DLBCL - Diffuse Large B Cell LymphomaNCT07472621
Real-World Effectiveness and Safety of Glofitamab in Primary Refractory and Early Relapsed Diffuse Large B-Cell Lymphoma
An observational study of DLBCL - Diffuse Large B Cell Lymphoma, run by Henan Cancer Hospital at 1 site in China.
Trial summary
This is a prospective, observational, non-interventional real-world study that will not alter participants' routine clinical care. Approximately 20 eligible patients with diffuse large B-cell lymphoma (DLBCL) will be enrolled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DLBCL - Diffuse Large B Cell Lymphoma
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2026to 1 Dec 2028
- How long will I take part?
- 20 Years
- 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: The study population will include adult patients (≥18 years) with histologically confirmed diffuse large B-cell lymphoma (DLBCL) who have primary refractory disease or early relapse after first-line therapy. Eligible patients are those who plan to initiate a glofitamab-containing treatment regimen (either as monotherapy or in combination with other agents) in routine clinical practice. Patients will be enrolled from participating centers and followed prospectively to evaluate treatment outcomes and safety in a real-world setting.
Who may be able to join
- Participants must meet all of the following criteria:
- Age ≥18 years at the time of treatment initiation.
- Histologically or pathologically confirmed diffuse large B-cell lymphoma (DLBCL).
- Patients with primary refractory disease or early relapse, defined as:
- Failure to achieve complete response (CR) after at least 4 cycles of first-line induction therapy, or
- Relapse confirmed by imaging within 12 months after achieving CR following first-line therapy.
- Patients who plan to initiate a glofitamab-containing treatment regimen (either monotherapy or combination therapy) within 12 months after study initiation.
- Willing and able to comply with study follow-up and data collection requirements.
Who cannot join
- Participants meeting any of the following criteria will be excluded:
- Currently participating in, or planning to participate in, any interventional clinical trial.
- Any condition that, in the investigator's judgment, would make the patient unsuitable for participation in this study (e.g., inability to complete follow-up, safety concerns, or significant comorbidities).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Henan cancer hospital
Zhengzhou, Henan, 450008
Keshu Dr Zhou, +86 13674902391, drzhouks77@163.com
About this study
Official title: Efficacy and Safety of Glofitamab in the Real-World Treatment of Patients With Primary Refractory and Early Relapsed Diffuse Large B-Cell Lymphoma
This is a prospective, observational, non-interventional real-world study that will not alter participants' routine clinical care. Approximately 20 eligible patients with diffuse large B-cell lymphoma (DLBCL) will be enrolled. Treatment decisions will be made by the treating physician based on standard clinical practice and may include glofitamab monotherapy or glofitamab-based combination regimens, such as glofitamab plus gemcitabine and oxaliplatin (Glofit-GemOx) or glofitamab plus polatuzumab-based therapy (Glofit-Pola).
The study will collect baseline characteristics (including age, sex, medical history, and molecular subtype), treatment information, laboratory test results, adverse events, and survival follow-up data. Circulating tumor DNA (ctDNA) testing will be performed to assess minimal residual disease (MRD) in peripheral blood. When clinically indicated, cerebrospinal fluid samples may be collected to measure drug concentration.
All personal information will be kept strictly confidential. Identifiable information will be removed and replaced with coded study numbers. Medical records will be maintained at the study site and accessed only by authorized research personnel. Representatives from the sponsor, ethics committee, or regulatory authorities may review study records as required. Study results will be published in aggregated form without including any information that could identify individual participants. Study data and personal information will be used solely for research purposes.
- Conditions
- DLBCL - Diffuse Large B Cell Lymphoma
- Medical subject headings
- Dendritic Cell Sarcoma, Interdigitating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Glofitamab-Based Therapy Cohort | Patients with diffuse large B-cell lymphoma (DLBCL) receiving glofitamab-based therapy in routine clinical practice will be included in this cohort. Treatment regimens are determined by the treating physicians and may include glofitamab monotherapy or glofitamab in combination with chemotherapy or other agents (e.g., GemOx or polatuzumab-based regimens). Clinical data, treatment response, safety outcomes, and circulating tumor DNA (ctDNA) measurements will be prospectively collected and analyzed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
Overall response rate (ORR) is defined as the proportion of patients achieving complete response (CR) or partial response (PR) according to the Lugano criteria for lymphoma. The primary analysis will evaluate ORR at the end of treatment (EOT).
Measured: Up to 6 months
Secondary outcomes (7)
Complete Response Rate (CR Rate)
Complete response (CR) rate is defined as the proportion of patients achieving complete response according to the Lugano criteria for lymphoma.
Measured: Up to 6 months after enrollment
Disease Control Rate (DCR)
Disease control rate (DCR) is defined as the proportion of patients achieving complete response (CR), partial response (PR), or stable disease (SD) according to the Lugano criteria for lymphoma.
Measured: Up to 6 months after enrollment
DoR
Duration of response (DoR) is defined as the time from the first documentation of complete response (CR) or partial response (PR) to disease progression, relapse, or death from any cause.
Measured: Up to 24 months
Progression-Free Survival (PFS)
Progression-free survival (PFS) is defined as the time from initiation of glofitamab treatment to disease progression, relapse, or death from any cause.
Measured: Up to 24 months
Overall Survival (OS)
Overall survival (OS) is defined as the time from initiation of glofitamab treatment to death from any cause.
Measured: Up to 24 months
Incidence of Adverse Events
Safety will be evaluated by assessing the incidence and severity of adverse events (AEs), serious adverse events (SAEs), and grade ≥3 adverse events according to CTCAE version 5.0.
Measured: From treatment initiation to 3 months after the last dose
Time to Next Treatment (TTNT)
Time to next treatment (TTNT) is defined as the time from initiation of glofitamab therapy to the start of the next line of anti-lymphoma treatment.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start10 Mar 2026 (estimated)
- Primary completion7 Mar 2027 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DLBCL - Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, KeshuZhou, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472621
- Sponsor's protocol ID
- 2025-674-IIT-REAL-GLO
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Glofitamab in the Real-World Treatment of Patients With Primary Refractory and Early Relapsed Diffuse Large B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT07472621
- Acronym / sponsor ID
- 2025-674-IIT-REAL-GLO
- Conditions
- DLBCL - Diffuse Large B Cell Lymphoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 10 Mar 2026 (estimated)
- Primary completion
- 7 Mar 2027 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 16 Mar 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.
This is a prospective, observational, non-interventional real-world study that will not alter participants' routine clinical care. Approximately 20 eligible patients with diffuse large B-cell lymphoma (DLBCL) will be enrolled. Treatment decisions will be made by the treating physician based on standard clinical practice and may include glofitamab monotherapy or glofitamab-based combination regimens, such as glofitamab plus gemcitabine and oxaliplatin (Glofit-GemOx) or glofitamab plus polatuzumab-based therapy (Glofit-Pola).
The study will collect baseline characteristics (including age, sex, medical history, and molecular subtype), treatment information, laboratory test results, adverse events, and survival follow-up data. Circulating tumor DNA (ctDNA) testing will be performed to assess minimal residual disease (MRD) in peripheral blood. When clinically indicated, cerebrospinal fluid samples may be collected to measure drug concentration.
All personal information will be kept strictly confidential. Identifiable information will be removed and replaced with coded study numbers. Medical records will be maintained at the study site and accessed only by authorized research personnel. Representatives from the sponsor, ethics committee, or regulatory authorities may review study records as required. Study results will be published in aggregated form without including any information that could identify individual participants. Study data and personal information will be used solely for research purposes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glofitamab-Based Therapy Cohort | – | –Patients with diffuse large B-cell lymphoma (DLBCL) receiving glofitamab-based therapy in routine clinical practice will be included in this cohort. Treatment regimens are determined by the treating physicians and may include glofitamab monotherapy or glofitamab in combination with chemotherapy or other agents (e.g., GemOx or polatuzumab-based regimens). Clinical data, treatment response, safety outcomes, and circulating tumor DNA (ctDNA) measurements will be prospectively collected and analyzed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include adult patients (≥18 years) with histologically confirmed diffuse large B-cell lymphoma (DLBCL) who have primary refractory disease or early relapse after first-line therapy. Eligible patients are those who plan to initiate a glofitamab-containing treatment regimen (either as monotherapy or in combination with other agents) in routine clinical practice. Patients will be enrolled from participating centers and followed prospectively to evaluate treatment outcomes and safety in a real-world setting.
Key inclusion criteria (8 listed)
- Participants must meet all of the following criteria:
- Failure to achieve complete response (CR) after at least 4 cycles of first-line induction therapy, or
- Relapse confirmed by imaging within 12 months after achieving CR following first-line therapy.
Key exclusion criteria (3 listed)
- Participants meeting any of the following criteria will be excluded:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Response Rate (ORR)
Time frame: Up to 6 months
Overall response rate (ORR) is defined as the proportion of patients achieving complete response (CR) or partial response (PR) according to the Lugano criteria for lymphoma. The primary analysis will evaluate ORR at the end of treatment (EOT).
7 secondary outcomes
Complete Response Rate (CR Rate)
Time frame: Up to 6 months after enrollment
Disease Control Rate (DCR)
Time frame: Up to 6 months after enrollment
DoR
Time frame: Up to 24 months
Progression-Free Survival (PFS)
Time frame: Up to 24 months
Overall Survival (OS)
Time frame: Up to 24 months
Incidence of Adverse Events
Time frame: From treatment initiation to 3 months after the last dose
Time to Next Treatment (TTNT)
Time frame: Up to 24 months
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 Mar 2026.
- Individual participant dataSharing planned: No
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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.
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 - Diffuse Large B Cell Lymphoma, run by Henan Cancer Hospital at 1 site in China.
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 8 inclusion and 3 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: opening soon, as of the sponsor's last update on 16 Mar 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 China. 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?
Contact keshu Dr zhou (+86 13674902391, drzhouks77@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: Up to 6 months). 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 Mar 2026.