DLBCLNCT07709624
Evaluating the Treatment Outcomes of Tafasitamab in Patients With Relapsed/ Refractory Diffuse Large B-cell Lymphoma: a Real-world Evidence Study
An observational study of DLBCL, run by TTY Biopharm at 1 site in Taiwan.
Trial summary
To evaluate the efficacy of tafasitamab in patients with relapsed/ refractory diffuse large B-cell lymphoma *To evaluate best objective response rate (ORR) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DLBCL
- What is being tested?
- Minjuvi
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2025to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: R/R DLBCL who are ineligible for ASCT
Who may be able to join
- 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).
Who cannot join
- 1. Patients who are alive but unable or unwilling to provide written informed consent.
- -
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Minjuvi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinjuviDrug
Observation study, collect data only
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate (ORR)
the proportion of patients achieving a complete or partial response to tafasitamab, based on the Lugano 2014 criteria.
Measured: The time from day 1 of tafasitamab treatment initiation to documented disease progression or death
Secondary outcomes (6)
PFS (Progression-Free Survival)
Measured: defined as the time from day 1 of tafasitamab treatment initiation to documented disease progression or death from any cause.
OS (Overall Survival)
Measured: the time from day 1 of tafasitamab treatment initiation to death from any cause.
DoR (Duration of Response)
Measured: the time from day 1 of first documented response (complete or partial) to disease progression or death.
TTP (Time to Progression)
Measured: 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)
Measured: 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)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 Dec 2025
- Primary completion28 Jan 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DLBCLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TTY Biopharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07709624
- Sponsor's protocol ID
- MJ2501
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Treatment Outcomes of Tafasitamab in Patients With Relapsed/ Refractory Diffuse Large B-cell Lymphoma: a Real-world Evidence Study
- ClinicalTrials.gov ID
- NCT07709624
- Acronym / sponsor ID
- MJ2501
- Conditions
- DLBCL
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- TTY BiopharmIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 28 Jan 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy of tafasitamab in patients with relapsed/ refractory diffuse large B-cell lymphoma
*To evaluate best objective response rate (ORR)
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- R/R DLBCL who are ineligible for ASCT
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (2 listed)
- 1. Patients who are alive but unable or unwilling to provide written informed consent.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MinjuviObservation study, collect data only | Drug | – |
Primary outcome
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.
6 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of DLBCL, run by TTY Biopharm at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (ORR) (time frame: The time from day 1 of tafasitamab treatment initiation to documented disease progression or death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.