Lymphoma, Non-HodgkinNCT07721194
Primary Bone Mature B-Cell NHL in Children
An observational study of Lymphoma, Non-Hodgkin, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Background:Primary bone mature B-cell lymphomas (PB-BCL) are rare in children and adolescents. Current data on their clinical presentation, management, and outcomes remain limited. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Lymphoma, Non-Hodgkin
- What is being tested?
- Descriptive data
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 28 Mar 2023to 13 May 2025
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with non Hodgkin lymphoma originating from an "other" extranodal site treated between 1998 and 2022 enrolled in or treated according to the FAB LMB96, LMB 2001, or Inter-B-NHL Ritux 2010 protocols
Who may be able to join
- Age <21 years at diagnosis.
- Single or multifocal bone lesions, with or without regional lymph node involvement
- Diagnosis of B-cell non-Hodgkin lymphoma had to be histologically confirmed
- Enrolled in or treated according to the FAB LMB 96, LMB 2001, or Inter-B-NHL Ritux 2010 studies between 1998 and 2022
Who cannot join
- Disease extension to organs other than the regional lymph nodes or bones
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Primary Bone Mature B-cell Non-Hodgkin Lymphomas in Children and Adolescents A French Society of Pediatric Oncology (SFCE) Study
Background:Primary bone mature B-cell lymphomas (PB-BCL) are rare in children and adolescents. Current data on their clinical presentation, management, and outcomes remain limited. The aim of the study was to describe the clinical and radiological characteristics and outcomes of pediatric patients with PB-BCL using data from a multicenter French cohort.Procedure: The team retrospectively analysed data from paediatric patients diagnosed with PB-BCL between 1998 and 2022 and treated according to national protocols (FAB LMB 96, LMB 2001, Inter-B-NHL Ritux 2010). Clinical, imaging, pathological, and therapeutic data were collected. Event-free survival (EFS) and overall survival (OS) were estimated using the Kaplan-Meier method. Results: The cohort included 21 patients, with a male predominance (62%) and a median age at diagnosis of 13 years (3-19). Diffuse large B-cell lymphoma accounted for 66.6% of cases, and Burkitt lymphoma for 28.6%. Lesions were predominantly located in the lower limbs. Multifocal bone involvement was observed in 38.1% of patients and 38.1% were classified as stage III at diagnosis. All patients have been treated with FAB/LMB chemotherapy, with 5 patients receiving Rituximab. After a median follow-up of 3.3 years (0.15 - 19.6), 5-year OS and EFS were 94.5% and 89.7%, respectively. Evaluation of remission and follow-up strategies varied between centers. Conclusions : PB-BCL in children is associated with an excellent prognosis under current treatment protocols, even in advanced-stage disease. However, standardization of remission assessment and post-treatment surveillance remains necessary. Molecular profiling may help improve the understanding of this rare entity.
- Conditions
- Lymphoma, Non-Hodgkin
- Being tested
- Descriptive data
- 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.
Descriptive dataOther
Clinical, imaging, pathological, and therapeutic data were collected
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival (OS)
Overall Survival (OS) is defined as the time from treatment initiation until death from any cause. Patients who are still alive at the time of the analysis or who are lost to follow-up are censored at the date they were last known to be alive. Overall survival is estimated using the Kaplan-Meier method,
Measured: 5 years
Secondary outcomes (1)
Event-free survival (EFS)
Event-Free Survival (EFS) is defined as the time from treatment initiation until the occurrence of the first predefined event. Events may include disease progression, relapse or the occurrence of a second malignancy. Patients who do not experience an event by the time of the analysis or who are lost to follow-up are censored at the date of their last disease assessment or last known event-free status. Event-free survival is estimated using the Kaplan-Meier method,
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start28 Mar 2023
- Primary completion13 May 2025
- Study completion13 May 2025
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 Centre Hospitalier Universitaire de NiceThe 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
- Retrospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07721194
- Sponsor's protocol ID
- 26Hemato-Onco-Pediat01
- Status last verified
- Jun 2026
- First submitted
- 3 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Bone Mature B-cell Non-Hodgkin Lymphomas in Children and Adolescents A French Society of Pediatric Oncology (SFCE) Study
- ClinicalTrials.gov ID
- NCT07721194
- Acronym / sponsor ID
- 26Hemato-Onco-Pediat01
- Conditions
- Lymphoma, Non-Hodgkin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 13 May 2025 (actual)
- Study completion
- 13 May 2025 (actual)
- First posted
- 22 Jul 2026 (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.
Background:Primary bone mature B-cell lymphomas (PB-BCL) are rare in children and adolescents. Current data on their clinical presentation, management, and outcomes remain limited. The aim of the study was to describe the clinical and radiological characteristics and outcomes of pediatric patients with PB-BCL using data from a multicenter French cohort.Procedure: The team retrospectively analysed data from paediatric patients diagnosed with PB-BCL between 1998 and 2022 and treated according to national protocols (FAB LMB 96, LMB 2001, Inter-B-NHL Ritux 2010). Clinical, imaging, pathological, and therapeutic data were collected. Event-free survival (EFS) and overall survival (OS) were estimated using the Kaplan-Meier method. Results: The cohort included 21 patients, with a male predominance (62%) and a median age at diagnosis of 13 years (3-19). Diffuse large B-cell lymphoma accounted for 66.6% of cases, and Burkitt lymphoma for 28.6%. Lesions were predominantly located in the lower limbs. Multifocal bone involvement was observed in 38.1% of patients and 38.1% were classified as stage III at diagnosis. All patients have been treated with FAB/LMB chemotherapy, with 5 patients receiving Rituximab. After a median follow-up of 3.3 years (0.15 - 19.6), 5-year OS and EFS were 94.5% and 89.7%, respectively. Evaluation of remission and follow-up strategies varied between centers. Conclusions : PB-BCL in children is associated with an excellent prognosis under current treatment protocols, even in advanced-stage disease. However, standardization of remission assessment and post-treatment surveillance remains necessary. Molecular profiling may help improve the understanding of this rare entity.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with non Hodgkin lymphoma originating from an "other" extranodal site treated between 1998 and 2022 enrolled in or treated according to the FAB LMB96, LMB 2001, or Inter-B-NHL Ritux 2010 protocols
Key inclusion criteria (4 listed)
- Age <21 years at diagnosis.
- Single or multifocal bone lesions, with or without regional lymph node involvement
- Diagnosis of B-cell non-Hodgkin lymphoma had to be histologically confirmed
- Enrolled in or treated according to the FAB LMB 96, LMB 2001, or Inter-B-NHL Ritux 2010 studies between 1998 and 2022
Key exclusion criteria (1 listed)
- Disease extension to organs other than the regional lymph nodes or bones
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 |
|---|---|---|
| Descriptive dataClinical, imaging, pathological, and therapeutic data were collected | Other | – |
Primary outcome
overall survival (OS)
Time frame: 5 years
Overall Survival (OS) is defined as the time from treatment initiation until death from any cause. Patients who are still alive at the time of the analysis or who are lost to follow-up are censored at the date they were last known to be alive. Overall survival is estimated using the Kaplan-Meier method,
1 secondary outcome
Event-free survival (EFS)
Time frame: 5 years
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 22 Jul 2026.
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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 Centre Hospitalier Universitaire de Nice at 1 site in France.
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 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: finished, as of the sponsor's last update on 22 Jul 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 France. 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?
overall survival (OS) (time frame: 5 years). 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 22 Jul 2026.