Diffuse Large B-cell LymphomaNCT04726995
DLBCL Treatment in Children and Adolescents
An observational study of Diffuse Large B-cell Lymphoma, run by Sun Yat-sen University.
Trial summary
We compared the efficacy and safety of modified NHL-BFM-90 regimen and R-CHOP/CHOP regimen in pediatric (aged 0-14 years) and adolescent（aged 15-18 years）DLBCL patients in a single institution during a 20-year period. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Diffuse Large B-cell Lymphoma
- What is being tested?
- CHOP and BFM regiments
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2000to 1 Oct 2020
- How long will I take part?
- 60 Months
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: DLBCL patients aged 0-18 year-old
Who may be able to join
- patients who were pathologically diagnosed with DLBCL
- patients under 18 years of age.
Who cannot join
- Was administered prior chemotherapy;
- Patients who could not receive chemotherapy due to severe immunodeficiency or other diseases.
- Patients with primary central nervous system lymphomas.
About this study
Official title: Efficacy and Safety Comparison Between R-CHOP/CHOP and Modified NHL-BFM-90 Regimens in Children and Adolescents With Diffuse Large B-cell Lymphoma
We compared the efficacy and safety of modified NHL-BFM-90 regimen and R-CHOP/CHOP regimen in pediatric (aged 0-14 years) and adolescent（aged 15-18 years）DLBCL patients in a single institution during a 20-year period. we compared the efficacy and safety of modified NHL-BFM-90 regimen and R-CHOP/CHOP regimen in pediatric (aged 0-14 years) and adolescent（aged 15-18 years）DLBCL patients in a single institution during a 20-year period. To our best knowledge, no reports have been previously published regarding the comparison.
Read the detailed description
Diffuse large B-cell lymphoma (DLBCL) is an aggressive lymphoma that accounts for approximately 10%-20% of pediatric and adolescent non-Hodgkin's lymphomas (NHLs).
The incidence increases with age, with 37% of NHLs patients being adolescents aged. Poor survival has been demonstrated in adolescents and young adults compared to children with DLBCL. However, the Associazione Italiana Ematologia Oncologia Pediatrica (AIEOP) LNH-97 study showed that age was not a poor prognostic factor in children and adolescents with Burkitt lymphoma (BL) and DLBCL. A conclusion as to whether adolescent age is an independent risk factor has not been reached.
At present, the preferred protocols for adolescent DLBCL patients have not been standardized. Adolescents with cancer have been designated as a vulnerable population, positioned between children and the adult population. Treatment strategies differ between adults and pediatric patients. The pediatric strategy for DLBCL was developed in parallel by the Berlin-Frankfurt-Münster (BFM) and French-American-British/Lymphomes Malins B (FAB/LMB) groups. The combination of rituximab plus Cyclophosphamide, Adriamycin, Vincristine, and Prednisone (R-CHOP) or R-CHOP-like chemotherapy regimens are the standard therapy for the treatment of adult patients with DLBCL. There is currently a lack of studies that have compared the treatment outcomes in adolescent patients with DLBCL who were administered pediatric or adult regimens. Hence, we retrospectively analyzed the clinical characteristics and prognostic factors in DLBCL patients, especially the efficacy and safety of the pediatric regimen (modified NHL-BFM-90) and adult regimen (R-CHOP/CHOP), between pediatric and adolescent DLBCL patients.
- Conditions
- Diffuse Large B-cell Lymphoma
- Being tested
- CHOP and BFM regiments
- Keywords
- Children, Adolescent, Treatment, Modified NHL-BFM-90, R-CHOP
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHOP and BFM regimentsOther
used CHOP and BFM regiments
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
Overall survival (OS) was calculated from the date of diagnosis to death due to any cause or to the date of the last follow-up visit.
Measured: through study completion, an average of 58 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start1 Jan 2000
- Primary completion31 May 2020
- Study completion1 Oct 2020
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 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
- Other
- Time perspective
- Other
- Enrolment
- 106 participants (actual)
- Target duration
- 60 Months
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yizhuo Zhang, Sun Yat-sen University
- Investigators
- Yizhuo Zhang, Principal investigator, Sun Yat-sen University CancerCenter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726995
- Sponsor's protocol ID
- DLBCL treatment
- Status last verified
- Jan 2021
- First submitted
- 21 Jan 2021
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Comparison Between R-CHOP/CHOP and Modified NHL-BFM-90 Regimens in Children and Adolescents With Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT04726995
- Acronym / sponsor ID
- DLBCL treatment
- Conditions
- Diffuse Large B-cell Lymphoma
- Keywords
- Children, Adolescent, Treatment, Modified NHL-BFM-90, R-CHOP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2000 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 27 Jan 2021 (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.
We compared the efficacy and safety of modified NHL-BFM-90 regimen and R-CHOP/CHOP regimen in pediatric (aged 0-14 years) and adolescent（aged 15-18 years）DLBCL patients in a single institution during a 20-year period. we compared the efficacy and safety of modified NHL-BFM-90 regimen and R-CHOP/CHOP regimen in pediatric (aged 0-14 years) and adolescent（aged 15-18 years）DLBCL patients in a single institution during a 20-year period. To our best knowledge, no reports have been previously published regarding the comparison.
Detailed description
Diffuse large B-cell lymphoma (DLBCL) is an aggressive lymphoma that accounts for approximately 10%-20% of pediatric and adolescent non-Hodgkin's lymphomas (NHLs).
The incidence increases with age, with 37% of NHLs patients being adolescents aged. Poor survival has been demonstrated in adolescents and young adults compared to children with DLBCL. However, the Associazione Italiana Ematologia Oncologia Pediatrica (AIEOP) LNH-97 study showed that age was not a poor prognostic factor in children and adolescents with Burkitt lymphoma (BL) and DLBCL. A conclusion as to whether adolescent age is an independent risk factor has not been reached.
At present, the preferred protocols for adolescent DLBCL patients have not been standardized. Adolescents with cancer have been designated as a vulnerable population, positioned between children and the adult population. Treatment strategies differ between adults and pediatric patients. The pediatric strategy for DLBCL was developed in parallel by the Berlin-Frankfurt-Münster (BFM) and French-American-British/Lymphomes Malins B (FAB/LMB) groups. The combination of rituximab plus Cyclophosphamide, Adriamycin, Vincristine, and Prednisone (R-CHOP) or R-CHOP-like chemotherapy regimens are the standard therapy for the treatment of adult patients with DLBCL. There is currently a lack of studies that have compared the treatment outcomes in adolescent patients with DLBCL who were administered pediatric or adult regimens. Hence, we retrospectively analyzed the clinical characteristics and prognostic factors in DLBCL patients, especially the efficacy and safety of the pediatric regimen (modified NHL-BFM-90) and adult regimen (R-CHOP/CHOP), between pediatric and adolescent DLBCL patients.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 60 Months
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- DLBCL patients aged 0-18 year-old
Key inclusion criteria (2 listed)
- patients who were pathologically diagnosed with DLBCL
- patients under 18 years of age.
Key exclusion criteria (3 listed)
- Was administered prior chemotherapy;
- Patients who could not receive chemotherapy due to severe immunodeficiency or other diseases.
- Patients with primary central nervous system lymphomas.
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 |
|---|---|---|
| CHOP and BFM regimentsused CHOP and BFM regiments | Other | – |
Primary outcome
OS
Time frame: through study completion, an average of 58 months
Overall survival (OS) was calculated from the date of diagnosis to death due to any cause or to the date of the last follow-up visit.
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 27 Jan 2021.
- 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. This study is not recruiting at the moment.
Yizhuo Zhang principal investigator
Sun Yat-sen University CancerCenter
Questions about this trial
What is this clinical trial studying?
An observational study of Diffuse Large B-cell Lymphoma, run by 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 2 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 27 Jan 2021. 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?
OS (time frame: through study completion, an average of 58 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 27 Jan 2021.