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

NCT07709624 | Active Not Recruiting

• 1 other identifier: MJ2501
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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)

Conditions

DLBCL

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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.

Interventions

Minjuvi DRUG

Observation study, collect data only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

R/R DLBCL who are ineligible for ASCT

You may qualify if:

• Adult patients aged ≥18 years at the time of tafasitamab initiation.
• Patients who were initiated on tafasitamab treatment between August 1, 2024, and December 31, 2028.
• Patients with a histologically confirmed diagnosis of DLBCL.
• Patients ineligible for ASCT based on clinical judgment, comorbidities, or other relevant factors.
• 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).

You may not qualify if:

• \. Patients who are alive but unable or unwilling to provide written informed consent.

Sponsors & Collaborators

• TTY Biopharm: lead

Study Sites (1)

Tty Biopharm

Taipei, Taiwan

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 16, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): January 28, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: July 16, 2026

Record last verified: 2026-07

Locations

TW (1)