DLBCL - Diffuse Large B Cell LymphomaNCT06481826
Glofitamab in Chinese Patients With R/R DLBCL
An observational study of DLBCL - Diffuse Large B Cell Lymphoma, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This study will evaluate the safety and efficacy of glofitamab as a single agent in Chinese patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have failed two or more lines of systemic therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- DLBCL - Diffuse Large B Cell Lymphoma
- What is being tested?
- Glofitamab
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2028
- How long will I take part?
- 3 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Who may be able to join
- Histologically-confirmed DLBCL
- Participants must have relapsed or failed to respond to at least two lines of prior systemic therapy
- Participants must have measurable disease
Who cannot join
- Pregnancy or breastfeeding
- Patient with known active infection, or reactivation of a latent infection
- Patient with active autoimmune disease or immune deficiency
- severe organ failure：LVEF<40%；DLCO<40%；eGFR<30ml/min；Bilirubin≥3ULN
- Patients who are dependent on the sponsor, the investigator or the trial site
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, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Wei Zhang, zhangwei3840@126.com
About this study
Official title: A Study to Evaluate Glofitamab as Single Agent in Chinese Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
This study will evaluate the safety and efficacy of glofitamab as a single agent in Chinese patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have failed two or more lines of systemic therapy.
- Conditions
- DLBCL - Diffuse Large B Cell Lymphoma
- Being tested
- Glofitamab
- 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.
GlofitamabDrug
Glofitamab given in standard dosage
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Glofitamab Receives: Drug: Glofitamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression-free survival
Measured: 1 year
Secondary outcomes (5)
OS
overall survival
Measured: 2 year
CR rate
complete response
Measured: 6 weeks, 18 weeks, 36 weeks
ORR
overall response rate
Measured: 6 weeks, 18 weeks, 36 weeks
DOR
duration of response
Measured: 2 year
AE
Rate and type of adverse events (AEs) and serious adverse events (SAEs)
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DLBCL - Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- 3 Years
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06481826
- Sponsor's protocol ID
- Glofitamab-1
- Status last verified
- Mar 2026
- First submitted
- 12 Jun 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the study protocol, statistical analysis plan, informed consent form, clinical study report would be available upon email request in 3 years after the closure of the study
Publications
Dickinson MJ, Carlo-Stella C, Morschhauser F, Bachy E, Corradini P, Iacoboni G, Khan C, Wrobel T, Offner F, Trneny M, Wu SJ, Cartron G, Hertzberg M, Sureda A, Perez-Callejo D, Lundberg L, Relf J, Dixon M, Clark E, Humphrey K, Hutchings M. Glofitamab for Relapsed or Refractory Diffuse Large B-Cell Lymphoma. N Engl J Med. 2022 Dec 15;387(24):2220-2231. doi: 10.1056/NEJMoa2206913. Epub 2022 Dec 11.
PubMed 36507690Birtas Atesoglu E, Gulbas Z, Uzay A, Ozcan M, Ozkalemkas F, Dal MS, Kalyon H, Akay OM, Deveci B, Bekoz H, Sevindik OG, Toptas T, Yilmaz F, Koyun D, Alkis N, Alacacioglu I, Sonmez M, Yavasoglu I, Tombak A, Mehtap O, Kurnaz F, Yuce OK, Karakus V, Turgut M, Kurekci DD, Ayer M, Keklik M, Buyuktas D, Ozbalak M, Ferhanoglu B. Glofitamab in relapsed/refractory diffuse large B-cell lymphoma: Real-world data. Hematol Oncol. 2023 Oct;41(4):663-673. doi: 10.1002/hon.3174. Epub 2023 May 22.
PubMed 37211991Song YQ, Zhang HL, Huang HQ, Zhang QY, Jing HM, Wang C, Wu C, Li DH, Dai Y, Humphrey K, Zhu J. Glofitamab monotherapy induces high complete response rates and manageable safety in Chinese patients with heavily pretreated relapsed or refractory diffuse large B-cell lymphoma. Haematologica. 2024 Apr 1;109(4):1269-1273. doi: 10.3324/haematol.2023.283802. No abstract available.
PubMed 37855035
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate Glofitamab as Single Agent in Chinese Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT06481826
- Acronym / sponsor ID
- Glofitamab-1
- Conditions
- DLBCL - Diffuse Large B Cell Lymphoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 1 Jul 2024 (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 study will evaluate the safety and efficacy of glofitamab as a single agent in Chinese patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have failed two or more lines of systemic therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | – | Drug: GlofitamabGlofitamab |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Key inclusion criteria (3 listed)
- Histologically-confirmed DLBCL
- Participants must have relapsed or failed to respond to at least two lines of prior systemic therapy
- Participants must have measurable disease
Key exclusion criteria (5 listed)
- Pregnancy or breastfeeding
- Patient with known active infection, or reactivation of a latent infection
- Patient with active autoimmune disease or immune deficiency
- severe organ failure：LVEF<40%；DLCO<40%；eGFR<30ml/min；Bilirubin≥3ULN
- Patients who are dependent on the sponsor, the investigator or the trial site
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 |
|---|---|---|
| GlofitamabGlofitamab given in standard dosage | Drug | treatment group |
Primary outcome
PFS
Time frame: 1 year
Progression-free survival
5 secondary outcomes
OS
Time frame: 2 year
CR rate
Time frame: 6 weeks, 18 weeks, 36 weeks
ORR
Time frame: 6 weeks, 18 weeks, 36 weeks
DOR
Time frame: 2 year
AE
Time frame: 2 year
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 27 Mar 2026.
- Background: PubMed 36507690Dickinson MJ, Carlo-Stella C, Morschhauser F, Bachy E, Corradini P, Iacoboni G, Khan C, Wrobel T, Offner F, Trneny M, Wu SJ, Cartron G, Hertzberg M, Sureda A, Perez-Callejo D, Lundberg L, Relf J, Dixon M, Clark E, Humphrey K, Hutchings M. Glofitamab for Relapsed or Refractory Diffuse Large B-Cell Lymphoma. N Engl J Med. 2022 Dec 15;387(24):2220-2231. doi: 10.1056/NEJMoa2206913. Epub 2022 Dec 11.
- Background: PubMed 37211991Birtas Atesoglu E, Gulbas Z, Uzay A, Ozcan M, Ozkalemkas F, Dal MS, Kalyon H, Akay OM, Deveci B, Bekoz H, Sevindik OG, Toptas T, Yilmaz F, Koyun D, Alkis N, Alacacioglu I, Sonmez M, Yavasoglu I, Tombak A, Mehtap O, Kurnaz F, Yuce OK, Karakus V, Turgut M, Kurekci DD, Ayer M, Keklik M, Buyuktas D, Ozbalak M, Ferhanoglu B. Glofitamab in relapsed/refractory diffuse large B-cell lymphoma: Real-world data. Hematol Oncol. 2023 Oct;41(4):663-673. doi: 10.1002/hon.3174. Epub 2023 May 22.
- Background: PubMed 37855035Song YQ, Zhang HL, Huang HQ, Zhang QY, Jing HM, Wang C, Wu C, Li DH, Dai Y, Humphrey K, Zhu J. Glofitamab monotherapy induces high complete response rates and manageable safety in Chinese patients with heavily pretreated relapsed or refractory diffuse large B-cell lymphoma. Haematologica. 2024 Apr 1;109(4):1269-1273. doi: 10.3324/haematol.2023.283802. No abstract available.
- Individual participant dataSharing planned: Yes. the study protocol, statistical analysis plan, informed consent form, clinical study report would be available upon email request in 3 years after the closure of the study
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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 Peking Union Medical College 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 27 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 Jing Ruan (+8615201435860, 15201435860@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06481826, which also lists 3 linked publications.
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 27 Mar 2026.