Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (firmMIND)

Save

Report Abuse

Description

The purpose of this study is to assess the efficacy and safety of of tafasitamab plus lenalidomide in adults with diffuse large B-cell lymphoma (DLBCL) who have relapsed or are refractory to at least 1 but no more than 3 previous systemic DLBCL treatment regimens and who are not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT).

Study Overview

Start Date
December 23, 2022
Completion Date
December 24, 2026
Enrollment
81
Date Posted
June 23, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Medical University Plovdiv
Plovdiv 04000, Bulgaria

Acibadem Cityclinica Mhat Tokuda
Sofia 01407, Bulgaria

Umhat Alexandrovska Sofia
Sofia 01431, Bulgaria

Umhat Sv. Ivan Rilski Ead
Sofia 01431, Bulgaria

Specialized Hospital For Active Treatment of Oncological Diseases - Sofia District Eood
Sofia 01756, Bulgaria

Clinical Hospital Dubrava
Zagreb 10000, Croatia

University Hospital Centre Zagreb
Zagreb 10000, Croatia

Fakultni Nemocnice Olomouc
Olomouc 779 00, Czechia

Vseobecna Fakultni Nemocnice
Prague 2 128 00, Czechia

Aarhus University Hospital
Aarhus 08200, Denmark

Odense University Hospital
Odense 05000, Denmark

Helsinki University Central Hospital
Helsinki FI-00029, Finland

Kuopio University Hospital
Kuopio 70210, Finland

Oulu University Hospital
Oulu 90420, Finland

Tampere University Hospital
Tampere 33520, Finland

Turku University Hospital
Turku 20520, Finland

Semmelweis Egyetem
Budapest 01088, Hungary

National Institute of Oncology
Budapest 01122, Hungary

University of Debrecen
Debrecen 04032, Hungary

Markhot Ferenc Korhaz
Eger 03300, Hungary

Somogy Medyei Kaposi Mor Oktato Korhaz
Kaposvar 07400, Hungary

Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
Szeged 06725, Hungary

Bon Secours Hospital
Cork T12 DV56, Ireland

Mater Misericordiae University Hospital
Dublin 7 D07AX57, Ireland

Rambam Health Care Campus
Haifa 31096, Israel

Shaare Zedek Mc
Jerusalem 9103102, Israel

Hadassah University Hospital
Jerusalem 92210, Israel

Meir Medical Center
Kefar Sava 44281, Israel

Akershus University Hospital
Lorenskog 01478, Norway

Szpital Uniwersytecki Nr 2 Im Dr. Jana Biziela
Bydgoszcz 85-168, Poland

Medical University of Gdansk
Gdansk 80-211, Poland

Szpital Morski Im. Pck Sp. Z O.O
Gdynia 81-519, Poland

University Public Hospital Nr 1
Lublin 20-081, Poland

Pratia Poznan
Skórzewo 60-185, Poland

Maria Sklodowska-Curie National Research Institute of Oncology
Warszawa 02-0781, Poland

Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego
Wroclaw 50-367, Poland

Coltea Clinical Hospital
Bucharest 30167, Romania

Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
Cluj-napoca 400015, Romania

Institutul Regional de Oncologie Iasi
Iasi 700483, Romania

Spitalul Clinic Judetean de Urgenta Targu Mures
Targu Mures 540136, Romania

Clinic For Hematology, University Clinical Center Serbia
Belgrade 11000, Serbia

Clinical Center Kragujevac
Kragujevac 34000, Serbia

Clinic of Hematology Clinical Center of Vojvodina
Novi Sad 21000, Serbia

Institute For Pulmonary Diseases of Vojvodina
Sremska Kamenica 21204, Serbia

Hacettepe University Cancer Institute Clinical Oncology Department
Ankara 06230, Turkey

Gazi University Hospital Gazi University Faculty of Medicine
Ankara 06560, Turkey

Ankara University Medical Faculty
Ankara 06629, Turkey

Ozel Liv Hospital Onkoloji Klinigi
Ankara 06680, Turkey

Vkf American Hospital
Istanbul 34365, Turkey

Marmara Universitesi Pendik Egitim
Istanbul 34899, Turkey

Tekrda-Nk Tp Fakltesi
Merkez 59030, Turkey

Mersin University Medical Faculty
Mersin 33000, Turkey

Dr. Abdurrahman Yurtaslan Onkology Teaching and Research Hospital
Yenimahalle 06200, Turkey

Eligibility

Minimum Age (years)
18
Maximum Age (years)
99
Eligibility Criteria
Inclusion Criteria:

Histologically-confirmed diagnosis of any of the following:

Diffuse large B-cell lymphoma not otherwise specified
T cell/histiocyte-rich large B-cell lymphoma
Epstein-Barr virus positive DLBCL of the elderly
Grade 3b follicular lymphoma
Composite lymphoma with a DLBCL component with a subsequent DLBCL relapse
Evidence of histological transformation from an earlier diagnosis of low grade lymphoma (ie, an indolent pathology such as follicular lymphoma, marginal zone lymphoma, chronic lymphocytic leukemia) into DLBCL, with a subsequent DLBCL relapse
Willingness to undergo tumor biopsy requirements for the study, (or have archival lymph node or tissue block from the most recent biopsy, not to exceed 3 years prior to C1D1).
Willingness to undergo bone marrow biopsy/aspirate collections.
History of relapsed/progressive/recurrent disease according to the International Working Group response criteria after the most recent systemic therapy.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Adequate hematologic, hepatic, and renal function,
Left ventricular ejection fraction (LVEF) ≥ 50%,
Willingness to avoid pregnancy or fathering children,

Exclusion Criteria:

Any other histological type of lymphoma according to the WHO 2016 classification of lymphoid neoplasms, including:

primary mediastinal (thymic) large B-cell lymphoma,
Burkitt lymphoma,
Primary refractory diffuse large B-cell lymphoma (DLBCL),
History of double- or triple-hit DLBCL.

Participants who, within 30 days prior to Cycle 1 Day 1, have:

Not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma-specific therapy
Undergone major surgery or suffered from significant traumatic injury
Received live vaccines or have an anticipated need for such vaccination while receiving study treatment
Required parenteral antimicrobial therapy for active, intercurrent infections
Have undergone ASCT within the period ≤ 3 months prior to signing consent.
Have undergone previous allogenic stem cell transplantation.
Inadequate recovery (> Grade 1) from prior treatment toxicity and/or complications from major surgery before Cycle 1 Day 1.
Have a history of deep venous thrombosis/embolism, threatening thromboembolism or known thrombophilia or are at high risk for a thromboembolic event in the opinion of the investigator and who are not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period.
Prior history of malignancies other than DLBCL, unless disease-free for ≥ 5 years prior to screening.
Clinically significant cardiac disease, including unstable angina, acute myocardial infarction, New York Heart Association Class II to IV congestive heart failure, uncontrolled arrhythmia, and/or cardiac conduction issues, within 6 months of Cycle 1 Day 1.

Any of the following positive tests:

Known seropositive for or history of active viral infection with HIV.
Known positive test result for hepatitis C (HCV antibody serology testing) and a positive test result for HCV RNA.
Known positive test results for chronic HBV infection (defined by HBsAg positivity). Participants with occult or prior HBV infection (defined as negative HBsAg and positive total HBcAb) may be included if HBV DNA was undetectable

Study Contact Info

Study Contact Name
Incyte Corporation Call Center (US); Incyte Corporation Call Center (ex-US)
Study Contact Phone

Contact Listings Owner Form

Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (firmMIND) 0 reviews

Write Your Review

There are no reviews yet.

Write Your Review

Your email address will not be published. Required fields are marked *

Other Details

FDA Regulated Drug?
Yes
FDA Regulated Device?
No
NCTid (if applicable)
NCT05429268