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Trial Radar IA
Lo studio clinico NCT07493109 per Linfoma a Grandi Cellule B Diffuso (DLBCL) è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui.
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Chidamide for Maintenance Treatment of HBV-infected Diffuse DLBCL in Patients Initially Treated With R-CHOP Fase III 200

In arruolamento
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT07493109 è uno studio interventistico di Fase III volto a esaminare il trattamento per Linfoma a Grandi Cellule B Diffuso (DLBCL), attualmente in arruolamento. Avviato il 30 maggio 2026, prevede di arruolare 200 partecipanti. Sotto la guida di Ou Bai, MD/PHD, dovrebbe concludersi entro il 30 settembre 2030. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 25 marzo 2026.
Sommario breve
To evaluate the efficacy and safety of chidamide monotherapy as maintenance treatment in patients with diffuse large B-cell lymphoma (DLBCL) and HBV infection following initial response to R-CHOP therapy, and to provide evidence for the clinical application of chidamide.
Descrizione dettagliata
Primary endpoint is 2-year progression-free survival (PFS). Secondary endpoints include overall survival (OS), safety parameters, and exploratory biomarkers.
Titolo ufficiale

Evaluation of the Efficacy and Safety of Chidamide for Maintenance Treatment of HBV-infected Diffuse DLBCL in Patients Initially Treated With R-CHOP: A Prospective, Multicenter, Open-label Phase III Clinical Trial

Patologie
Linfoma a Grandi Cellule B Diffuso (DLBCL)
Altri ID dello studio
  • HBV-DLBCL
Numero NCT
NCT07493109
Data di inizio (effettiva)
2026-05-30
Ultimo aggiornamento pubblicato
2026-03-25
Data di completamento (stimata)
2030-09-30
Arruolamento (previsto)
200
Tipo di studio
Interventistico
FASE
Fase III
Stato
In arruolamento
Parole chiave
HBV-infected DLBCL
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
SperimentaleChidamide group
Chidamide is administered at a dose of 20 mg (4 tablets) twice weekly, i.e., on Days 1, 4, 8, 11, 15, 18, 22, and 25, with every 4 weeks constituting one treatment cycle. Standardized antiviral prophylaxis (e.g., Entecavir Tablets 0.5 mg daily)
Chidamide
Chidamide is administered at a dose of 20 mg (4 tablets) twice weekly, i.e., on Days 1, 4, 8, 11, 15, 18, 22, and 25, with every 4 weeks constituting one treatment cycle.
Comparatore attivoControl group
Standardized antiviral prophylaxis (e.g., Entecavir Tablets 0.5 mg daily)
Entecavir Tablets
Standardized antiviral prophylaxis (e.g., Entecavir Tablets 0.5 mg daily)
Esito primario
Misure di esitoDescrizione della misuraArco temporale
Progression-free survival (PFS)
The time from study enrollment to the first documented disease progression or death from any cause, whichever occurs first.
24 months
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
Overall Response Rate (ORR)
To assess the Overall Response Rate (ORR) referred to Lugano 2014.
24 months
Overall survival（OS）
Overall survival（OS） is defined as the time from the date of enrollment to the date of death from any cause.
24 months
Assistente alla partecipazione
Criteri di eleggibilità

Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
  1. Both sexes, age range ≥18 years and ≤80 years.
  2. No prior treatment for DLBCL, including chemotherapy, targeted therapy, immunotherapy, local radiotherapy for lymphoma (except local radiotherapy used to relieve tumor-related symptoms), or surgical treatment (except for tumor or pathological tissue biopsy and surgical resection not targeting lymphoma). Patients must have achieved complete response (CR) after 6 cycles of R-CHOP chemotherapy, confirmed by imaging (CT/PET-CT), bone marrow biopsy (if positive at baseline), and clinical assessment. Eligible patients will be randomly assigned in a 1:1 ratio to either the chidamide maintenance treatment group (experimental group) or the observation group (control group).
  3. Histopathologically confirmed diagnosis (all of the following conditions must be met simultaneously): Diffuse large B-cell lymphoma (DLBCL), and CD20-positive; Positive result for hepatitis B infection, defined as HBsAg positive, HBV DNA positive (>2000 IU/mL), or histopathological evidence of chronic HBV infection (without cirrhosis). Patients receiving ongoing antiviral therapy (e.g., nucleos(t)ide analogs) must have been on a stable regimen for ≥4 weeks prior to enrollment.
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  5. At screening, laboratory tests must meet the following criteria, unless judged by the investigator to be due to lymphoma (no corrective or supportive treatment for the parameters below within 2 weeks prior to assessment): Hematology: Hemoglobin (Hb) ≥ 90 g/L, Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, Platelet count (PLT) ≥ 90 × 10⁹/L; Biochemistry: Serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN); Total bilirubin (TBIL) ≤ 1.5 × ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN in cases of liver metastasis).
  6. Life expectancy of at least 6 months, as judged by the investigator.
  7. Understand and voluntarily sign a written informed consent form.

  1. Pregnant or breastfeeding women, and fertile patients unwilling to use contraceptive measures.
  2. Patients with a history of clinically significant QTc interval prolongation (males > 450 ms, females > 470 ms), ventricular tachycardia (VT), atrial fibrillation (AF), heart block, myocardial infarction (MI) within 1 year, congestive heart failure (CHF), or symptomatic coronary artery disease requiring medication.
  3. Patients who have undergone organ transplantation.
  4. Patients who received treatment for prior myelotoxicity as symptomatic therapy within 7 days before enrollment.
  5. Patients with active bleeding.
  6. Patients with a history or current diagnosis of thrombosis, embolism, cerebral hemorrhage, cerebral infarction, or other related conditions.
  7. Patients with active infection, or persistent fever within 14 days before enrollment.
  8. Patients who have not completed at least 6 weeks of recovery after major organ surgery.
  9. Patients with abnormal liver function (total bilirubin > 1.5 × upper limit of normal \[ULN\], ALT/AST > 2.5 × ULN, or > 5 × ULN in patients with liver involvement) or abnormal renal function (serum creatinine > 1.5 × ULN).
  10. Patients with mental disorders or those from whom informed consent cannot be obtained.
  11. Patients with drug abuse or chronic alcoholism that may interfere with the evaluation of trial results.
  12. Patients with lymphoma involving the central nervous system (CNS).
  13. Patients deemed by the investigator to be unsuitable for participation in this study.
Ou Bai, MD/PHD logoOu Bai, MD/PHD
Parte responsabile dello studio
Ou Bai, MD/PHD, Promotore-investigatore, Director, The First Hospital of Jilin University
Contatti principali dello studio
Contatto: Ou Bai, PHD, 15804302602, [email protected]
1 Centri dello studio in 1 paesi

Jilin

The First Bethune Hospital of Jilin University, Changchun, Jilin, China
Ou Bai, PHD, Contatto, 15804302602, [email protected]
In arruolamento