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

To evaluate the efficacy of tafasitamab in patients with relapsed/ refractory diffuse large B-cell lymphoma

*To evaluate best objective response rate (ORR)

Study Overview

• Status: Active, not recruiting
• Conditions: DLBCL
• Intervention / Treatment: Drug: Minjuvi

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Tty Biopharm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

R/R DLBCL who are ineligible for ASCT

Description

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.

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Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
objective response rate (ORR)	the proportion of patients achieving a complete or partial response to tafasitamab, based on the Lugano 2014 criteria.	The time from day 1 of tafasitamab treatment initiation to documented disease progression or death

Secondary Outcome Measures

Outcome 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.

Collaborators and Investigators

• Sponsor: TTY Biopharm

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): January 28, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: July 7, 2026
• First Submitted That Met QC Criteria: July 13, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: MJ2501

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No