Non Hodgkin Lymphoma Clinical Trial

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)

Summary

The purpose of this single-arm, open-label, Phase 1b/2a, multicenter basket study is to evaluate whether tafasitamab and parsaclisib can be safely combined at the recommended Phase 2 dose (RP2D) and dosing regimen that was established for each of the 2 compounds as a treatment option for adult participants with R/R B-cell malignancies.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed R/R B-cell malignancy: DLBCL (THRLBCL, EBV-positive DLBCL of the elderly, Grade 3b FL, HGBL with MYC and BCL2 and/or BCL6 rearrangements, transformed lymphoma); MCL ((with cyclin D1 overexpression or t(11;14); FL (Grade 1, 2, 3a); MZL (extranodal, nodal, splenic) ; CLL, or SLL
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:

Any other histological type of lymphoma
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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

54

Study ID:

NCT04809467

Recruitment Status:

Active, not recruiting

Sponsor:

Incyte Corporation

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 50 Locations for this study

See Locations Near You

University of Alabama At Birmingham Comprehensive Cancer Center
Birmingham Alabama, 35205, United States
University of Southern California
Los Angeles California, 90089, United States
Indiana Blood and Marrow Transplantation
Indianapolis Indiana, 46237, United States
Community Health Network, Inc.
Indianapolis Indiana, 46250, United States
Norton Cancer Institute
Louisville Kentucky, 40202, United States
Cancer Center For Blood Disorders
Bethesda Maryland, 20817, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
Clinical Research Alliance
New Hyde Park New York, 11042, United States
Ohio State University
Columbus Ohio, 43210, United States
Jefferson University Hospitals
Philadelphia Pennsylvania, 19107, United States
Ordensklinikum Linz Gmbh Elisabethinen
Linz , A-402, Austria
Landeskrankenhaus Salzburg
Salzburg , 05020, Austria
Hanusch-Krankenhaus Der Wiener Gebietskrankenkasse
Vienna , 01140, Austria
Institut Jules Bordet
Brussels , B-107, Belgium
Grand Hospital de Charleroi
Charleroi , 06000, Belgium
Universitair Ziekenhuis Antwerpen (Uza)
Edegem , 02650, Belgium
Az Groeninge Campus Kennedylaan
Kortrijk , 08500, Belgium
Universitair Ziekenhuis (Uz) Leuven
Leuven , 03000, Belgium
AZ DELTA
Roeselare , 08800, Belgium
University Hospital Brest
Brest , 29609, France
Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
Nantes , 44093, France
Centre Henri Becquerel
Rouen , 76038, France
Institut Gustave Roussy
Villejuif , 94805, France
University Medical Center Freiburg
Freiburg , 79106, Germany
Justus-Liebig University
Giessen , 35392, Germany
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
Mainz , 55131, Germany
University Hospital Wurzburg
Wurzburg , 97080, Germany
S Orsolas University Hospital Seragnoli Institute of Hematology
Bologna , 40138, Italy
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori
Meldola , 47014, Italy
Fondazione Irccs Istituto Nazionale Dei Tumori
Milan , 20133, Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan , 20162, Italy
Istituto Nazionale Tumori Irccs Fondazione Pascale
Naples , 80131, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
Palermo , 90146, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa , 56126, Italy
Ospedale Santa Maria Delle Croci
Ravenna , 48121, Italy
Irccs Istituto Clinico Humanitas
Rozzano , 20089, Italy
Hospital General Unviersitario de Alicante
Alicante , 03010, Spain
Hospital General Universitario Vall D Hebron
Barcelona , 08035, Spain
Hopital Sant Pau
Barcelona , 08036, Spain
Ico Institut Catala D Oncologia
Barcelona , 08908, Spain
Hospital Universitario San Cecilio
Granada , 18016, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Centro Integral Oncologico Clara Campal (Ciocc)
Madrid , 28050, Spain
Hospital Universitario Quironsalud Madrid
Madrid , 28223, Spain
Hospital Puerta de Hierro
Majadahonda , 28222, Spain
Hospital Universitario Central de Asturias
Oviedo , 33011, Spain
Hospital Clinico Universitario de Salamanca
Salamanca , 37007, Spain
Hospital Universitario Marques de Valdecilla
Santander , 39008, Spain
Hospital Universitario Virgen Del Rocio
Sevilla , 41015, Spain
Hospital General Universitario de Valencia
Valencia , 46014, Spain

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

54

Study ID:

NCT04809467

Recruitment Status:

Active, not recruiting

Sponsor:


Incyte Corporation

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.