A Phase 1b/2, Open-Label, Multicenter Study to Evaluate the Safety and Pharmacokinetics of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Who is this study for? Patients with Diffuse Large B Cell Lymphoma
What treatments are being studied? Tafasitamab+Lenalidomide
Status: Active_not_recruiting
Location: See all (57) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

This is an open-label, multicentre study too Evaluate the Safety and Pharmacokinetics of a Modified Tafasitamab IV Dosing Regimen Combined with Lenalidomide (LEN) in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) who have had at least one, but no more than three prior systemic regimens and who are not eligible for high dose chemotherapy (HDC) with autologous stem-cell transplantation (ASCT) at the time of study entry.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• Capable of giving signed informed consent

• Age 18 years or older

• Histologically confirmed diagnosis of DLBCL

• Tumor tissue for retrospective central pathology review must be provided as an adjunct to participation in this study.

• Patients must have:

‣ relapsed and/or refractory disease

⁃ at least one bidimensionally measurable, PET positive disease site (transverse diameter of ≥1.5 cm and perpendicular diameter of ≥1.0 cm at baseline)

⁃ received at least one, but no more than three previous systemic regimens for the treatment of DLBCL and one therapy line must have included a CD20-targeted therapy

⁃ Eastern Cooperative Oncology Group 0 to 2

• Patients not considered in the opinion of the investigator eligible to undergo intensive salvage therapy including ASCT

• Patients must meet the following laboratory criteria at screening:

‣ absolute neutrophil count ≥1.5 × 10\^9/L

⁃ platelet count ≥90 × 10\^9/L

⁃ total serum bilirubin ≤2.5 × ULN or ≤5 × ULN in cases of Glibert's Syndrome or liver involvement by lymphoma

⁃ alanine transaminase, aspartate aminotransferase and alkaline phosphatase ≤3 × ULN or \<5 × ULN in cases of liver involvement

⁃ serum creatinine clearance ≥ 60 mL/minute

• Patients who received previous CD19 targeted therapy (other than tafasitamab) must have CD19 positive lymphoma confirmed on a biopsy taken since completing the prior CD19 targeted therapy

• Patients with primary refractory disease who received at least one, but no more than three previous systemic regimens (including a CD20 targeted therapy)

Locations
United States
New Jersey
Morristown Memorial Hospital
Morristown
Texas
Texas Oncology-Baylor Charles A. Sammons Cancer Center - USOR
Dallas
Washington
Vista Oncology
Olympia
Other Locations
Austria
Universitatsklinikum Salzburg
Salzburg
UK St. Pölten
Sankt Pölten
Klinikum Wels Grieskirchen
Wels
France
Centre Hospitalier Universitaire Grenoble Alpes - Hopital Albert Michallon
Grenoble
Centre Hospitalier Le Mans
Le Mans
CHU Nantes
Nantes
CHU de Poitiers
Poitiers
Israel
Shamir Medical Center Assaf Harofeh
Be’er Ya‘aqov
Soroka University Medical Centre
Beersheba
Lady Davis Carmel Medical Center
Haifa
Hadassah Medical Center - Hadassah Ein Kerem
Jerusalem
ZIV Medical Center
Safed
Italy
Fondazione del Piemonte per l'Oncologia (IRCCS)
Candiolo
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda
Milan
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan
ASST di Monza - Azienda Ospedaliera San Gerardo
Monza
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia
Azienda Ospedaliera di Perugia
Perugia
Azienda Ospedaliero Universitaria Pisana
Pisa
Ospedale Santa Maria Delle Croci
Ravenna
Poland
Szpitale Pomorskie Sp. z o. o.
Gdynia
Pratia MCM Krakow
Krakow
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Lodz
SPZOZ MiSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie
Olsztyn
Szpital Wojewodzki w Opolu
Opole
Centrum Medyczne Poznan - PRATIA - PPDS
Skórzewo
Nasz Lekarz Osrodek Badan Klinicznych
Torun
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
Warsaw
Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii
Wroclaw
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu
Wroclaw
Republic of Korea
Dong-A University Medical Center
Busan
Kosin University Gospel Hospital
Busan
Pusan National University Hospital
Busan
Daegu Catholic University Medical Center
Daegu
Yeungnam University Hospital
Daegu
Gachon University Gil Medical Center
Incheon
Chonbuk National University Hospital
Jeonju
Asan Medical Center - PPDS
Seoul
Hanyang University Medical Center
Seoul
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul
The Catholic University of Korea, St. Vincent's Hospital
Suwon
Ulsan University Hospital
Ulsan
Spain
Institut Catala d'Oncologia Girona
Girona
ICO l'Hospitalet - Hospital Duran i Reynals
L'hospitalet De Llobregat
Hospital U. Infanta Leonor
Madrid
Hospital U. Quironsalud Madrid
Madrid
Hospital U. Ramon y Cajal
Madrid
Hospital Universitario Fundacion Jimenez Diaz
Madrid
MD Anderson Madrid
Madrid
Hospital Son Llatzer
Palma De Mallorca
Complejo Asistencial Universitario de Salamanca - H. Clinico
Salamanca
Hospital U. Virgen del Rocio
Seville
Hospital Universitari La Fe
Valencia
Time Frame
Start Date: 2022-07-19
Completion Date: 2027-11-30
Participants
Target number of participants: 53
Treatments
Experimental: Treatment (Tafasitamab + Lenalidomide)
Treatment:~Tafasitamab will be combined with lenalidomide in R/R DLBCL patients.~Dose:~Cohort 1: The dose of tafasitamab will be level 1 high dose in combination with the approved dose~Cohort 2: The dose of tafasitamab will be level 2 high dose in combination with the approved dose~Expansion Cohort: The dose of tafasitamab will be the dose that is deemed safe and tolerable as determined from cohort 1 \& cohort 2~Treatment consisting of tafasitamab and lenalidomide combination will be administered until disease progression, unacceptable toxicity, or discontinuation for any other reason, whichever comes first. Lenalidomide can be given for up to 12 cycles in total, after which patients can continue with tafasitamab as monotherapy until progression or unacceptable toxicity.
Sponsors
Leads: Incyte Corporation

This content was sourced from clinicaltrials.gov