This is an open-label, randomized, multicentre study to evaluate safety and preliminary efficacy of the human anti-CD19 antibody Tafasitamab in addition to R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) or Tafasitamab and Lenalidomide in addition to R-CHOP in adult patients with newly diagnosed, previously untreated Diffuse Large B-cell Lymphoma (DLBCL).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) in addition to R-CHOP
Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) plus lenalidomide (starting dose 25 mg orally, on Day 1-10) in addition to R-CHOP
Incidence and Severity of Treatment-emergent Adverse Events (TEAEs)
Time frame: 6 months approximately
Objective Response Rate (ORR) at the End of Treatment (EOT)
The ORR at EOT was defined as the proportion of patients with Complete Response (CR) or Partial response (PR) based on the response achieved at the EOT Visit/early treatment discontinuation visit.
Time frame: 6 months approximately
Metabolic, PET-negative Complete Response (CR) Rate at the End of Treatment
Time frame: 6 months approximately
Incidence and Severity of Adverse Events (AEs) in the Follow-up (FU) Period
Time frame: 18 months for non-treatment emergent adverse events, 6 months for treatment emergent adverse events
Best Objective Response Rate (ORR) Until the End of Study (EOS)
The best ORR was defined as the proportion of patients with Complete Response (CR) or Partial Response (PR) as the best response until the EOS.
Time frame: 24 months approximately
Metabolic, PET-negative Complete Response (CR) Rate Until the End of Study
Time frame: 24 months approximately
Progression-free Survival (PFS) at 12 and 24 Months
As many patients had their data censored, due to completing the study without disease progression or death due to any cause, the probability of PFS (%) was used.
Time frame: 24 months approximately
Event-free Survival (EFS) at 12 and 24 Months
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As many patients had their data censored, due to completing the study without disease progression, death due to any cause, or the start of a new anti-lymphoma treatment, the probability of EFS (%) was used.
Time frame: 24 months approximately
Time to Next Anti-lymphoma Treatment (TTNT)
As many patients had their data censored, due to completing the study without needing to receive another anti-lymphoma treatment, the Probability of TTNT (%) was used. Time to next anti-lymphoma treatment survival % estimate was the estimated probability that a patient remained TTNT-free up to the specified point in time.
Time frame: 24 months approximately
Overall Survival at 12 and 24 Months
As many patients had their data censored, due to completing the study without death from any cause, the probability of OS (%) was used.
Time frame: 24 months approximately
Anti-tafasitamab Antibodies Formation
Time frame: 12 months approximately