B-cell Non-Hodgkin LymphomaGLOFTSTNCT06497452
A Study of Efficacy and Safety of Glofitamab in Combination With Salvage Therapy in a Real-world Setting in Chinese Adult Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma.
An observational study of B-cell Non-Hodgkin Lymphoma, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
The purpose of this study is to assess the efficacy and safety in the real-world settings of glofitamab in combination with salvage therapy among Chinese adult patients with relapsed or refractory B-cell non-hodgkin lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-cell Non-Hodgkin Lymphoma
- What is being tested?
- Glofitamab
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 1 Jun 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 three months prior to enrollment and after the indication approval will be observed in this study.
Who may be able to join
- Be diagnosed as B-NHL
- Relapse or refractory to previous treatment
- Participants who will be treated with glofitamab
Who cannot join
- Participant who currently participates in or with plan to participate in any interventional clinical trial
- 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.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
Haiwen Huang, M.D., 0512-80668050, huanghaiwen@suda.edu.cn
About this study
Official title: A Prospective, Observational Study to Explore the Efficacy and Safety of Salvage Therapy With Glofitamab in a Real-world Setting in Chinese Adult Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma.
The purpose of this study is to assess the efficacy and safety in the real-world settings of glofitamab in combination with salvage therapy among Chinese adult patients with relapsed or refractory B-cell non-hodgkin lymphoma.
- Conditions
- B-cell Non-Hodgkin Lymphoma
- Being tested
- Glofitamab
- Medical subject headings
- Lymphoma, B-Cell
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
| Study group | Role | What they receive |
|---|---|---|
| Observational Cohort | Not described Receives: Drug: Glofitamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Complete Response Rate (bCRR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
Measured: Baseline up to EOT (approximately 9 months)
Secondary outcomes (7)
Best Overall Response Rate (bORR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
Measured: Baseline up to EOT (approximately 9 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 24 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 24 months)
PFS Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
Measured: Baseline up to end of study (approximately 24 months)
Event Free Survival (EFS) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
Measured: From the start of glofitamab treatment to any treatment failure including disease progression, relapse, initiation of new antilymphoma therapy (NALT), or death from any cause, which occurs first (up to approximately 24 months)
Overall Survival (OS)
Measured: From the start of glofitamab treatment until the date of death from any cause (up to approximately 24 months)
Time to Next Treatment (TTNT)
Measured: From the start of glofitamab treatment to the initiation of next-line treatment (up to approximately 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start1 Jun 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe 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
- 50 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497452
- Sponsor's protocol ID
- GLOFTST
- Acronym
- GLOFTST
- Status last verified
- Jun 2024
- First submitted
- 5 Jul 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational Study to Explore the Efficacy and Safety of Salvage Therapy With Glofitamab in a Real-world Setting in Chinese Adult Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma.
- ClinicalTrials.gov ID
- NCT06497452
- Acronym / sponsor ID
- GLOFTST / GLOFTST
- Conditions
- B-cell Non-Hodgkin Lymphoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 11 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.
The purpose of this study is to assess the efficacy and safety in the real-world settings of glofitamab in combination with salvage therapy among Chinese adult patients with relapsed or refractory B-cell non-hodgkin lymphoma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Cohort | – | Drug: Glofitamab |
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 three months prior to enrollment and after the indication approval will be observed in this study.
Key inclusion criteria (3 listed)
- Be diagnosed as B-NHL
- Relapse or refractory to previous treatment
- Participants who will be treated with glofitamab
Key exclusion criteria (2 listed)
- Participant who currently participates in or with plan to participate in any interventional clinical trial
- 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 | Observational Cohort |
Primary outcome
Best Complete Response Rate (bCRR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
Time frame: Baseline up to EOT (approximately 9 months)
7 secondary outcomes
Best Overall Response Rate (bORR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
Time frame: Baseline up to EOT (approximately 9 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 24 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 24 months)
PFS Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
Time frame: Baseline up to end of study (approximately 24 months)
Event Free Survival (EFS) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma
Time frame: From the start of glofitamab treatment to any treatment failure including disease progression, relapse, initiation of new antilymphoma therapy (NALT), or death from any cause, which occurs first (up to approximately 24 months)
Overall Survival (OS)
Time frame: From the start of glofitamab treatment until the date of death from any cause (up to approximately 24 months)
Time to Next Treatment (TTNT)
Time frame: From the start of glofitamab treatment to the initiation of next-line treatment (up to approximately 24 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
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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.
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 B-cell Non-Hodgkin Lymphoma, run by The First Affiliated Hospital of Soochow University 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 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: status not confirmed, as of the sponsor's last update on 11 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haiwen Huang (0512-80668050, huanghaiwen@suda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Complete Response Rate (bCRR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma (time frame: Baseline up to EOT (approximately 9 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 11 Jul 2024; AzTrials last refreshed its copy on 8 Nov 2026.