Lymphoma, Non-HodgkinNCT06170216
Different Immunochemotherapies in Small B-cell Non-Hodgkin Lymphoma (iNHL)
An observational study of Lymphoma, Non-Hodgkin, run by Fudan University at 1 site in China.
Trial summary
Describe the application status of different immunochemotherapies in small B-cell non-Hodgkin lymphoma (iNHL), observe the therapeutic efficacy and safety of the treatment modalities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin
- What is being tested?
- immunochemotherapies
- How many people
- 206 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2023to 10 Jan 2026
- 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: Eligibale patients who ≥ 18 years old, Initial or first recurrent iNHL, with no contraindications to any medication in the treatment plan are enrolled. They will sign an informed consent form. Pregnant or lactating women were excluded. And patients who may not benefit from receiving immunochemotherapy evaluated by researchers are also excluded.
Who may be able to join
- Age ≥ 18 years old
- Initial or first recurrent iNHL confirmed by histopathology, including FL (1-3a), MZL, MCL;
- Sign an informed consent form;
- Researchers evaluate patients who can benefit from receiving immunochemotherapy.
Who cannot join
- There are contraindications to any medication in the treatment plan;
- Pregnant or lactating women or male and female participants of childbearing age did not take contraceptive measures during the trial period and within 30 days after the last medication;
- Researchers believe that patients who are not suitable for enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
About this study
Official title: A Single-center, Non-interventionary Clinical Study Evaluating the Efficacy and Safety of Different Immunochemotherapies in Small B-cell Non-Hodgkin Lymphoma (iNHL)
Describe the application status of different immunochemotherapies in small B-cell non-Hodgkin lymphoma (iNHL), observe the therapeutic efficacy and safety of the treatment modalities.
Read the detailed description
Evaluated the efficacy and safety of different immunochemotherapies in small B-cell non-Hodgkin lymphoma (iNHL)
- Conditions
- Lymphoma, Non-Hodgkin
- Being tested
- immunochemotherapies
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunochemotherapiesDrug
Observing different immunochemotherapies in small B-cell non-Hodgkin lymphoma (iNHL), which are chosen by investigators, such as RCHOP, BR, RCVP, etc.
| Study group | Role | What they receive |
|---|---|---|
| small B-cell non-Hodgkin lymphoma | Different immunochemotherapies in small B-cell non-Hodgkin lymphoma Receives: Drug: immunochemotherapies |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
the ratio of numbers of patients with complete response and partial response to all the participants receiving treatment
Measured: up to 6 months
Secondary outcomes (4)
2-year progression-free survival (PFS)
the period from the date of patients sign informed consent to the observed progression of the disease or the occurrence of death for any reason
Measured: From date of patients sign informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
2-year event-free survival (EFS)
the period from the date of patients sign informed consent to the observed event for any reason
Measured: From date of patients sign informed consent until the date of first documented event, progression or date of death from any cause, whichever came first, assessed up to 2 years
overall survival
time between the date of patients sign informed consent and the date of death or the date of last follow-up time
Measured: From date of patients sign informed consent until the date of death or the date of last follow-up time, whichever came first, assessed up to 2 years
Hematology and non hematology toxicity
number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: Throughout the treatment period，up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start10 Jan 2023
- Primary completion19 Dec 2023
- Study completion10 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- More trials run by Fudan 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yizhen Liu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170216
- Sponsor's protocol ID
- iNHL-01
- Status last verified
- Sep 2026
- First submitted
- 29 Nov 2023
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Non-interventionary Clinical Study Evaluating the Efficacy and Safety of Different Immunochemotherapies in Small B-cell Non-Hodgkin Lymphoma (iNHL)
- ClinicalTrials.gov ID
- NCT06170216
- Acronym / sponsor ID
- iNHL-01
- Conditions
- Lymphoma, Non-Hodgkin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 19 Dec 2023 (actual)
- Study completion
- 10 Jan 2026 (actual)
- First posted
- 14 Dec 2023 (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.
Describe the application status of different immunochemotherapies in small B-cell non-Hodgkin lymphoma (iNHL), observe the therapeutic efficacy and safety of the treatment modalities.
Detailed description
Evaluated the efficacy and safety of different immunochemotherapies in small B-cell non-Hodgkin lymphoma (iNHL)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| small B-cell non-Hodgkin lymphoma | – | Drug: immunochemotherapiesDifferent immunochemotherapies in small B-cell non-Hodgkin lymphoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligibale patients who ≥ 18 years old, Initial or first recurrent iNHL, with no contraindications to any medication in the treatment plan are enrolled. They will sign an informed consent form. Pregnant or lactating women were excluded. And patients who may not benefit from receiving immunochemotherapy evaluated by researchers are also excluded.
Key inclusion criteria (4 listed)
- Age ≥ 18 years old
- Initial or first recurrent iNHL confirmed by histopathology, including FL (1-3a), MZL, MCL;
- Sign an informed consent form;
- Researchers evaluate patients who can benefit from receiving immunochemotherapy.
Key exclusion criteria (3 listed)
- There are contraindications to any medication in the treatment plan;
- Pregnant or lactating women or male and female participants of childbearing age did not take contraceptive measures during the trial period and within 30 days after the last medication;
- Researchers believe that patients who are not suitable for enrollment.
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 |
|---|---|---|
| immunochemotherapiesObserving different immunochemotherapies in small B-cell non-Hodgkin lymphoma (iNHL), which are chosen by investigators, such as RCHOP, BR, RCVP, etc. | Drug | small B-cell non-Hodgkin lymphoma |
Primary outcome
ORR
Time frame: up to 6 months
the ratio of numbers of patients with complete response and partial response to all the participants receiving treatment
4 secondary outcomes
2-year progression-free survival (PFS)
Time frame: From date of patients sign informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
2-year event-free survival (EFS)
Time frame: From date of patients sign informed consent until the date of first documented event, progression or date of death from any cause, whichever came first, assessed up to 2 years
overall survival
Time frame: From date of patients sign informed consent until the date of death or the date of last follow-up time, whichever came first, assessed up to 2 years
Hematology and non hematology toxicity
Time frame: Throughout the treatment period，up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lymphoma, Non-Hodgkin, run by Fudan 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 4 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: finished, as of the sponsor's last update on 3 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 3 Sep 2026.