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LymphomaPhase 2(CITADEL-205)NCT03235544

A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a Bruton's Tyrosine Kinase (BTK) Inhibitor

A Phase 2 study testing Parsaclisib in people with Lymphoma, run by Incyte Corporation at 103 sites in 11 countries.

Completed

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

Official record
Search all trials

Trial summary

This is a Phase 2, open-label, 2-cohort study designed to evaluate the efficacy and safety of 2 parsaclisib treatment regimens in participants with relapsed or refractory mantle cell lymphoma (MCL) previously treated either with or without 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
162 participants
Where
103 sitesin 11 countries
Study dates
20 Nov 2017to 30 Apr 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 years or older.
  • Documented failure to achieve at least partial response (PR) with, or documented disease progression after, the most recent treatment regimen.
  • Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.

Who cannot join

  • 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.
  • Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of first dose of study treatment.
  • Active graft-versus-host disease.
  • Liver 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

103 sites in 11 countries.

103 sites in 11 countries

United States21 sites

  • Rocky Mountain Cancer Center-Aurora

    Aurora, Colorado, 80012

  • Texas Oncology

    Austin, Texas, 78705

  • University of Alabama At Birmingham Comprehensive Cancer Center

    Birmingham, Alabama, 35205

  • Asclepes Research Centers

    Brooksville, Florida, 34613

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio, 45230

  • Duke University Medical Center

    Durham, North Carolina, 27705

  • Willamette Valley Cancer Institute

    Eugene, Oregon, 97401

  • Gettysburg Cancer Center

    Gettysburg, Pennsylvania, 17325

  • Hattiesburg Clinic Hematology

    Hattiesburg, Mississippi, 39401

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Clinical Research Alliance, Inc.

    New Hyde Park, New York, 11042

  • Illinois Cancer Specialists

    Niles, Illinois, 60714

  • Kaiser Permanente - Northwest

    Portland, Oregon, 97227

  • Texas Oncology San Antonio

    San Antonio, Texas, 78240

  • St. Joseph Heritage Healthcare

    Santa Rosa, California, 95403

  • Moffitt Cancer Center

    Tampa, Florida, 33647

  • Renovatio Clinical

    The Woodlands, Texas, 77380

  • Texas Oncology - Tyler

    Tyler, Texas, 75702

  • Bond & Steele Clinic, P.A.

    Winter Haven, Florida, 33880

  • Yakima Valley Memorial Hospital/North Star

    Yakima, Washington, 98902

Other trials in United States

Spain18 sites

  • Hospital Del Mar

    Barcelona, 08003

  • Hospital General Universitari Vall D Hebron

    Barcelona, 08035

  • Hospital Universitari Mutua Terrassa

    Barcelona, 08221

  • Institut Catala D Oncologia

    Barcelona, 08916

  • Hospital Universitario de Burgos

    Burgos, 09006

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • Md Anderson Cancer Centre Madrid

    Madrid, 28033

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034

  • Fundacion Jimenez Diaz University Hospital

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario de La Paz

    Madrid, 28046

  • Hospital General Universitario Morales Meseguer

    Murcia, 30008

  • Complejo Hospitalario de Navarra

    Pamplona, 31008

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario Virgen del Rocio

    Seville, 41005

  • Hospital Arnau de Vilanova

    Valencia, 46015

  • Hospital Universitario Dr. Peset

    Valencia, 46017

  • Hospital Universitario Y Politecnic La Fe

    Valencia, 46026

Other trials in Spain

France16 sites

  • Avicenne Hospital

    Bobigny, 93000

  • Chu de Clermont - Ferrand- Hospital Estaing

    Clermont-Ferrand, 63230

  • Centre Hospitalier Universitaire Henri Mondor

    Créteil, 94010

  • University Hospital Grenoble

    Grenoble, 38043

  • Centre Hospitalier Departemental - La-Roche-Sur-Yon - Les Oudairies

    La Roche-sur-Yon, 85925

  • Centre Hospitalier Universitaire de Grenoble

    La Tronche, 38700

  • Centre Hospitalier de Versailles

    Le Chesnay, 78157

  • Hospices Civils de Lyon Centre Hospitalier Lyon Sud

    Lyon, 69008

  • Centre Antoine Lacassagne

    Nice, 06189

  • Hopital Saint-Louis

    Paris, 75010

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

    Paris, 75013

  • Centre Hospitalier Lyon-Sud

    Pierre-Bénite, 69310

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, 86021

  • Centre Henri Becquerel

    Rouen, 76038

  • Chru Hopitaux de Tours, Hospital Bretonneau

    Tours, 37044

  • Institute Gustave Roussy (Igr)

    Villejuif, 94805

Other trials in France

Italy12 sites

  • Centro Ricerche Cliniche

    Bologna, 40138

  • Azienda Policlinico Vittorio Emanuele

    Catania, 95123

  • Fondazione Irccs Istituto Nazionale Dei Tumori

    Milan, MI, 20133

  • Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • Ospedale Niguarda Ca Granda

    Milan, 22162

  • 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

  • Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte

    Siena, 53100

  • Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza

    Torino, 10126

Other trials in Italy

Germany8 sites

  • Praxis Brudler, Heinrich, Bangerter

    Augsburg, 86150

  • Universitaetsklinikum Essen

    Essen, 45122

  • Universit�Tsklinikum Essen

    Essen, 45147

  • Justus-Liebig University

    Giessen, 35392

  • Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

    Mainz, 55131

  • Kliniken Maria Hilf

    Mönchengladbach, 41063

  • Rotkreuzklinikum Munich

    München, 80634

  • Universit�Tsklinikum Ulm

    Ulm, 89081

Other trials in Germany

Poland6 sites

  • Beskidzkie Centrum Onkologii Im.Jana Pawla Ii

    Bielsko-Biala, 43-300

  • Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza

    Brzozów, 36-200

  • University Clinical Center

    Gdansk, 80-952

  • Pratia McM Krakow

    Krakow, 30-510

  • Nu-Med Centrum Diagnostykii I Terapii Onkologicznej

    Tomaszów Mazowiecki, 97-200

  • Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie

    Warsaw, 02-781

Other trials in Poland

Israel5 sites

  • Rambam Medical Center

    Haifa, 31096

  • Hadassah Hebrew University Medical Center

    Jerusalem, 90000

  • Hadassah Hebrew University Medical Center Ein Karem Hadassah

    Jerusalem, 91120

  • Rabin Medical Center - Beilinson Hospital

    Petah Tikva, 4841492

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

United Kingdom5 sites

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS

  • Western General Hospital

    Edinburgh, EH4 2XU

  • University College London Hospitals (Uclh)

    London, NW1 2PG

  • Derriford Hospital

    Plymouth, PL6 8DH

  • Royal Hallamshire Hospital

    Sheffield, S10 2JF

Other trials in United Kingdom

Belgium4 sites

  • Institut Jules Bordet

    Brussels

  • Universitair Ziekenhuis Gent

    Ghent, Oost-Vlaanderen, 9000

  • Hopital de Jolimont

    La Louvière, 07100

  • Universitaire Ziekenhuis Leuven - Gasthuisberg

    Leuven, 03000

Other trials in Belgium

Czechia4 sites

  • Fakultni Nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Fakultni Nemocnice Kralovske Vinohadry, Interni Hematologicka Klinika

    Prague, 10034

  • Charles University General Hospital

    Prague, 128 08

  • Fakultni Nemocnice Kralovske Vinohrady

    Prague, 500 05

Other trials in Czechia

Denmark4 sites

  • Aalborg University Hospital

    Aalborg, 09000

  • Aarhus Universitets Hospital

    Aarhus, DK-8000

  • Odense Universitetshospital (Ouh) (Odense University Hospital)

    Odense C, 05000

  • Zealand University Hospital

    Roskilde, 04000

Other trials in Denmark

About this study

Official title: A Phase 2, Open-Label, 2-Cohort, Multicenter Study of INCB050465, a PI3Kδ Inhibitor, in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a BTK Inhibitor (CITADEL-205)

This is a Phase 2, open-label, 2-cohort study designed to evaluate the efficacy and safety of 2 parsaclisib treatment regimens in participants with relapsed or refractory mantle cell lymphoma (MCL) previously treated either with or without a Bruton's tyrosine kinase (BTK) inhibitor.

Conditions
Lymphoma
Being tested
Parsaclisib
Keywords
Mantle cell lymphoma, non-Hodgkin lymphoma, Bruton's tyrosine kinase (BTK), phosphatidylinositol 3-kinase (PI3K)
Medical subject headings
Lymphoma, Lymphoma, Mantle-Cell, Lymphoma, Non-Hodgkin

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 NCT03235544
Study groupRoleWhat they receive
Cohort 1: Treatment A (Exposed to Ibrutinib)ExperimentalParticipants received parsaclisib 20 mg tablets, orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
Receives: Drug: Parsaclisib
Cohort 1: Treatment B (Exposed to Ibrutinib)ExperimentalParticipants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
Receives: Drug: Parsaclisib
Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve)ExperimentalParticipants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who had not received a BTK inhibitor previously were included in this group.
Receives: Drug: Parsaclisib
Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve)ExperimentalParticipants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who had not received a BTK inhibitor previously were included in this group.
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)

    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 1016 days

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 1016 days

  2. Complete Response Rate (CRR)

    CRR is defined as the percentage of participants with a CR as defined by 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 1016 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 1016 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 2017 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 1016 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 2045 days

Timeline

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

  1. First posted1 Aug 2017
  2. Study start20 Nov 2017
  3. Primary completion30 Apr 2024
  4. Study completion30 Apr 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
162 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03235544
Sponsor's protocol ID
INCB 50465-205 (CITADEL-205)
Other IDs
Parsaclisib, 2017-003148-19, 2017
Acronym
(CITADEL-205)
Status last verified
Feb 2025
First submitted
27 Jul 2017
Last updated
18 Mar 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data (IPD) will be made available to interested researchers after the end of study, a thorough analysis, and the publication of the data in the clinical study report (CSR). As required, results of the data will be posted to ClinicalTrials.gov. Upon request, individual investigators may obtain IPD from the sponsor. The format for data delivery will be determined between sponsor and investigator.

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 103 sites in 11 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 4 inclusion and 5 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 18 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 103 sites in United States, Spain, France, Italy, Germany and 6 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) (time frame: Up to 1016 days). 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 NCT03235544.

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 18 Mar 2025.

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