Clinical trial · Interventional
Reduced Chemotherapy in Low Risk DLBCL
Four Cycles of R-CHOP Followed by Four Cycles of Rituximab Versus Six Cycles of R-CHOP Followed by Two Cycles of Rituximab in the Treatment of de Novo, Low-risk, Non-bulky Diffuse Large B-cell Lymphoma.
NCT02752815CI-TRIAL-00062474unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- 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 clinical trial to compare the efficacy and safety of four cycles of R-CHOP followed by four cycles of Rituximab with six cycles of R-CHOP followed by two cycles of Rituximab in the treatment of de novo, low-risk, non-bulky diffuse large B-cell lymphoma.
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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Epirubicin | Drug | Epirubicin | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
| Vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 6R-CHOP+2R
- description
- 6 cycles of R-CHOP Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Epirubicin 70mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Frequency 21days 2 cycles of Rituximab monotherapy Rituximab 375 mg/m2 IV d1 Frequency 21days
- interventionNames
- Drug: Rituximab
- Drug: Cyclophosphamide
- Drug: Epirubicin
- Drug: Vincristine
- Drug: Prednisone
- type
- EXPERIMENTAL
- label
- 4R-CHOP+4R
- description
- 4 cycles of R-CHOP Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Epirubicin 70mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Frequency 21days 2 cycles of Rituximab monotherapy Rituximab 375 mg/m2 IV d1 Frequency 21days
- interventionNames
- Drug: Rituximab
- Drug: Cyclophosphamide
- Drug: Epirubicin
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed de novo diffuse large B-cell lymphoma, complete response after 4 cycles of standard R-CHOP21 * Age\>=14 y.o.,\<=75 y.o. * IPI=0-1 * non-bulky (largest diameter \<7.5cm) * ECOG =0-1 * Life expectancy\>6 months * Informed consented Exclusion Criteria: * Chemotherapy before * Stem cell transplantation before * History of malignancy, except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix * Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease * Primary cutaneous, CNS DLBCL * LVEF≤50% * Other uncontrollable medical condition that may that may interfere the participation of the study * Lab at enrollment(unless caused by lymphoma) Neutrophile\<1.5\*10\^9/L Platelet\<80\*10\^9/L Hemoglobulin\<100g/L ALT or AST \>2\*ULN,AKP or bilirubin \>1.5\*ULN Creatinine\>1.5\*ULN * Not able to comply to the protocol for mental or other unknown reasons * Pregnant or lactation * If HbsAg positive, should check HBV DNA, DNA positive patients cannot be enrolled. If HBsAg negative but HBcAb positive (whatever HBsAb status), should check HBV DNA,DNA positive patients cannot be enrolled. * HIV infection
References
Publications (1)
- DERIVEDShi Q, He Y, Yi HM, Mu RJ, Jiang XF, Fu D, Dong L, Qin W, Xu PP, Cheng S, Song Q, Chen SJ, Wang L, Zhao WL. Positron emission tomography-adapted therapy in low-risk diffuse large B-cell lymphoma: results of a randomized, phase III, non-inferiority trial. Cancer Commun (Lond). 2023 Aug;43(8):896-908. doi: 10.1002/cac2.12462. Epub 2023 Jul 4. PMID 37403255