Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (firmMIND)
Tafasitamab: Tafasitamab will be administered intravenously in 28-day cycles. During Cycles 1 through 3, tafasitamab will be administered weekly on Days 1, 8, 15, and 22; an additional loading dose will be administered on Cycle 1 Day 4. Starting with Cycle 4, tafasitamab will be administered on Days 1 and 15 of each cycle.
Lenalidomide: Participants will self-administer lenalidomide capsules orally on Days 1-21 of each 28-day cycle, up to 12 cycles.
Study summary
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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
Inclusion Criteria:
* Histologically-confirmed diagnosis of any of the following:
1. Diffuse large B-cell lymphoma not otherwise specified
2. T cell/histiocyte-rich large B-cell lymphoma
3. Epstein-Barr virus positive DLBCL of the elderly
4. Grade 3b follicular lymphoma
5. Composite lymphoma with a DLBCL component with a subsequent DLBCL relapse
6. 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:
1. primary mediastinal (thymic) large B-cell lymphoma,
2. Burkitt lymphoma,
3. Primary refractory diffuse large B-cell lymphoma (DLBCL),
4. History of double- or triple-hit DLBCL.
* Participants who, within 30 days prior to Cycle 1 Day 1, have:
1. Not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma-specific therapy
2. Undergone major surgery or suffered from significant traumatic injury
3. Received live vaccines or have an anticipated need for such vaccination while receiving study treatment
4. 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:
1. Known seropositive for or history of active viral infection with HIV.
2. Known positive test result for hepatitis C (HCV antibody serology testing) and a positive test result for HCV RNA.
3. 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
Primary outcome measure(s)
Overall Response Rate (ORR) — Approximately 24 months Percentage of participants having best response of Complete Response (CR) or Partial Response (PR) as per Independent Review Committee and investigator's assessment.
Trial sites (61)
Facility
City
Region
Status
Medical University Plovdiv
Plovdiv
Bulgaria
Acibadem Cityclinica Mhat Tokuda
Sofia
Bulgaria
Umhat Alexandrovska Sofia
Sofia
Bulgaria
Umhat Sv. Ivan Rilski Ead
Sofia
Bulgaria
Specialized Hospital For Active Treatment of Oncological Diseases - Sofia District Eood
Sofia
Bulgaria
Clinical Hospital Dubrava
Zagreb
Croatia
Clinical Hospital Merkur
Zagreb
Croatia
University Hospital Centre Zagreb
Zagreb
Croatia
Fakultni Nemocnice Olomouc
Olomouc
Czechia
Vseobecna Fakultni Nemocnice
Prague
Czechia
Aarhus University Hospital
Aarhus
Denmark
Odense University Hospital
Odense
Denmark
Helsinki University Central Hospital
Helsinki
Finland
Kuopio University Hospital
Kuopio
Finland
Oulu University Hospital
Oulu
Finland
Tampere University Hospital
Tampere
Finland
Turku University Hospital
Turku
Finland
Semmelweis Egyetem
Budapest
Hungary
National Institute of Oncology
Budapest
Hungary
University of Debrecen
Debrecen
Hungary
Markhot Ferenc Korhaz
Eger
Hungary
Somogy Medyei Kaposi Mor Oktato Korhaz
Kaposvár
Hungary
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
Szeged
Hungary
Bon Secours Hospital
Cork
Ireland
Mater Misericordiae University Hospital
Dublin
Ireland
University Hospital Galway
Galway
Ireland
Rambam Health Care Campus
Haifa
Israel
Shaare Zedek Mc
Jerusalem
Israel
Hadassah University Hospital
Jerusalem
Israel
Meir Medical Center
Kefar Sava
Israel
Akershus University Hospital
Lorenskog
Norway
Universitetssykehuset I Trondheim - St. Olavs Hospital
Trondheim
Norway
Szpital Uniwersytecki Nr 2 Im Dr. Jana Biziela
Bydgoszcz
Poland
Medical University of Gdansk
Gdansk
Poland
Szpital Morski Im. Pck Sp. Z O.O
Gdynia
Poland
University Public Hospital Nr 1
Lublin
Poland
Oddzia Kliniczny Hematologii
Olsztyn
Poland
Pratia Poznan
Skórzewo
Poland
Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw
Poland
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego
Wroclaw
Poland
+ 21 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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