Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07709624

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)

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

DLBCL

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tty Biopharm

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

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

-

Treatment and study plan

Minjuvi

Drug

Observation study, collect data only

Primary outcomes

  1. objective response rate (ORR)

    Time frame: 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 outcomes

  1. 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.

  2. OS (Overall Survival)

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

  3. DoR (Duration of Response)

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

  4. 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

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

TTY Biopharm

Industry

Registry information

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Jul 16, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.