Clinical trial · Interventional
Chidamide With R-CHOP Regimen for DLBCL Patients
Chidamide With R-CHOP Regimen for de Novo, High Risk Diffuse Large B Cell Lymphoma (DLBCL): A Prospective, Signal Arm, Open Label Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
It's a prospective, single arm, open label phase II clinical trial, in which the safety and efficacy of Chidamide plus R-CHOP regimen is accessed in de novo DLBCL patients, who have received 2 courses of R-CHOP but only achieved PR or whose MRD tests for ctDNA revealed positive results. abbreviation: R-CHOP: the chemo-therapy regimen composed of Rituximab, cyclophosphoamide, etoposide, vincristine and prednisone. PR: partial remission; MRD:minimal residual disease;
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chidamide + R-CHOP regimen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treatment group
- description
- In this group, the patients will receive 2 courses of Chidamide+ R-CHOP regimen, the way of administration and dosage of the medicine used in the trial is as follows: Rituximab 375mg//m2, ivgtt,d1; CTX 750mg/m2, ivgtt,d2; EPI 70mg/m2, ivgtt,d2; VCR 1.4 mg/m2, ivgtt, d2; Pred 60 mg/m2, PO, d2-6; Chidamide 20mg/d,d1、4、8、11、14、18; one cycle every 21 days; abbreviation: CTX: cyclophosphamide;EPI:etoposide;VCR: vincristine;Pred:prednisone; R-CHOP:the chemo-therapy regimen composed of Rituximab, cyclophosphoamide; etoposide, vincristine and prednisone.
- interventionNames
- Drug: Chidamide + R-CHOP regimen
Primary outcomes (1)
- measure
- complete remission rate
- timeFrame
- every 3 months until 30 months after the last patient's enrollment
- description
- complete remission rate after treated by Chidamide+ R-CHOP regimen
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosed as diffuse large B-cell Lymphoma with positive CD20 results; 2. Age between 18 to 75 years old; 3. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2; 4. No history of malignant tumors, having no tumor other than DLBCL at the time of enrollment; 5. Life expectancy no less than 6 months 6. The patient or his/her attorney would be able to provide written consent for necessary examinations or procedures; 7. IPI mark\>1. Exclusion Criteria: 1. History of autologous stem cell transplantation; 2. History of other malignant tumors, except skin basal cell carcinoma and in situ cervical cancer; 3. With uncontrolled cardiovascular/ cerebrovascular disease, coagulation disorders, connective tissue disease, severe infectious diseases; 4. Lymphoma originated in the central nervous system; 5. Left ventricular ejection fraction ≦50% 6. Abnormal lab results in enrollment: 1. Neutrophil count: \<1.5\*109/L; 2. Platelet count \<75\*109/L; 3. AST or ALT \>2 times the upper limit of normal level,AKP and total bilirubin \>1.5 times the upper limit of normal level; 4. serum creatinine \>1.5 times the upper limit of normal level; 7. Other uncontrolled medical conditions which the investigators think might influence the results of the trial; 8. Patients with mental illnesses or other diseases that might not comply with the trial plan; 9. Women during pregnancy or lactation; 10. HIV positive patients; 11. HbsAg (+) patients with HBV DNA(+), can be enrolled only when his/her HBV DNA turns negative; patients with HBsAg(-) HBcAb(+) can be enrolled only when his/her HBV DNA turns negative;
References
Publications (0)
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