Refractory Follicular Lymphoma (CITADEL-203)

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
Being tested
Parsaclisib
Keywords
Follicular lymphoma, non-Hodgkin lymphoma (NHL), phosphatidylinositol 3-kinase (PI3K) δ inhibitor
Medical subject headings
Lymphoma, Lymphoma, Follicular, Lymphoma, Non-Hodgkin, Hereditary Sensory and Autonomic Neuropathies

What participants receive

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

  • ParsaclisibDrug

    Also called INCB050465

    Parsaclisib tablets administered orally with water and without regard to food

Study groups in NCT03126019
Study groupRoleWhat they receive
Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QWExperimentalParticipants received parsaclisib 20 mg once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to approximately 52 weeks.
Receives: Drug: Parsaclisib
Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QDExperimentalParticipants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks.
Receives: Drug: Parsaclisib

What is being measured

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

  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.

    Measured: Up to approximately 148 weeks

Secondary outcomes (6)

  1. Complete Response Rate With Parsaclisib Based on Lugano Classification Response Criteria

    CRR was defined as the percentage of participants with a CR as defined by revised response criteria for lymphomas 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 1193 days

  2. 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 1193 days

  3. Progression-free Survival (PFS) With Parsaclisib

    PFS was 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 1193 days

  4. Overall Survival (OS) With Parsaclisib

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

    Measured: Up to 1193 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 non-missing measurement obtained before the first administration of study drug. A negative percent change from Baseline indicates improvement.

    Measured: Up to 1193 days

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

    An adverse event (AE) is defined as 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. TEAE is any AE either reported for first time or worsening of a pre-existing event after first dose of study drug and within 30 days of last administration of study drug regardless of starting new anti-lymphoma therapy. 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: up to approximately 1992 days

Timeline

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

  1. First posted24 Apr 2017
  2. Study start14 Mar 2018
  3. Primary completion26 Feb 2021
  4. Study completion7 Jun 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
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03126019
Sponsor's protocol ID
INCB 50465-203 (CITADEL-203)
Other IDs
Parsaclisib, 2017-001624-22, 2017
Acronym
CITADEL-203
Status last verified
Mar 2025
First submitted
20 Apr 2017
Last updated
14 Mar 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

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 83 sites in 13 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 7 inclusion and 7 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 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites in United States, Italy, Spain, Czechia, Israel and 8 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 With Parsaclisib Based on Lugano Classification Response Criteria (time frame: Up to approximately 148 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 NCT03126019.

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 14 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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