Clinical trial · Observational
A Study of Improving the Efficacy of Treatment in Diffused Large B Cell Lymphoma Patients
A Prospective , Multicenter, Randomized Phase III Study of Improving the Efficacy of Treatment in Diffused Large B Cell Lymphoma Patients
- 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)
This is a prospective , open, multicenter, randomized phase Ⅲ study. The investigators planed to include 732 untreated CD20 positive diffused large B cell lymphoma adults,to random to R-CHOP21, CHOP14 , R-CHOP14 regimen groups after signature the informed consents. The patients will receive safety assessment every cycles, and efficacy evaluation every 2 cycles. Every-two-months follow up will be received after finishing the treatment.
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 (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- A (R-CHOP21)
- description
- CHOP combined with Rituximab regimen(R-CHOP21) Treatment Arm A(R-CHOP21): Rituximab 375mg/m2 for injection on day1; cyclophosphamide(C), 750mg/m2 for injection on day2; doxorubicin(H), 50mg/m2 for injection on day2; and Vincristine(O), 1.4mg/m2 for injection on day2, prednisone(P) 60mg/m2 orally on days 2 to 6. The therapy was repeated every 21 days for a total of 6 cycles.
- label
- B (CHOP14)
- description
- Biweekly CHOP regimen (CHOP14) Treatment Arm B (CHOP14): cyclophosphamide(C), 750mg/m2 for injection on day1; doxorubicin(H), 50mg/m2 for injection on day1; and Vincristine(O), 1.4 mg/m2 for injection on day1, prednisone(P) 60mg/m2 orally on days 1 to 5. The therapy was repeated every 14 days for a total of 6 cycles.PS: G-CSF 1.0-2ug/kg/ d for subcutaneous injections will be administered on day 6 for a total use of 6-8 days.
- label
- C (R-CHOP14)
- description
- Biweekly CHOP combined with Rituximab regimen(R-CHOP14) Treatment Arm C (R-CHOP14): Rituximab 375mg/m2 for injection on day1; cyclophosphamide(C), 750mg/m2 for injection on day2; doxorubicin(H), 50mg/m2 for injection on day2; and Vincristine(O), 1.4mg/m2 for injection on day2, prednisone(P),60mg/m2 orally on days 2 to 6. The therapy was repeated every 14 days for a total of 6 cycles.PS: G-CSF 1.0-2ug/kg/ d for subcutaneous injections will be administered on day 7 for a total use of 6-8 days patients with bulky disease or extranodal lesion wil be received radiotherapy after finishing the chemotherapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 and ≤70 years old. * Histological documented untreated CD20(+) diffused large B cell lymphoma. * Measurable disease and evaluable lesion. * Never previously treated with radiotherapy, chemotherapy or surgery for malignant disease. * Normal Haematological,liver and kidney function (Neutrophil count ≥ 1.5 × 109/L ,hemoglobin ≥ 100g/L,platelets ≥ 100 × 109/L) * ECOG Performance status 0-3,Life expectancy of at least 3 months. * Without history of another malignancy * Without any conflict serious systemic disease * Without any accompany treatment(including steroids drugs) * Subjects must have signed and informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. * Female subjects must be practicing and effective methods of birth control for at least 6 months throughout and after study; and have a negative serum β-hCG pregnancy test at screening. Exclusion Criteria * Patients with prior clinical study within 3 months. * Secondary lymphoma induced by chemotherapy or radiotherapy for another malignancy * Transformed lymphoma * Primary central nervous system lymphoma or primary testis lymphoma * History of allergic reaction to any ectogenic proteins * Prior treatment for lymphoma . * History of another malignancy * Neutrophil count \< 1.0× 109/L ,hemoglobin \< 90g/L,platelets \< 90 × 109/L,concurrent treatment with systemic antibiotic or antiviral drug for active infection. * Decompensated heart failure, dilated cardiomyopathy, coronary artery disease with depression of ST-T for electrocardiogram, myocardial infarction within 6 months * Serious infective or organic disease * Kidney dysfunction not related to lymphoma(Creatinine clearance≥ 2× institutional upper limit of normal) * liver dysfunction not related to lymphoma(transaminase≥3× institutional upper limit of normal,and/or bilirubin≥2.0mg/dl) * clinical syndrome of encephalon functional disorder,serious psychosis * female subject who is pregnant or breast-feeding
References
Publications (1)
- DERIVEDHuang H, Li X, Zhu J, Ye S, Zhang H, Wang W, Wu X, Peng J, Xu B, Lin Y, Cao Y, Li H, Lin S, Liu Q, Lin T. Entecavir vs lamivudine for prevention of hepatitis B virus reactivation among patients with untreated diffuse large B-cell lymphoma receiving R-CHOP chemotherapy: a randomized clinical trial. JAMA. 2014 Dec 17;312(23):2521-30. doi: 10.1001/jama.2014.15704. PMID 25514302