A Study of INCB050465 in Relapsed or Refractory Follicular Lymphoma

Lymphoma Clinical Trial

— CITADEL-203  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03126019
• Other study ID #: INCB 50465-203 (CITADEL-203)
• Secondary ID: Parsaclisib2017-
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 14, 2018
• Est. completion date: July 31, 2024

Study information

• Verified date: January 2024
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 126
• Est. completion date: July 31, 2024
• Est. primary completion date: February 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 (PI3Kd) 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).

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Follicular

Intervention

Drug:
• Parsaclisib
Parsaclisib tablets administered orally with water and without regard to food

Locations

Country	Name	City	State
Australia	St Vincent'S Hospital Sydney	Darlinghurst
Australia	Western Health	St Albans	Victoria
Australia	Border Medical Oncology	Wodonga	Victoria
Canada	Santa Cabrini Hospital	Montreal	Quebec
Canada	Saint John Regional Hospital	St. John	New Brunswick
Canada	Sunnybrook Health Science Centre	Toronto	Ontario
Czechia	University Hospital Hradec Kralove	Hradec Kralove
Czechia	Fakultni Nemocnice Ostrava	Ostrava
Czechia	University Hospital Kralovkse Vinohrady	Prague
Czechia	Univerzita Karlova V Praze 1. Lekarska Fakulta	Praha
Czechia	Fakultni Nemocnice V Motole	Praha 5
Denmark	Aalborg University Hospital	Aalborg
Denmark	Odense Universitetshospital (Ouh) (Odense University Hospital)	Odense C
Germany	Bag Arnoldstr. Dresden	Dresden
Germany	University Medical Center Freiburg	Freiburg
Germany	Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii	Mainz
Germany	University Hospital Mannheim	Mannheim
Hungary	National Institute of Oncology	Budapest
Hungary	Semmelweis Egyetem	Budapest
Hungary	University of Debrecen	Debrecen
Hungary	Somogy Medyei Kaposi Mor Oktato Korhaz	Kaposvar
Israel	Hillel Yafe Medical Center (Hymc)	Hadera
Israel	Rambam Medical Center	Haifa
Israel	Laniado Hospital Hematology	Netanya
Israel	Sheba Medical Center	Ramat Gan
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv-yafo
Italy	Irccs Centro Di Riferimento Oncologico	Aviano
Italy	Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari	Bari
Italy	University of Bologna	Bologna
Italy	Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori	Meldola
Italy	Fondazione Irccs Istituto Nazionale Dei Tumori	Milano
Italy	Ospedale San Raffaele	Milano
Italy	A.O.U. Di Modena - Policlinico	Modena
Italy	A.O.U. Federico Ii	Napoli
Italy	Aou Maggiore Della Carita	Novara
Italy	Ospedali Riuniti Villa Sofia Cervello	Palermo
Italy	Sapienza University	Rome
Italy	I.R.C.C.S. Casa Sollievo Della Sofferenza	San Giovanni Rotondo
Italy	Aou Citta Della Salute E Della Scienza Di Torino	Torino
Italy	San Bartolo Hospital	Vicenza
Poland	Uniwersyteckie Centrum Kliniczne	Gdansk
Poland	Pratia McM Krakow	Krakow
Poland	State Hospital Opole	Opole
Poland	Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie	Warszawa
Poland	Institute of Hematology and Transfusion Medicine	Warszawa
Spain	Hospital de La Santa Creu I Sant Pau	Barcelona
Spain	Hospital General Universitari Vall D Hebron	Barcelona
Spain	Hgu Gregorio Maranon	Madrid
Spain	Hospital Universitario de La Paz	Madrid
Spain	Hospital Universitario Hm Sanchinarro	Madrid
Spain	Hospital Universitario Quironsalud Madrid	Madrid
Spain	Hospital Universitario Ramon Y Cajal	Madrid
Spain	Md Anderson Cancer Centre Madrid	Madrid
Spain	Hospital Universitario de Canarias	San Cristobal de La Laguna
Spain	Hospital Universitario Virgen Del Rocio	Sevilla
Spain	Hospital Universitario Virgen Macarena	Sevilla
Sweden	Karolinska University Hospital, Huddinge	Stockholm
United Kingdom	Birmingham Heartlands Hospital	Birmingham
United Kingdom	Northwick Park Hospital	London
United Kingdom	Royal Hallamshire Hospital	Sheffield
United Kingdom	The Royal Marsden Nhs Foundation Trust - Chelsea	Sutton
United States	Saint Agnes Hospital	Baltimore	Maryland
United States	Beverly Hills Cancer Center	Beverly Hills	California
United States	Gabrail Cancer Center	Canton	Ohio
United States	Charleston Hematology Oncology Associates Pa	Charleston	South Carolina
United States	Barbara Ann Karmanos Cancer Hospital	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	Florida Cancer Specialists & Research Institute	Fort Myers	Florida
United States	Hattiesburg Clinic Hematology	Hattiesburg	Mississippi
United States	Saint Luke'S Hospital	Kansas City	Missouri
United States	Sarah Cannon Research Institute	Kansas City	Missouri
United States	Clinical Trials of Swla Llc	Lake Charles	Louisiana
United States	Synergy Hematology and Oncology Medical Associates	Los Angeles	California
United States	Tennessee Oncology	Nashville	Tennessee
United States	Clinical Research Alliance, Inc.	New Hyde Park	New York
United States	University of Pennsylvania Health System	Philadelphia	Pennsylvania
United States	Arizona Oncology Associates - Biltmore Cancer Center	Phoenix	Arizona
United States	St. Joseph Heritage Healthcare	Santa Rosa	California
United States	University of Washington	Seattle	Washington
United States	Cancer Center of Central Connecticut	Southington	Connecticut
United States	Renovatio Clinical Consultants Llc	Spring	Texas
United States	Asclepes Research Centers	Spring Hill	Florida
United States	American Institute of Research Corporate Office	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Czechia,  Denmark,  Germany,  Hungary,  Israel,  Italy,  Poland,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Up to approximately 148 weeks
Secondary	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.	Up to approximately 148 weeks
Secondary	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.	Up to approximately 148 weeks
Secondary	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.	Up to approximately 148 weeks
Secondary	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.	Up to approximately 148 weeks
Secondary	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.	From first dose of study drug up to approximately 148 weeks