Clinical trial NCT04809467: 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)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Lymphocytic Leukemia
Non Hodgkin Lymphoma
Keywords: Relapsed or Refractory
Leukemia
tafasitamab
parsaclisib
MOR00208
INCMOR00208
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2021-03-22
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Phase 1b : Number of Treatment Emergent Adverse Events
timeFrame: Up to 25 months
measure: Phase 1b : Incidence of Dose Limiting Toxicities
timeFrame: 28 Days
Secondary outcomes:
measure: Phase 2a : Overall Response Rate
timeFrame: Up to 25 months
measure: Pharmacokinetics Parameter : Cmax of tafasitamab
timeFrame: Up to 24 months
measure: Pharmacokinetics Parameter : Cmin of tafasitamab
timeFrame: Up to 24 months
measure: Pharmacokinetics Parameter : Tmax of tafasitamab
timeFrame: Up to 24 months
measure: Pharmacokinetics Parameter : AUC(t) of tafasitamab
timeFrame: Up to 24 months
measure: Pharmacokinetics Parameter : Ctrough of tafasitamab
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama At Birmingham Comprehensive Cancer Center
state: Alabama
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Indianapolis
country: United States
facility: Indiana Blood and Marrow Transplantation
state: Indiana
city: Indianapolis
country: United States
facility: Community Health Network, Inc.
state: Indiana
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Bethesda
country: United States
facility: Cancer Center For Blood Disorders
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: New Hyde Park
country: United States
facility: Clinical Research Alliance
state: New York
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: Jefferson University Hospitals
state: Pennsylvania
city: Linz
country: Austria
facility: Ordensklinikum Linz Gmbh Elisabethinen
city: Salzburg
country: Austria
facility: Landeskrankenhaus Salzburg
city: Vienna
country: Austria
facility: Hanusch-Krankenhaus Der Wiener Gebietskrankenkasse
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Charleroi
country: Belgium
facility: Grand Hospital de Charleroi
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen (Uza)
city: Kortrijk
country: Belgium
facility: Az Groeninge Campus Kennedylaan
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis (Uz) Leuven
city: Roeselare
country: Belgium
facility: AZ DELTA
city: Brest
country: France
facility: University Hospital Brest
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Freiburg
country: Germany
facility: University Medical Center Freiburg
city: Giessen
country: Germany
facility: Justus-Liebig University
city: Mainz
country: Germany
facility: Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
city: Wurzburg
country: Germany
facility: University Hospital Wurzburg
city: Bologna
country: Italy
facility: S Orsolas University Hospital Seragnoli Institute of Hematology
city: Meldola
country: Italy
facility: Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori
city: Milan
country: Italy
facility: Fondazione Irccs Istituto Nazionale Dei Tumori
city: Milan
country: Italy
facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
city: Naples
country: Italy
facility: Istituto Nazionale Tumori Irccs Fondazione Pascale
city: Palermo
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Ravenna
country: Italy
facility: Ospedale Santa Maria Delle Croci
city: Rozzano
country: Italy
facility: Irccs Istituto Clinico Humanitas
city: Alicante
country: Spain
facility: Hospital General Unviersitario de Alicante
city: Barcelona
country: Spain
facility: Hospital General Universitario Vall D Hebron
city: Barcelona
country: Spain
facility: Hopital Sant Pau
city: Barcelona
country: Spain
facility: Ico Institut Catala D Oncologia
city: Granada
country: Spain
facility: Hospital Universitario San Cecilio
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Centro Integral Oncologico Clara Campal (Ciocc)
city: Madrid
country: Spain
facility: Hospital Universitario Quironsalud Madrid
city: Majadahonda
country: Spain
facility: Hospital Puerta de Hierro
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Salamanca
country: Spain
facility: Hospital Clinico Universitario de Salamanca
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
Study officials:
affiliation: Incyte Corporation
name: Oliver Manzke, MD
role: STUDY_DIRECTOR
References: