A Study of INCB050465 in Relapsed or Refractory Follicular Lymphoma
- Registration Number
- NCT03126019
- Lead Sponsor
- Incyte Corporation
- Brief Summary
The purpose of this study is to assess the objective response rate of parsaclisib treatment in participants with relapsed or refractory follicular lymphoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 126
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW Parsaclisib Participants received parsaclisib 20 mg once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to approximately 52 weeks. Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD Parsaclisib Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks.
- Primary Outcome Measures
Name Time Method Objective Response Rate With Parsaclisib Based on Lugano Classification Response Criteria Up to approximately 148 weeks 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.
- Secondary Outcome Measures
Name Time Method Complete Response Rate With Parsaclisib Based on Lugano Classification Response Criteria Up to 1193 days 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.
Duration of Response (DOR) Up to 1193 days 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.
Progression-free Survival (PFS) With Parsaclisib Up to 1193 days 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.
Overall Survival (OS) With Parsaclisib Up to 1193 days OS was defined as the time from the date of the first dose of study treatment until death from any cause.
Best Percent Change From Baseline in Target Lesion Size Up to 1193 days 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.
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) up to approximately 1992 days 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.
Trial Locations
- Locations (83)
Florida Cancer Specialists & Research Institute
🇺🇸Fort Myers, Florida, United States
Hattiesburg Clinic Hematology
🇺🇸Hattiesburg, Mississippi, United States
University of Pennsylvania Health System
🇺🇸Philadelphia, Pennsylvania, United States
Synergy Hematology and Oncology Medical Associates
🇺🇸Los Angeles, California, United States
Arizona Oncology Associates - Biltmore Cancer Center
🇺🇸Phoenix, Arizona, United States
Beverly Hills Cancer Center
🇺🇸Beverly Hills, California, United States
St. Joseph Heritage Healthcare
🇺🇸Santa Rosa, California, United States
American Institute of Research Corporate Office
🇺🇸Whittier, California, United States
Cancer Center of Central Connecticut
🇺🇸Southington, Connecticut, United States
Asclepes Research Centers
🇺🇸Spring Hill, Florida, United States
Saint Agnes Hospital
🇺🇸Baltimore, Maryland, United States
Clinical Trials of Swla Llc
🇺🇸Lake Charles, Louisiana, United States
Saint Luke'S Hospital
🇺🇸Kansas City, Missouri, United States
Sarah Cannon Research Institute
🇺🇸Kansas City, Missouri, United States
Clinical Research Alliance, Inc.
🇺🇸New Hyde Park, New York, United States
Gabrail Cancer Center
🇺🇸Canton, Ohio, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Tennessee Oncology
🇺🇸Nashville, Tennessee, United States
Renovatio Clinical Consultants Llc
🇺🇸Spring, Texas, United States
St Vincent'S Hospital Sydney
🇦🇺Darlinghurst, Australia
Sunnybrook Health Science Centre
🇨🇦Toronto, Ontario, Canada
Border Medical Oncology
🇦🇺Wodonga, Victoria, Australia
Santa Cabrini Hospital
🇨🇦Montreal, Quebec, Canada
Saint John Regional Hospital
🇨🇦St. John, New Brunswick, Canada
University Hospital Hradec Kralove
🇨🇿Hradec Kralove, Czechia
Fakultni Nemocnice Ostrava
🇨🇿Ostrava, Czechia
University Hospital Kralovkse Vinohrady
🇨🇿Prague, Czechia
Fakultni Nemocnice V Motole
🇨🇿Praha 5, Czechia
Univerzita Karlova V Praze 1. Lekarska Fakulta
🇨🇿Praha, Czechia
Bag Arnoldstr. Dresden
🇩🇪Dresden, Germany
University Medical Center Freiburg
🇩🇪Freiburg, Germany
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
🇩🇪Mainz, Germany
University Hospital Mannheim
🇩🇪Mannheim, Germany
University of Debrecen
🇭🇺Debrecen, Hungary
Rambam Medical Center
🇮🇱Haifa, Israel
Laniado Hospital Hematology
🇮🇱Netanya, Israel
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
Ospedale San Raffaele
🇮🇹Milano, Italy
Fondazione Irccs Istituto Nazionale Dei Tumori
🇮🇹Milano, 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
San Bartolo Hospital
🇮🇹Vicenza, Italy
Uniwersyteckie Centrum Kliniczne
🇵🇱Gdansk, Poland
Hgu Gregorio Maranon
🇪🇸Madrid, Spain
Md Anderson Cancer Centre Madrid
🇪🇸Madrid, Spain
Hospital de La Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
Hospital General Universitari Vall D Hebron
🇪🇸Barcelona, Spain
Hospital Universitario Ramon Y Cajal
🇪🇸Madrid, Spain
Hospital Universitario de La Paz
🇪🇸Madrid, Spain
Hospital Universitario Hm Sanchinarro
🇪🇸Madrid, Spain
Hospital Universitario Quironsalud Madrid
🇪🇸Madrid, Spain
Hospital Universitario Virgen Del Rocio
🇪🇸Sevilla, Spain
Hospital Universitario de Canarias
🇪🇸San Cristobal de La Laguna, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Karolinska University Hospital, Huddinge
🇸🇪Stockholm, Sweden
Birmingham Heartlands Hospital
🇬🇧Birmingham, United Kingdom
Royal Hallamshire Hospital
🇬🇧Sheffield, United Kingdom
Northwick Park Hospital
🇬🇧London, United Kingdom
The Royal Marsden Nhs Foundation Trust - Chelsea
🇬🇧Sutton, United Kingdom
Hillel Yafe Medical Center (Hymc)
🇮🇱Hadera, Israel
Sheba Medical Center
🇮🇱Ramat Gan, Israel
Somogy Medyei Kaposi Mor Oktato Korhaz
🇭🇺Kaposvar, Hungary
Barbara Ann Karmanos Cancer Hospital
🇺🇸Detroit, Michigan, United States
Western Health
🇦🇺St Albans, Victoria, Australia
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv-yafo, Israel
Charleston Hematology Oncology Associates Pa
🇺🇸Charleston, South Carolina, United States
National Institute of Oncology
🇭🇺Budapest, Hungary
Pratia McM Krakow
🇵🇱Krakow, Poland
State Hospital Opole
🇵🇱Opole, Poland
Institute of Hematology and Transfusion Medicine
🇵🇱Warszawa, Poland
Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie
🇵🇱Warszawa, Poland
University of Washington
🇺🇸Seattle, Washington, United States
Semmelweis Egyetem
🇭🇺Budapest, Hungary
Aalborg University Hospital
🇩🇰Aalborg, Denmark
Odense Universitetshospital (Ouh) (Odense University Hospital)
🇩🇰Odense C, Denmark
Irccs Centro Di Riferimento Oncologico
🇮🇹Aviano, Italy
A.O.U. Di Modena - Policlinico
🇮🇹Modena, Italy
Aou Citta Della Salute E Della Scienza Di Torino
🇮🇹Torino, Italy