- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04726995
DLBCL Treatment in Children and Adolescents
Efficacy and Safety Comparison Between R-CHOP/CHOP and Modified NHL-BFM-90 Regimens in Children and Adolescents With Diffuse Large B-cell Lymphoma
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- patients who were pathologically diagnosed with DLBCL
- patients under 18 years of age.
Exclusion Criteria:
- Was administered prior chemotherapy;
- Patients who could not receive chemotherapy due to severe immunodeficiency or other diseases.
- Patients with primary central nervous system lymphomas.
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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OS
Tidsram: 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.
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through study completion, an average of 58 months
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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- DLBCL treatment
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