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NCT04809467TerminatedPhase 1/2

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)

A Phase 1b/2a Basket Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Combination Therapy With the Anti CD19 Monoclonal Antibody Tafasitamab and the PI3Kδ Inhibitor Parsaclisib in Adult Participants With Relapsed/Refractory Non Hodgkin Lymphoma or Chronic Lymphocytic Leukemia

Source: ClinicalTrials.gov · Last updated 4 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Terminated
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
54 (actual)
First submitted
19 Mar 2021
Start date
16 Sept 2021
Primary completion date
22 Oct 2024
Lead sponsor
Incyte Corporation
NCT number
NCT04809467
EudraCT number
2020-005591-35

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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

Other

  • Any other histological type of lymphoma
  • Primary or secondary CNS lymphoma
  • Currently pregnant or breastfeeding

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (50)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Ordensklinikum Linz GmbH ElisabethinenLinzAustriaUnknown status
Landeskrankenhaus SalzburgSalzburgAustriaUnknown status
Hanusch Krankenhaus der Wiener GebietskrankenkasseViennaAustriaUnknown status
Institut Jules BordetBrusselsBelgiumUnknown status
Grand Hospital de CharleroiCharleroiBelgiumUnknown status
Universitair Ziekenhuis Antwerpen (Uza)EdegemBelgiumUnknown status
AZ Groeninge Campus KennedylaanKortrijkBelgiumUnknown status
Universitair Ziekenhuis (Uz) LeuvenLeuvenBelgiumUnknown status
AZ DeltaRoeselareBelgiumUnknown status
University Medical Center FreiburgFreiburg im BreisgauGermanyUnknown status
Justus-Liebig UniversityGiessenGermanyUnknown status
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz IiiMainzGermanyUnknown status
University Hospital WürzburgWürzburgGermanyUnknown status
Hospital General Unviersitario de AlicanteAlicanteSpainUnknown status
Hopital Sant PauBarcelonaSpainUnknown status
ICO Institut Catala d'OncologiaBarcelonaSpainUnknown status
Hospital General Universitario Vall D HebronBarcelonaSpainUnknown status
Hospital Universitario San CecilioGranadaSpainUnknown status
Hospital Universitario Quirónsalud MadridMadridSpainUnknown status
Centro Integral Oncológico Clara Campal (CIOCC)MadridSpainUnknown status
Hospital Universitario 12 de OctubreMadridSpainUnknown status
Hospital Puerta de HierroMajadahondaSpainUnknown status
Hospital Universitario Central De AsturiasOviedoSpainUnknown status
Hospital Clinico Universitario de SalamancaSalamancaSpainUnknown status
Hospital Universitario Marqués de ValdecillaSantanderSpainUnknown status
Hospital Universitario Virgen del RocioSevilleSpainUnknown status
Hospital General Universitario de ValenciaValenciaSpainUnknown status
University Hospital BrestBrestFranceUnknown status
Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-DieuNantesFranceUnknown status
Centre Henri BecquerelRouenFranceUnknown status
Institut Gustave RoussyVillejuifFranceUnknown status
S Orsolas University Hospital Seragnoli Institute of HematologyBolognaItalyUnknown status
Istituto Romagnolo per lo studio dei Tumori "Dino Amadori"MeldolaItalyUnknown status
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano NiguardaMilanItalyUnknown status
Fondazione IRCCS - Istituto Nazionale dei TumoriMilanItalyUnknown status
Istituto Nazionale Tumori IRCCS Fondazione PascaleNaplesItalyUnknown status
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - CervelloPalermoItalyUnknown status
Azienda Ospedaliero Universitaria PisanaPisaItalyUnknown status
Ospedale Santa Maria delle CrociRavennaItalyUnknown status
IRCCS Istituto Clinico HumanitasRozzanoItalyUnknown status
University of MichiganAnn ArborUnited StatesUnknown status
Cancer Center For Blood DisordersBethesdaUnited StatesUnknown status
University of Alabama at Birmingham, Comprehensive Cancer CenterBirminghamUnited StatesUnknown status
Ohio State UniversityColumbusUnited StatesUnknown status
Indiana Blood and Marrow TransplantationIndianapolisUnited StatesUnknown status
Community Health Network, IncIndianapolisUnited StatesUnknown status
University of Southern CaliforniaLos AngelesUnited StatesUnknown status
Norton Cancer InstituteLouisvilleUnited StatesUnknown status
Clinical Research AllianceNew Hyde ParkUnited StatesUnknown status
Jefferson University HospitalsPhiladelphiaUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.