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

Diffuse Large B-Cell Lymphoma Clinical Trial

— firmMIND  

Official title:

A Phase 3, Single-Arm, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05429268
• Other study ID #: INCMOR 0208-305
• Status: Recruiting
• Phase: Phase 3
• Start date: December 23, 2022
• Est. completion date: December 24, 2026

Study information

• Verified date: June 2024
• Source: Incyte Corporation
• Contact: Incyte Corporation Call Center (US)
• Phone: 1.855.463.3463
• Email: globalmedinfo[@]incyte.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 81
• Est. completion date: December 24, 2026
• Est. primary completion date: December 24, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Diffuse Large B-Cell Lymphoma
• Large B-Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Bulgaria	Medical University Plovdiv	Plovdiv
Bulgaria	Acibadem Cityclinica Mhat Tokuda	Sofia
Bulgaria	Specialized Hospital For Active Treatment of Oncological Diseases - Sofia District Eood	Sofia
Bulgaria	Umhat Alexandrovska Sofia	Sofia
Bulgaria	Umhat Sv. Ivan Rilski Ead	Sofia
Croatia	Clinical Hospital Dubrava	Zagreb
Croatia	Clinical Hospital Merkur	Zagreb
Croatia	University Hospital Centre Zagreb	Zagreb
Czechia	Fakultni Nemocnice Olomouc	Olomouc
Czechia	Vseobecna Fakultni Nemocnice	Prague 2
Denmark	Aarhus University Hospital	Aarhus
Denmark	Odense University Hospital	Odense
Finland	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
Hungary	National Institute of Oncology	Budapest
Hungary	Semmelweis Egyetem	Budapest
Hungary	University of Debrecen	Debrecen
Hungary	Markhot Ferenc Korhaz	Eger
Hungary	Somogy Medyei Kaposi Mor Oktato Korhaz	Kaposvar
Hungary	Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza	Szeged
Ireland	Bon Secours Hospital	Cork
Ireland	Mater Misericordiae University Hospital	Dublin 7
Ireland	University Hospital Galway	Galway
Israel	Rambam Health Care Campus	Haifa
Israel	Hadassah University Hospital	Jerusalem
Israel	Shaare Zedek Mc	Jerusalem
Israel	Meir Medical Center	Kefar Sava
Norway	Akershus University Hospital	Lorenskog
Norway	Universitetssykehuset I Trondheim - St. Olavs Hospital	Trondheim
Poland	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	Warszawa
Poland	Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego	Wroclaw
Romania	Coltea Clinical Hospital	Bucharest
Romania	Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj-napoca
Romania	Institutul Regional de Oncologie Iasi	Iasi
Romania	Spitalul Clinic Judetean de Urgenta Targu Mures	Targu Mures
Serbia	Clinic For Hematology, University Clinical Center Serbia	Belgrade
Serbia	Clinical Center Kragujevac	Kragujevac
Serbia	Clinic of Hematology Clinical Center of Vojvodina	Novi Sad
Serbia	Institute For Pulmonary Diseases of Vojvodina	Sremska Kamenica
Turkey	Ankara University Medical Faculty	Ankara
Turkey	Gazi University Hospital Gazi University Faculty of Medicine	Ankara
Turkey	Hacettepe University Cancer Institute Clinical Oncology Department	Ankara
Turkey	Ozel Liv Hospital Onkoloji Klinigi	Ankara
Turkey	Marmara Universitesi Pendik Egitim	Istanbul
Turkey	Vkf American Hospital	Istanbul
Turkey	Ege University Hospital	Izmir
Turkey	Ercyes University Medical School	Kayseri
Turkey	Tekrda-Nk Tp Fakltesi	Merkez
Turkey	Mersin University Medical Faculty	Mersin
Turkey	Dr. Abdurrahman Yurtaslan Onkology Teaching and Research Hospitalerciyes Universitesi Tip Faklutesi	Yenimahalle
United Kingdom	Antrim Area Hospital Northern Health Social Care Trust	Antrim
United Kingdom	Belfast Health and Social Care Trust, of Trust Headquarters	Belfast

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

Bulgaria,  Croatia,  Czechia,  Denmark,  Finland,  Hungary,  Ireland,  Israel,  Norway,  Poland,  Romania,  Serbia,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR)	Percentage of participants having best response of Complete Response (CR) or Partial Response (PR) as per Independent Review Committee and investigator's assessment.	Approximately 24 months
Secondary	Duration of Response (DOR)	Defined as the time from the first documented CR or PR until the date of first documented disease progression or death due to any cause, whichever occurs first, among participants who achieve CR or PR per Independent Review Committee (IRC) assessment and investigator's assessment.	Approximately 24 months
Secondary	Progression Free Survial (PFS)	Defined as the time from the date of first dose until the first documented disease progression, or death due to any cause, whichever occurs first per IRC assessment and investigator's assessment.	Approximately 24 months
Secondary	Disease Control Rate (DCR)	Defined as the percentage of participants who achieve CR, PR, or SD as per IRC assessment and investigator's assessment.	Approximately 24 months
Secondary	Time to Next Treatment (TTNT)	Defined as the time from first dose until the initiation of new anticancer therapy or death due to any reason, whichever occurs first.	Approximately 24 months
Secondary	Overall Survival (OS)	Defined as the time from the date of first dose until death due to any cause.	Approximately 24 months
Secondary	Number of treatment-emergent adverse events	Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment up to 90 days after last dose of study treatment.	Approximately 24 months