RituximabNCT03958916
Prospective Multicenters Clinical Cohort Study of Stratified Treatment of Chinese Children With BL/DLBCL
An observational study of Rituximab and Lymphoma, Non-Hodgkin, run by Sun Yat-sen University at 1 site in China.
Trial summary
The trial SCCCG-BL/DLBCL-2017 is a collaborative prospective, multicenters, non-randomized, observational, cohort clinical study with participating centers of the South China Children's Cancer Group-Non-Hodgkin lymphoma group(SCCCG-NHL). Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Rituximab, Lymphoma, Non-Hodgkin, Pediatric Cancer
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 5 May 2017to 5 May 2025
- How long will I take part?
- 5 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 1 year to 18 years
- All sexes
- Child, Adult
Study population: Burkitt lymphoma/diffuse large B-cell lymphoma patients，age at diagnosis < 18 years.
Who may be able to join
- Age < 18 years old
- Pathologically confirmed Burkitt lymphoma or diffuse large B-cell lymphoma
- Newly diagnosed patients
- Informed consent of guardian of children patients
Who cannot join
- Pathological components with follicular lymphoma
- Immunodeficiency Second neoplasm
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Sun Xiaofei, Master, 13600099837 ext. 086, sunxf@sysucc.org.cn
About this study
Official title: Prospective Multicenters Clinical Cohort Study on Efficacy and Safety of Stratified Treatment for Chinese Children With Burkitt Lymphoma/Diffuse Large B-cell Lymphoma
The trial SCCCG-BL/DLBCL-2017 is a collaborative prospective, multicenters, non-randomized, observational, cohort clinical study with participating centers of the South China Children's Cancer Group-Non-Hodgkin lymphoma group(SCCCG-NHL). The aim of the study is to evaluate efficacy and safety of stratified treatment based on risk factors of childhood and adolescents Burkitt lymphoma(BL)/diffuse large B-cell lymphoma(DLBCL) patients in china.
Read the detailed description
Research purposes:
- To investigate the efficacy and safety of SCCCG-BL/DLBCL-2017 in children with BL and DLBCL.
- To investigate the effect of rituximab combined with chemotherapy on the survival rate of children with high-risk BL/DLBCL.
- To investigate the effect of rituximab on immune function in children with high-risk BL/DLBCL.
- To explore the correlation between MRD detection and the efficacy and survival of children with BL/DLBCL.
- To explore the role of PET/CT in evaluating residual lesions in children after BL/DLBCL treatment.
- Conditions
- Rituximab, Lymphoma, Non-Hodgkin, Pediatric Cancer
- Medical subject headings
- Lymphoma, Non-Hodgkin, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival (EFS)
EFS is defined as time from start of treatment/randomization up to event or to date of last contact for patients without event. The following occurrences are defined as an event: non-response, progressive disease or relapse, treatment related death, death of any other cause or diagnosis of secondary malignancies.
Measured: through study completion, maximal eight years
Immune reconstitution rate (only in intermediate/high risk patients
Immune reconstitution rate is defined as percentage of patients achieving age adjusted serum immunoglobulin levels 12 months after start of treatment.
Measured: 12 months after start of treatment
Secondary outcomes (6)
Overall survival (OS)
OS is defined as time from start of treatment/randomization up to death of any
Measured: through study completion, maximal eight years
Relapse-free survival (RFS)
RFS is defined as time from start of treatment/randomization up to event or to date of last contact for patients without event. The following occurrences are defined as an event: non-response, progressive disease, or relapse.
Measured: through study completion, maximal eight years
Response rate (RR)
Complete response, partial remission, objective effect, stable disease or progressive disease
Measured: on an average 3 weeks after finish of treatment
Adverse event rate
Rate of patients with acute toxicity defined as grade III/IV/V AE
Measured: from the first day of protocol defined treatment until two years after start of protocol defined treatment
Rate of patients achieving normal immunoglobulin level 12 months after start of treatment
Rate of patients achieving normal immunoglobulin level 12 months after start of treatment
Measured: 12 months after start of treatment
Time interval to normal immunoglobulin level
Time interval to normal immunoglobulin level
Measured: through study completion, maximal eight years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start5 May 2017
- Primary completion5 May 2022 (estimated)
- Study completion5 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for RituximabStudies of the same condition, open and under way.
- More trials run by 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao-Fei Sun, Sun Yat-sen University
- Investigators
- Sun Xiaofei, Master, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958916
- Sponsor's protocol ID
- SCCCG-BL/DLBCL-2017-001
- Status last verified
- May 2022
- First submitted
- 20 May 2019
- Last updated
- 9 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rosolen A, Perkins SL, Pinkerton CR, Guillerman RP, Sandlund JT, Patte C, Reiter A, Cairo MS. Revised International Pediatric Non-Hodgkin Lymphoma Staging System. J Clin Oncol. 2015 Jun 20;33(18):2112-8. doi: 10.1200/JCO.2014.59.7203. Epub 2015 May 4.
PubMed 25940716Bakhshi S, Radhakrishnan V, Sharma P, Kumar R, Thulkar S, Vishnubhatla S, Dhawan D, Malhotra A. Pediatric nonlymphoblastic non-Hodgkin lymphoma: baseline, interim, and posttreatment PET/CT versus contrast-enhanced CT for evaluation--a prospective study. Radiology. 2012 Mar;262(3):956-68. doi: 10.1148/radiol.11110936.
PubMed 22357895Goldman S, Smith L, Anderson JR, Perkins S, Harrison L, Geyer MB, Gross TG, Weinstein H, Bergeron S, Shiramizu B, Sanger W, Barth M, Zhi J, Cairo MS. Rituximab and FAB/LMB 96 chemotherapy in children with Stage III/IV B-cell non-Hodgkin lymphoma: a Children's Oncology Group report. Leukemia. 2013 Apr;27(5):1174-7. doi: 10.1038/leu.2012.255. Epub 2012 Sep 3. No abstract available.
PubMed 22940833Meinhardt A, Burkhardt B, Zimmermann M, Borkhardt A, Kontny U, Klingebiel T, Berthold F, Janka-Schaub G, Klein C, Kabickova E, Klapper W, Attarbaschi A, Schrappe M, Reiter A; Berlin-Frankfurt-Munster group. Phase II window study on rituximab in newly diagnosed pediatric mature B-cell non-Hodgkin's lymphoma and Burkitt leukemia. J Clin Oncol. 2010 Jul 1;28(19):3115-21. doi: 10.1200/JCO.2009.26.6791. Epub 2010 Jun 1.
PubMed 20516455
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenters Clinical Cohort Study on Efficacy and Safety of Stratified Treatment for Chinese Children With Burkitt Lymphoma/Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT03958916
- Acronym / sponsor ID
- SCCCG-BL/DLBCL-2017-001
- Conditions
- Rituximab, Lymphoma, Non-Hodgkin, Pediatric Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 5 May 2017 (actual)
- Primary completion
- 5 May 2022 (estimated)
- Study completion
- 5 May 2025 (estimated)
- First posted
- 22 May 2019 (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 trial SCCCG-BL/DLBCL-2017 is a collaborative prospective, multicenters, non-randomized, observational, cohort clinical study with participating centers of the South China Children's Cancer Group-Non-Hodgkin lymphoma group(SCCCG-NHL). The aim of the study is to evaluate efficacy and safety of stratified treatment based on risk factors of childhood and adolescents Burkitt lymphoma(BL)/diffuse large B-cell lymphoma(DLBCL) patients in china.
Detailed description
Research purposes:
- To investigate the efficacy and safety of SCCCG-BL/DLBCL-2017 in children with BL and DLBCL.
- To investigate the effect of rituximab combined with chemotherapy on the survival rate of children with high-risk BL/DLBCL.
- To investigate the effect of rituximab on immune function in children with high-risk BL/DLBCL.
- To explore the correlation between MRD detection and the efficacy and survival of children with BL/DLBCL.
- To explore the role of PET/CT in evaluating residual lesions in children after BL/DLBCL treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Burkitt lymphoma/diffuse large B-cell lymphoma patients，age at diagnosis < 18 years.
Key inclusion criteria (4 listed)
- Age < 18 years old
- Pathologically confirmed Burkitt lymphoma or diffuse large B-cell lymphoma
- Newly diagnosed patients
- Informed consent of guardian of children patients
Key exclusion criteria (2 listed)
- Pathological components with follicular lymphoma
- Immunodeficiency Second neoplasm
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
Event-free survival (EFS)
Time frame: through study completion, maximal eight years
EFS is defined as time from start of treatment/randomization up to event or to date of last contact for patients without event. The following occurrences are defined as an event: non-response, progressive disease or relapse, treatment related death, death of any other cause or diagnosis of secondary malignancies.
Immune reconstitution rate (only in intermediate/high risk patients
Time frame: 12 months after start of treatment
Immune reconstitution rate is defined as percentage of patients achieving age adjusted serum immunoglobulin levels 12 months after start of treatment.
6 secondary outcomes
Overall survival (OS)
Time frame: through study completion, maximal eight years
Relapse-free survival (RFS)
Time frame: through study completion, maximal eight years
Response rate (RR)
Time frame: on an average 3 weeks after finish of treatment
Adverse event rate
Time frame: from the first day of protocol defined treatment until two years after start of protocol defined treatment
Rate of patients achieving normal immunoglobulin level 12 months after start of treatment
Time frame: 12 months after start of treatment
Time interval to normal immunoglobulin level
Time frame: through study completion, maximal eight years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Results publication: PubMed 25940716Rosolen A, Perkins SL, Pinkerton CR, Guillerman RP, Sandlund JT, Patte C, Reiter A, Cairo MS. Revised International Pediatric Non-Hodgkin Lymphoma Staging System. J Clin Oncol. 2015 Jun 20;33(18):2112-8. doi: 10.1200/JCO.2014.59.7203. Epub 2015 May 4.
- Results publication: PubMed 22357895Bakhshi S, Radhakrishnan V, Sharma P, Kumar R, Thulkar S, Vishnubhatla S, Dhawan D, Malhotra A. Pediatric nonlymphoblastic non-Hodgkin lymphoma: baseline, interim, and posttreatment PET/CT versus contrast-enhanced CT for evaluation--a prospective study. Radiology. 2012 Mar;262(3):956-68. doi: 10.1148/radiol.11110936.
- Results publication: PubMed 22940833Goldman S, Smith L, Anderson JR, Perkins S, Harrison L, Geyer MB, Gross TG, Weinstein H, Bergeron S, Shiramizu B, Sanger W, Barth M, Zhi J, Cairo MS. Rituximab and FAB/LMB 96 chemotherapy in children with Stage III/IV B-cell non-Hodgkin lymphoma: a Children's Oncology Group report. Leukemia. 2013 Apr;27(5):1174-7. doi: 10.1038/leu.2012.255. Epub 2012 Sep 3. No abstract available.
- Results publication: PubMed 20516455Meinhardt A, Burkhardt B, Zimmermann M, Borkhardt A, Kontny U, Klingebiel T, Berthold F, Janka-Schaub G, Klein C, Kabickova E, Klapper W, Attarbaschi A, Schrappe M, Reiter A; Berlin-Frankfurt-Munster group. Phase II window study on rituximab in newly diagnosed pediatric mature B-cell non-Hodgkin's lymphoma and Burkitt leukemia. J Clin Oncol. 2010 Jul 1;28(19):3115-21. doi: 10.1200/JCO.2009.26.6791. Epub 2010 Jun 1.
- Individual participant dataSharing planned: No
Related trials for Rituximab
Active, not recruitingPhase 2/3
Efficacy and Safety of Obinutuzumab Versus Rituximab in Childhood Steroid Dependant and Frequent Relapsing Nephrotic Syndrome
Steroid-Dependent Nephrotic Syndrome, Steroid-Sensitive Nephrotic Syndrome
RecruitingPhase 3
A Study of Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) in Second-line (2L) + Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (MK-1026-010/BELLWAVE-010).
Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Chronic Lymphocytic
RecruitingPhase 3
A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Adult Patients With Previously Untreated Diffuse Large B-cell Lymphoma
Diffuse Large B-cell Lymphoma (DLBCL)
Active, not recruitingPhase 1/2
A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab As Monotherapy or Combined With Standard of Care Therapies in Adult Participants in China With B-Cell Non-Hodgkin Lymphoma
B-Cell Non-Hodgkin Lymphoma
RecruitingPhase 2
A Study of Pirtobrutinib, Venetoclax, and Rituximab in People With Waldenström's Macroglobulinemia (WM)/Lymphoplasmacytic Lymphoma (LPL)
Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma
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.
Sun Xiaofei, Master principal investigator
Sun Yat-sen University
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 Rituximab and Lymphoma, Non-Hodgkin, run by Sun Yat-sen 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 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 9 May 2022. 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 Sun Xiao-Fei (13600099837 ext. +86, sunxf@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival (EFS) (time frame: through study completion, maximal eight years). 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?
On the ClinicalTrials.gov record for NCT03958916, which also lists 4 linked publications.
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 9 May 2022.