Lymphoma, Non-HodgkinNCT06190457
Safety and Efficacy of Intrathecal Rituximab in 16 Children of Stage Ⅲ、ⅣNon-Hodgkin Lymphoma
An observational study of Lymphoma, Non-Hodgkin and Child, Only, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Trial summary
Objective: This study demonstrated that the efficacy and safety of intrathecal(IT) rituximab in the treatment of stage Ⅲ and Ⅳ non-Hodgkin lymphoma(NHL) in children. Methods: We reported 16 children were histologically diagnosed as stage Ⅲ and Ⅳ NHL from September 2015 to December 2020 who received IT rituximab in… Read more about this study
- Who is it for?
- Ages 1 day to 14 years
- Conditions the study is for
- Lymphoma, Non-Hodgkin, Child, Only
- What is being tested?
- intrathecal rituximab
- Type of treatment
- Injection or infusion
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2015to 30 Aug 2022
- 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 1 day to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: All children were diagnosed according to WHO lymphoma typing criteria by pathomorphological classification and immunophenotyping of tissues or bone marrow
Who may be able to join
- Clinical diagnosis of B lymphocyte NHL
- Age≤ 18 years old
- Normal heart and kidney function
Who cannot join
- Heart, liver and kidney diseases
- Allergic to rituximab
About this study
Objective: This study demonstrated that the efficacy and safety of intrathecal(IT) rituximab in the treatment of stage Ⅲ and Ⅳ non-Hodgkin lymphoma(NHL) in children.
Methods: We reported 16 children were histologically diagnosed as stage Ⅲ and Ⅳ NHL from September 2015 to December 2020 who received IT rituximab in Pediatric Oncology of Sun Yat-Sen Memorial Hospital were restrospectively analyzed. The clinical manifestations, central nervous system involvement,treatment plan and prognosis of patients were analyzed....
ALL patients were pathologically positive for CD20 received the modified NHL-BFM 95, while IT rituximab was arranged the day before the chemotherapy, which was simultaneously used with the intravenous infusion of rituximab. The median time of doses received by each patient was 5 times, every three weeks, with the IT dose of 10 mg,15 mg, and 20 mg in increments.
Read the detailed description
Malignant lymphoma is one of the most common malignancies in children, with approximately 60 percent of cases being B-cell, non-hodgkin lymphoma (NHL) . NHL in children progresses rapidly, prone to bone marrow and central nervous system (CNS) involvement , CNS-infested NHL has a poor prognosis regardless of primary or secondary , high-intensity chemotherapy, intravenous rituximab (RTX), radiotherapy, and hematopoietic stem cell transplantation, HSCT) has limited efficacy in the treatment of these children because only a small percentage of drugs/antibodies can penetrate the blood-brain barrier . Only a limited number of intrathecal agents, primarily methotrexate, steroids, and cytarabine, have been identified that have demonstrated safety in the use of CNS-violated NHL but have not improved long-term survival in these children . Therefore, whether safe and effective intrathecal drugs can be found is the focus of the treatment and prevention of CNS-infused NHL.
Most B-cell NHL tumors express CD20 antigen in tumor tissues , RTX is a chimeric monoclonal antibody specific to B-cell CD20 antigen, and a large number of studies have confirmed that intravenous infusion of RTX has a good effect on adult and pediatric B-cell NHL . However, intravenous RTX concentrations in cerebrospinal fluid are low, ranging from 0.1 to 4.4 percent of the blood concentration, and repeated intravenous use does not increase its drug concentration in the cerebrospinal fluid . Recent small clinical studies have shown that intrathecal RTX injection is safe in adult lymphoma patients , but there are no domestic cases of intrathecal RTX use in childhood lymphoma. In this paper, 16 clinical cases of intrathecal RTX injection of stage III and IV. B-cell NHL were analyzed to explore the safety and efficacy of RTX intrathecal therapy.
- Conditions
- Lymphoma, Non-Hodgkin, Child, Only
- Being tested
- intrathecal rituximab
- 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.
intrathecal rituximabOther
All children were treated with a modified NHL-BFM95 regimen for children NHL with the addition of rituximab, both intravenous and intrathecal, and rituximab intrathecal infusion is scheduled to be used simultaneously with rituximab intravenous drip. rituximab intrathecal doses are 10 mg, 15 mg, and 20 mg in increments every 3 weeks. rituximab intrathecal injection does not use methotrexate or/and cytarabine intrathecaline chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | From May 2015 to December 2020, 16 children with NHL who were diagnosed in the Department of Pediatric Oncology of Sun Yat-sen Memorial Hospital of Sun Yat-sen University agreed to receive RTX intrathecal therapy and signed an informed consent form. Among them, there were 13 males and 3 females, with a male-to-female ratio of 4.33:1.00, an age of 5.1-13.1 years, and an average age of onset of 8.5 years.
1.2 Diagnosis All children are diagnosed according to WHO lymphoma typing criteria by pathomorphological classification and immunotyping of tissue or bone marrow .
Exclusion Criteria Patients with severe organic diseases such as heart, liver and kidney, allergic to rituximab. Receives: Other: intrathecal rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year disease-free survival rate
DFS is the time from grouping to evidence of disease recurrence
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start30 Sep 2015
- Primary completion30 Dec 2020
- Study completion30 Aug 2022
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 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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
- Retrospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yang Li, Study chair, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06190457
- Sponsor's protocol ID
- SYSEC- KY- KS-2022-141
- Status last verified
- Dec 2023
- First submitted
- 12 Jun 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This data can be requested by sending an email to the author.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Intrathecal Rituximab in 16 Children of Stage Ⅲ、ⅣNon-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT06190457
- Acronym / sponsor ID
- SYSEC- KY- KS-2022-141
- Conditions
- Lymphoma, Non-Hodgkin, Child, Only
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 30 Sep 2015 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 5 Jan 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.
Objective: This study demonstrated that the efficacy and safety of intrathecal(IT) rituximab in the treatment of stage Ⅲ and Ⅳ non-Hodgkin lymphoma(NHL) in children.
Methods: We reported 16 children were histologically diagnosed as stage Ⅲ and Ⅳ NHL from September 2015 to December 2020 who received IT rituximab in Pediatric Oncology of Sun Yat-Sen Memorial Hospital were restrospectively analyzed. The clinical manifestations, central nervous system involvement,treatment plan and prognosis of patients were analyzed....
ALL patients were pathologically positive for CD20 received the modified NHL-BFM 95, while IT rituximab was arranged the day before the chemotherapy, which was simultaneously used with the intravenous infusion of rituximab. The median time of doses received by each patient was 5 times, every three weeks, with the IT dose of 10 mg,15 mg, and 20 mg in increments.
Detailed description
Malignant lymphoma is one of the most common malignancies in children, with approximately 60 percent of cases being B-cell, non-hodgkin lymphoma (NHL) . NHL in children progresses rapidly, prone to bone marrow and central nervous system (CNS) involvement , CNS-infested NHL has a poor prognosis regardless of primary or secondary , high-intensity chemotherapy, intravenous rituximab (RTX), radiotherapy, and hematopoietic stem cell transplantation, HSCT) has limited efficacy in the treatment of these children because only a small percentage of drugs/antibodies can penetrate the blood-brain barrier . Only a limited number of intrathecal agents, primarily methotrexate, steroids, and cytarabine, have been identified that have demonstrated safety in the use of CNS-violated NHL but have not improved long-term survival in these children . Therefore, whether safe and effective intrathecal drugs can be found is the focus of the treatment and prevention of CNS-infused NHL.
Most B-cell NHL tumors express CD20 antigen in tumor tissues , RTX is a chimeric monoclonal antibody specific to B-cell CD20 antigen, and a large number of studies have confirmed that intravenous infusion of RTX has a good effect on adult and pediatric B-cell NHL . However, intravenous RTX concentrations in cerebrospinal fluid are low, ranging from 0.1 to 4.4 percent of the blood concentration, and repeated intravenous use does not increase its drug concentration in the cerebrospinal fluid . Recent small clinical studies have shown that intrathecal RTX injection is safe in adult lymphoma patients , but there are no domestic cases of intrathecal RTX use in childhood lymphoma. In this paper, 16 clinical cases of intrathecal RTX injection of stage III and IV. B-cell NHL were analyzed to explore the safety and efficacy of RTX intrathecal therapy.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Other: intrathecal rituximabFrom May 2015 to December 2020, 16 children with NHL who were diagnosed in the Department of Pediatric Oncology of Sun Yat-sen Memorial Hospital of Sun Yat-sen University agreed to receive RTX intrathecal therapy and signed an informed consent form. Among them, there were 13 males and 3 females, with a male-to-female ratio of 4.33:1.00, an age of 5.1-13.1 years, and an average age of onset of 8.5 years. 1.2 Diagnosis All children are diagnosed according to WHO lymphoma typing criteria by pathomorphological classification and immunotyping of tissue or bone marrow . Exclusion Criteria Patients with severe organic diseases such as heart, liver and kidney, allergic to rituximab. |
Who may qualify
- Ages
- 1 day to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All children were diagnosed according to WHO lymphoma typing criteria by pathomorphological classification and immunophenotyping of tissues or bone marrow
Key inclusion criteria (3 listed)
- Clinical diagnosis of B lymphocyte NHL
- Age≤ 18 years old
- Normal heart and kidney function
Key exclusion criteria (2 listed)
- Heart, liver and kidney diseases
- Allergic to rituximab
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 |
|---|---|---|
| intrathecal rituximabAll children were treated with a modified NHL-BFM95 regimen for children NHL with the addition of rituximab, both intravenous and intrathecal, and rituximab intrathecal infusion is scheduled to be used simultaneously with rituximab intravenous drip. rituximab intrathecal doses are 10 mg, 15 mg, and 20 mg in increments every 3 weeks. rituximab intrathecal injection does not use methotrexate or/and cytarabine intrathecaline chemotherapy. | Other | Experimental group |
Primary outcome
3-year disease-free survival rate
Time frame: 36 months
DFS is the time from grouping to evidence of disease recurrence
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 5 Jan 2024.
- Individual participant dataSharing planned: No. This data can be requested by sending an email to the author.
Related trials for Lymphoma, Non-Hodgkin
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingObservational study
Multi-omics Profiling of Relapsed Extranodal Natural Killer (NK)/T-cell Lymphoma
Extranodal NK/T-cell Lymphoma, Nasal Type
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.
Yang Li study chair
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, Non-Hodgkin and Child, Only, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
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: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
3-year disease-free survival rate (time frame: 36 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 5 Jan 2024.