Diffuse Large B Cell Lymphoma (DLBCL)NCT06656234
The Effectiveness and Safety of Glofitamab in Real-World Clinical Practice Among Chinese Adult Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma: A Prospective, Observational, Multicenter Study
An observational study of Diffuse Large B Cell Lymphoma (DLBCL), run by Ruijin Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the the efficacy and safety in the real-world settings of glofitamab among Chinese R/R DLBCL participants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B Cell Lymphoma (DLBCL)
- What is being tested?
- Glofitamab and Obinutuzumab
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2024to 15 Sep 2028
- 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: Participants who will be treated with glofitamab (known as being recommended and having the intention to be treated with glofitamab at the time of signing informed consent) or have initiated glofitamab treatment within 6 months prior to enrollment and after the indication approval will be observed in this study.
Who may be able to join
- Be diagnosed as R/R DLBCL
- Participants who will be treated with glofitamab (known as being recommended and having the intention to be treated with glofitamab at the time of signing informed consent) or have initiated glofitamab treatment within 6 months prior to enrollment and after the indication approval will be observed in this study.
Who cannot join
- Any other reason that, in the investigator's opinion, makes the participant unsuitable to participate in this study.
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
Ruijin Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Weili Zhao, 008602164370045, zwl_trial@163.com
About this study
The purpose of this study is to evaluate the the efficacy and safety in the real-world settings of glofitamab among Chinese R/R DLBCL participants.
- Conditions
- Diffuse Large B Cell Lymphoma (DLBCL)
- Being tested
- Glofitamab, Obinutuzumab
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlofitamabDrug
Glofitamab will be administered at the discretion of the physician per local clinical practice and local labeling.
ObinutuzumabDrug
Obinutuzumab pre-treatment is given intravenously at a dose of 1g on Cycle 1 Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Participants with relapsed or refractory (R/R) DLBCL who have started receiving glofitamab at physician's discretion in accordance with local clinical practice and/or labeling will be observed for safety and efficacy until death, withdrawal of consent, loss to follow-up or end of study whichever occurs first (up to approximately 4 years). Receives: Drug: Glofitamab; Drug: Obinutuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
Measured: Baseline up to end of study (EOS) (approximately 48 months)
Secondary outcomes (6)
Complete Response Rate (CRR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
Measured: Baseline up to EOS (approximately 48 months)
Overall Response Rate (ORR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
Measured: Baseline up to EOS (approximately 48 months)
Duration of Response (DoR)
Measured: From the date of the first occurrence of a documented CR or partial response (PR) to the date of progression, relapse, or death from any cause, whichever occurs first (up to approximately 48 months)
Duration of Complete Response (DoCR)
Measured: From the date of the first occurrence of a documented CR to the date of progression, relapse, or death from any cause, whichever occurs first (up to approximately 48 months)
Time to Next Treatment (TTNT)
Measured: From the start of glofitamab treatment to the initiation of next-line treatment (up to approximately 48 months)
Overall Survival (OS)
Measured: From the start of glofitamab treatment until the date of death from any cause (up to approximately 48 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start30 Oct 2024 (estimated)
- Primary completion15 Sep 2027 (estimated)
- Study completion15 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell Lymphoma (DLBCL)Studies of the same condition, open and under way.
- More trials run by Ruijin 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06656234
- Sponsor's protocol ID
- GloReal
- Status last verified
- Oct 2024
- First submitted
- 23 Oct 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Safety of Glofitamab in Real-World Clinical Practice Among Chinese Adult Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma: A Prospective, Observational, Multicenter Study
- ClinicalTrials.gov ID
- NCT06656234
- Acronym / sponsor ID
- GloReal
- Conditions
- Diffuse Large B Cell Lymphoma (DLBCL)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 30 Oct 2024 (estimated)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 15 Sep 2028 (estimated)
- First posted
- 24 Oct 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.
The purpose of this study is to evaluate the the efficacy and safety in the real-world settings of glofitamab among Chinese R/R DLBCL participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: Glofitamab, Drug: ObinutuzumabParticipants with relapsed or refractory (R/R) DLBCL who have started receiving glofitamab at physician's discretion in accordance with local clinical practice and/or labeling will be observed for safety and efficacy until death, withdrawal of consent, loss to follow-up or end of study whichever occurs first (up to approximately 4 years). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who will be treated with glofitamab (known as being recommended and having the intention to be treated with glofitamab at the time of signing informed consent) or have initiated glofitamab treatment within 6 months prior to enrollment and after the indication approval will be observed in this study.
Key inclusion criteria (2 listed)
- Be diagnosed as R/R DLBCL
- Participants who will be treated with glofitamab (known as being recommended and having the intention to be treated with glofitamab at the time of signing informed consent) or have initiated glofitamab treatment within 6 months prior to enrollment and after the indication approval will be observed in this study.
Key exclusion criteria (1 listed)
- Any other reason that, in the investigator's opinion, makes the participant unsuitable to participate in this study.
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 will be administered at the discretion of the physician per local clinical practice and local labeling. | Drug | Cohort 1 |
| ObinutuzumabObinutuzumab pre-treatment is given intravenously at a dose of 1g on Cycle 1 Day 1. | Drug | Cohort 1 |
Primary outcome
Progression free survival (PFS) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
Time frame: Baseline up to end of study (EOS) (approximately 48 months)
6 secondary outcomes
Complete Response Rate (CRR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
Time frame: Baseline up to EOS (approximately 48 months)
Overall Response Rate (ORR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
Time frame: Baseline up to EOS (approximately 48 months)
Duration of Response (DoR)
Time frame: From the date of the first occurrence of a documented CR or partial response (PR) to the date of progression, relapse, or death from any cause, whichever occurs first (up to approximately 48 months)
Duration of Complete Response (DoCR)
Time frame: From the date of the first occurrence of a documented CR to the date of progression, relapse, or death from any cause, whichever occurs first (up to approximately 48 months)
Time to Next Treatment (TTNT)
Time frame: From the start of glofitamab treatment to the initiation of next-line treatment (up to approximately 48 months)
Overall Survival (OS)
Time frame: From the start of glofitamab treatment until the date of death from any cause (up to approximately 48 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 24 Oct 2024.
- 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 Diffuse Large B Cell Lymphoma (DLBCL), run by Ruijin 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 2 inclusion and 1 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 24 Oct 2024. 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 Weili Zhao (008602164370045, zwl_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma (time frame: Baseline up to end of study (EOS) (approximately 48 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 24 Oct 2024.