DLBCL
Conditions
Brief summary
To evaluate the efficacy of tafasitamab in patients with relapsed/ refractory diffuse large B-cell lymphoma \*To evaluate best objective response rate (ORR)
Interventions
DRUGMinjuvi
Observation study, collect data only
Sponsors
TTY Biopharm
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult patients aged ≥18 years at the time of tafasitamab initiation. 2. Patients who were initiated on tafasitamab treatment between August 1, 2024, and December 31, 2028. 3. Patients with a histologically confirmed diagnosis of DLBCL. 4. Patients ineligible for ASCT based on clinical judgment, comorbidities, or other relevant factors. 5. Patients must have relapsed or refractory disease following at least one prior systemic regimen for DLBCL, with at least one line of therapy including a CD20-targeted agent (e.g., rituximab).
Exclusion criteria
1\. Patients who are alive but unable or unwilling to provide written informed consent. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate (ORR) | The time from day 1 of tafasitamab treatment initiation to documented disease progression or death | the proportion of patients achieving a complete or partial response to tafasitamab, based on the Lugano 2014 criteria. |
Secondary
| Measure | Time frame |
|---|---|
| PFS (Progression-Free Survival) | defined as the time from day 1 of tafasitamab treatment initiation to documented disease progression or death from any cause. |
| OS (Overall Survival) | the time from day 1 of tafasitamab treatment initiation to death from any cause. |
| DoR (Duration of Response) | the time from day 1 of first documented response (complete or partial) to disease progression or death. |
| TTP (Time to Progression) | the time from day 1 of tafasitamab treatment initiation to tumor progression, with deaths censored if occurring prior to progression |
| TTNT (Time to Next Treatment) | the time from day 1 of tafasitamab treatment initiation to the start of the next anti-neoplastic therapy, regardless of the reason (e.g., disease progression, toxicity, or patient preference) or death from any cause. |
| EFS (Event-Free Survival) | the time from day 1 of tafasitamab treatment initiation to the earliest occurrence of tumor progression, initiation of a new non-study anti-neoplastic therapy, or death from any cause. |
Countries
Taiwan
Outcome results
None listed