A Study Evaluating Safety, PK, and Efficacy of Tafasitamab and Parsaclisib in Participants With Relapsed/Refractory Non Hodgkin Lymphoma (R/R NHL) or Chronic Lymphocytic Leukemia (CLL)
NCT ID: NCT04809467
Last Updated: 2025-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
54 participants
INTERVENTIONAL
2021-09-16
2024-10-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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tafasitamab + parsaclisib
Participants will be assigned to disease specific cohorts based on the histology of their underlying disease.
Cohort 1: R/R DLBCL Cohort 2: R/R MCL Cohort 3: R/R FL Cohort 4: R/R MZL Cohort 5: R/R CLL/SLL
tafasitamab
tafasitamab will be administered at a protocol defined dose once a week for cycles 1-3 and every other week from cycle 4 until progression.
parsaclisib
parsaclisib will be administered at protocol defined dose for cycles 1 through disease progression.
Interventions
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tafasitamab
tafasitamab will be administered at a protocol defined dose once a week for cycles 1-3 and every other week from cycle 4 until progression.
parsaclisib
parsaclisib will be administered at protocol defined dose for cycles 1 through disease progression.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willingness to undergo biopsy
* At least 2 prior systemic treatment regimens, including prior treatment with an anti-CD20 antibody (all cohorts) or prior treatment with a BTK inhibitor (CLL/SLL)
* Relapsed, progressive, or refractory NHL or CLL
* For NHL/SLL: Radiographically measurable nodal or extranodal disease (all cohorts except CLL)
* ECOG-PS 0 - 2
* LVEF ≥ 50%
* Adequate renal, hepatic, bone marrow function
Exclusion Criteria
* Primary or secondary CNS lymphoma
* Anticancer and/or investigational therapy within the past 30 days or 5 half-lives
* Allogeneic stem cell transplantation within the past 6 months, or ASCT within 3 months before C1D1
* Previous treatment with CD19-targeted therapy or PI3K inhibitors
* Clinically significant cardiac disease
* Other malignancy within the past 3 years
* Active graft-versus-host disease
* Stroke or intracranial hemorrhage within the past 6 months
* Chronic or current active infectious disease
* Positive virus serology for HCV, HBV, HIV
* Currently pregnant or breastfeeding
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Oliver Manzke, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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University of Alabama At Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
University of Southern California
Los Angeles, California, United States
Indiana Blood and Marrow Transplantation
Indianapolis, Indiana, United States
Community Health Network, Inc.
Indianapolis, Indiana, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Cancer Center For Blood Disorders
Bethesda, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Clinical Research Alliance
New Hyde Park, New York, United States
Ohio State University
Columbus, Ohio, United States
Jefferson University Hospitals
Philadelphia, Pennsylvania, United States
Ordensklinikum Linz Gmbh Elisabethinen
Linz, , Austria
Landeskrankenhaus Salzburg
Salzburg, , Austria
Hanusch-Krankenhaus Der Wiener Gebietskrankenkasse
Vienna, , Austria
Institut Jules Bordet
Brussels, , Belgium
Grand Hospital de Charleroi
Charleroi, , Belgium
Universitair Ziekenhuis Antwerpen (Uza)
Edegem, , Belgium
Az Groeninge Campus Kennedylaan
Kortrijk, , Belgium
Universitair Ziekenhuis (Uz) Leuven
Leuven, , Belgium
AZ DELTA
Roeselare, , Belgium
University Hospital Brest
Brest, , France
Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
Nantes, , France
Centre Henri Becquerel
Rouen, , France
Institut Gustave Roussy
Villejuif, , France
University Medical Center Freiburg
Freiburg im Breisgau, , Germany
Justus-Liebig University
Giessen, , Germany
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
Mainz, , Germany
University Hospital Wurzburg
Würzburg, , Germany
S Orsolas University Hospital Seragnoli Institute of Hematology
Bologna, , Italy
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori
Meldola, , Italy
Fondazione Irccs Istituto Nazionale Dei Tumori
Milan, , Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Istituto Nazionale Tumori Irccs Fondazione Pascale
Naples, , Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
Palermo, , Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, , Italy
Ospedale Santa Maria Delle Croci
Ravenna, , Italy
Irccs Istituto Clinico Humanitas
Rozzano, , Italy
Hospital General Unviersitario de Alicante
Alicante, , Spain
Hospital General Universitario Vall D Hebron
Barcelona, , Spain
Hopital Sant Pau
Barcelona, , Spain
Ico Institut Catala D Oncologia
Barcelona, , Spain
Hospital Universitario San Cecilio
Granada, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Centro Integral Oncologico Clara Campal (Ciocc)
Madrid, , Spain
Hospital Universitario Quironsalud Madrid
Madrid, , Spain
Hospital Puerta de Hierro
Majadahonda, , Spain
Hospital Universitario Central de Asturias
Oviedo, , Spain
Hospital Clinico Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario Marques de Valdecilla
Santander, , Spain
Hospital Universitario Virgen Del Rocio
Seville, , Spain
Hospital General Universitario de Valencia
Valencia, , Spain
Countries
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Other Identifiers
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2020-005591-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INCMOR 0208-101
Identifier Type: -
Identifier Source: org_study_id
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