Diffuse Large B-Cell LymphomaNCT06755775
PET Imaging Targeting Granzyme B Predicts Immunotherapy Efficacy in Diffuse Large B-cell Lymphoma
An observational study of Diffuse Large B-Cell Lymphoma, run by Ruijin Hospital at 1 site in China.
Trial summary
This study aims to investigate the predictive value of PET imaging targeting granzyme B on the outcome of patients with diffuse large B lymphoma receiving immunotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 23 Jul 2024to 23 Jul 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese patient with pathologically confirmed diffuse large B-cell lymphoma
Who may be able to join
- Pathologic diagnosis of DLBCL
- Patient's general condition is good and survival is expected to be greater than six months
- Signed and dated informed consent form
Who cannot join
- Combined with other malignant tumors
- Patients with serious medical conditions who, in the opinion of the investigator, are not suitable for participation in this clinical study
- Pregnant women and women at risk of pregnancy, breastfeeding women
- poor compliant
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
Ruijin Hospital Affiliated to Shanghai Jiao Tong University Medical School
Shanghai
Biao Li, 13661777388, lb10363@rjh.com.cn
About this study
This study aims to investigate the predictive value of PET imaging targeting granzyme B on the outcome of patients with diffuse large B lymphoma receiving immunotherapy.
Read the detailed description
The investigators will number all participants, create a medical record file, and record their basic information (gender, age) as well as contact information and medical history information. All participants will undergo 68Ga-grazytracer PET at baseline and after one course of immunotherapy (CAR-T, Glofitamab or iR2 ).
- Conditions
- Diffuse Large B-Cell Lymphoma
- Keywords
- PET/CT, Granzyme B, immunotherapy
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lipodystrophy, Congenital Generalized
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 |
|---|---|---|
| patients diagnosed with DLBCL who will receive immunotherapy (CAR-T, glofitamab, iR2) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The value of PET imaging targeting granzyme B in predicting the efficacy of immunotherapy for diffuse large B-cell lymphoma
The value of PET imaging targeting granzyme B in predicting the efficacy of immunotherapy for diffuse large B-cell lymphoma
Measured: Baseline and 2 weeks after treatment
Standardized uptake value (SUV)
SUV of 68Ga-grazytracer uptake on PET/CT images for tumor lesions
Measured: Baseline and 2 weeks after treatment
Secondary outcomes (2)
Progress free suivival
Progress free suivival
Measured: 3 years
Overall survival
Overall survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start23 Jul 2024
- Primary completion23 Jul 2029 (estimated)
- Study completion23 Jul 2029 (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 LymphomaStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LI BIAO, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755775
- Sponsor's protocol ID
- RuijinH 2024-254
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Imaging Targeting Granzyme B Predicts Immunotherapy Efficacy in Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT06755775
- Acronym / sponsor ID
- RuijinH 2024-254
- Conditions
- Diffuse Large B-Cell Lymphoma
- Keywords
- PET/CT, Granzyme B, immunotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 23 Jul 2024 (actual)
- Primary completion
- 23 Jul 2029 (estimated)
- Study completion
- 23 Jul 2029 (estimated)
- First posted
- 1 Jan 2025 (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 aims to investigate the predictive value of PET imaging targeting granzyme B on the outcome of patients with diffuse large B lymphoma receiving immunotherapy.
Detailed description
The investigators will number all participants, create a medical record file, and record their basic information (gender, age) as well as contact information and medical history information. All participants will undergo 68Ga-grazytracer PET at baseline and after one course of immunotherapy (CAR-T, Glofitamab or iR2 ).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients diagnosed with DLBCL who will receive immunotherapy (CAR-T, glofitamab, iR2) | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese patient with pathologically confirmed diffuse large B-cell lymphoma
Key inclusion criteria (3 listed)
- Pathologic diagnosis of DLBCL
- Patient's general condition is good and survival is expected to be greater than six months
- Signed and dated informed consent form
Key exclusion criteria (4 listed)
- Combined with other malignant tumors
- Patients with serious medical conditions who, in the opinion of the investigator, are not suitable for participation in this clinical study
- Pregnant women and women at risk of pregnancy, breastfeeding women
- poor compliant
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
The value of PET imaging targeting granzyme B in predicting the efficacy of immunotherapy for diffuse large B-cell lymphoma
Time frame: Baseline and 2 weeks after treatment
The value of PET imaging targeting granzyme B in predicting the efficacy of immunotherapy for diffuse large B-cell lymphoma
Standardized uptake value (SUV)
Time frame: Baseline and 2 weeks after treatment
SUV of 68Ga-grazytracer uptake on PET/CT images for tumor lesions
2 secondary outcomes
Progress free suivival
Time frame: 3 years
Overall survival
Time frame: 3 years
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 1 Jan 2025.
- 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, 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 3 inclusion and 4 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 1 Jan 2025. 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 Xinyi Zhu (19121913585, zxy16zz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The value of PET imaging targeting granzyme B in predicting the efficacy of immunotherapy for diffuse large B-cell lymphoma (time frame: Baseline and 2 weeks after treatment). The study lists 2 primary outcomes in all. 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 1 Jan 2025.