Clinical trial NCT03144674: A Study of INCB050465 in Subjects With Relapsed or Refractory Marginal Zone Lymphoma (CITADEL-204)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Keywords: Marginal zone lymphoma
phosphatidylinositol 3-kinase (PI3K)δ inhibitor
indolent (slow-growing) non-Hodgkin lymphoma B-cell lymphoma
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2017-05-09
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Objective Response Rate (ORR) Based on Lugano Classification Criteria
timeFrame: Up to approximately 161 weeks
Secondary outcomes:
measure: Duration of Response (DOR)
timeFrame: Up to 1305 days
measure: Complete Response Rate (CRR) Based on Lugano Classification Criteria
timeFrame: Up to 1305 days
measure: Progression-Free Survival (PFS)
timeFrame: Up to 1305 days
measure: Overall Survival (OS)
timeFrame: Up to 2354 days
measure: Best Percent Change From Baseline in Target Lesion Size
timeFrame: Up to 1305 days
measure: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: From first dose of study drug up to 1980 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama At Birmingham Comprehensive Cancer Center
state: Alabama
city: Tempe
country: United States
facility: Arizona Oncology Associates
state: Arizona
city: Redondo Beach
country: United States
facility: Torrance Health Association
state: California
city: Santa Barbara
country: United States
facility: Sansum Clinic
state: California
city: Santa Maria
country: United States
facility: Central Coast Medical Oncology
state: California
city: Santa Monica
country: United States
facility: UCLA Healthcare Hematology-Oncology
state: California
city: Santa Rosa
country: United States
facility: St. Joseph Heritage Healthcare
state: California
city: Whittier
country: United States
facility: Innovative Clinical Research Institute
state: California
city: Whittier
country: United States
facility: Loyola University Medical Center
state: California
city: Glenwood Springs
country: United States
facility: Valley View Hospital
state: Colorado
city: Grand Junction
country: United States
facility: St. Mary'S Hospital Regional Cancer Center
state: Colorado
city: Miami
country: United States
facility: University of Miami Sylvester Comprehensive Cancer Center
state: Florida
city: Miami
country: United States
facility: Advanced Pharma Cr
state: Florida
city: Plantation
country: United States
facility: Boca Raton Clinical Research Medical Inc.
state: Florida
city: Weeki Wachee
country: United States
facility: Asclepes Research Centers
state: Florida
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center of Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center - Consultants in Hematology
state: Illinois
city: Lake Charles
country: United States
facility: Clinical Trials of Swla Llc
state: Louisiana
city: Ann Arbor
country: United States
facility: University of Michigan Cancer Center
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Kansas City
country: United States
facility: Saint Luke'S Hospital of Kansas City
state: Missouri
city: Las Vegas
country: United States
facility: COMPREHENSIVE CANCER CeNTERS OF NEVADA - TWAIN
state: Nevada
city: New Hyde Park
country: United States
facility: Clinical Research Alliance
state: New York
city: New York
country: United States
facility: Nyu Cancer Institute
state: New York
city: Nyack
country: United States
facility: Hematology Oncology Associates of Rockland
state: New York
city: White Plains
country: United States
facility: White Plains Hospital
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Gettysburg
country: United States
facility: Gettysburg Cancer Center
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Hematology Oncology Associates Pa
state: South Carolina
city: The Woodlands
country: United States
facility: Renovatio Clinical
state: Texas
city: Seattle
country: United States
facility: University of Washington - Seattle Cancer Care Alliance
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Rosario
country: Argentina
facility: Aou Maggiore Della Carita
city: Auchenflower
country: Australia
facility: Icon Cancer Care
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: North Adelaide
country: Australia
facility: Calvary North Adelaide Hospital
state: South Australia
city: Brussels
country: Belgium
facility: Cliniques Universitaires Ucl Saint-Luc
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuis Leuven - Gasthuisberg
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Roskilde
country: Denmark
facility: Zealand University Hospital
city: Bobigny
country: France
facility: Avicenne Hospital
city: Creteil
country: France
facility: Centre Hospitalier Universitaire Henri Mondor
city: Limoges Cedex
country: France
facility: Chu Limoges - Hospital Le Cluzeau
city: Paris
country: France
facility: Hopital Saint-Louis
city: Paris
country: France
facility: H�Pital Universitaire Piti�-Salp�Tri�Re
city: Pierre-benite
country: France
facility: Hospices Civils de Lyon Centre Hospitalier Lyon Sud
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Villejuif
country: France
facility: Institute Gustave Roussy (Igr)
city: Essen
country: Germany
facility: Universit�Tsklinikum Essen
city: Gottingen
country: Germany
facility: Universitatsmedizin Gottingen
city: Kiel
country: Germany
facility: Universit�Tsklinikum Schleswig-Holstein
city: Ludwigshafen
country: Germany
facility: Klinikum Ludwigshafen
city: Mainz
country: Germany
facility: Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
city: ULM
country: Germany
facility: Universit�Tsklinikum Ulm
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Hebrew University Medical Center Ein Karem Hadassah
city: Petach Tikva
country: Israel
facility: Rabin Medical Center - Beilinson Hospital
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Bologna
country: Italy
facility: University of Bologna, Institute of Haematology �L. E A. Ser�Gnoli�
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori
city: Milano
country: Italy
facility: Fondazione Centro San Raffaele - Milano
city: Milano
country: Italy
facility: Fondazione Irccs Istituto Nazionale Dei Tumori
city: Monza
country: Italy
facility: Azienda Ospedaliera San Gerardo Di Monza
city: Palermo
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti "Villa Sofia - Cervello"
city: Pescara
country: Italy
facility: Presidio Ospedaliero Pescara
city: Ravenna
country: Italy
facility: Ospedale Delle Croci - Ematologia Ravenna
city: Rome
country: Italy
facility: Sapienza University
city: Gdansk
country: Poland
facility: Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie
city: Gdansk
country: Poland
facility: Szpitale Wojew�Dzkie W Gdyni Sp�?Ka Z Ograniczon? Odpowiedzialno?Ci?
city: Krakow
country: Poland
facility: Malopolskie Centrum Medyczne S.C.
city: Warsaw
country: Poland
facility: Klinika Transplantacji Komorel Krwiotworczych
city: Warszawa
country: Poland
facility: Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie
city: Barcelona
country: Spain
facility: Hospital General Universitari Vall D Hebron
city: Barcelona
country: Spain
facility: Ico Institut Catala D Oncologia
city: Madrid
country: Spain
facility: Hgu Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Universitario Hm Sanchinarro
city: Madrid
country: Spain
facility: Hospital Universitario Quironsalud Madrid
city: Majadahonda
country: Spain
facility: Hospital Puerta de Hierro
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: Maidstone
country: United Kingdom
facility: Kent Oncology Centre - Maidstone Hospital
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
city: Southampton
country: United Kingdom
facility: University of Southampton
Study officials:
affiliation: Incyte Corporation
name: Fred Zheng, MD
role: STUDY_DIRECTOR
References: