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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
82
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.
Participants will self-administer lenalidomide capsules orally on Days 1-21 of each 28-day cycle, up to 12 cycles.
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
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.
Time frame: Approximately 24 months
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.
Time frame: Approximately 24 months
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.
Time frame: Approximately 24 months
Disease Control Rate (DCR)
Defined as the percentage of participants who achieve CR, PR, or SD as per IRC assessment and investigator's assessment.
Time frame: Approximately 24 months
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.
Time frame: Approximately 24 months
Overall Survival (OS)
Defined as the time from the date of first dose until death due to any cause.
Time frame: Approximately 24 months
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.
Time frame: Approximately 24 months
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Zagreb, Croatia
Clinical Hospital Merkur
Zagreb, Croatia
University Hospital Centre Zagreb
Zagreb, Croatia
Fakultni Nemocnice Olomouc
Olomouc, Czechia
Vseobecna Fakultni Nemocnice
Prague, Czechia
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