Evaluating the Treatment Outcomes of Tafasitamab in Patients With Relapsed/ Refractory Diffuse Large B-cell Lymphoma: a Real-world Evidence Study

N/AActive Not RecruitingNCT07709624

TTY Biopharm50 enrolled

Overview

To evaluate the efficacy of tafasitamab in patients with relapsed/ refractory diffuse large B-cell lymphoma \*To evaluate best objective response rate (ORR)

Study Type

OBSERVATIONAL

Enrollment

Conditions

DLBCL

Interventions

MinjuviDRUG

Observation study, collect data only

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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. \-

Locations (1)

Tty Biopharm

Taipei, Taiwan

Outcomes

Primary Outcomes

objective response rate (ORR)

the proportion of patients achieving a complete or partial response to tafasitamab, based on the Lugano 2014 criteria.

Time frame: The time from day 1 of tafasitamab treatment initiation to documented disease progression or death

Secondary Outcomes

PFS (Progression-Free Survival)

Time frame: defined as the time from day 1 of tafasitamab treatment initiation to documented disease progression or death from any cause.

OS (Overall Survival)

Time frame: the time from day 1 of tafasitamab treatment initiation to death from any cause.

DoR (Duration of Response)

Time frame: the time from day 1 of first documented response (complete or partial) to disease progression or death.

TTP (Time to Progression)

Time frame: 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)

Time frame: 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)

Time frame: 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.

Data from ClinicalTrials.gov

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