Clinical trial · Interventional
Abbreviated R-CHOP in Completely Excised Stage I or II DLBCL
Phase 2 Study of Abbreviated 3 Cycles of Rituximab Plus CHOP (Cyclophosphamide, Adriamycin, Vincristine, and Prednisolone) Immunochemotherapy in Patients With Completely Excised Stage I or II CD20+ Diffuse Large B-cell Lymphoma
NCT01279902CI-TRIAL-00023233unknownPhase 2ClinicalTrials.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 study aims; to assess the efficacy of shortened systemic chemotherapy in patients with completely excised CD20 positive Diffuse Large B-cell Lymphoma (DLBCL) with Ann Arbor Stage I or II.
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 |
|---|---|---|---|
| Rituximab plus CHOP Immunochemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Rituximab plus CHOP Immunochemotherapy
- description
- Interventions: conventional R-CHOP every 3 weeks for 3 cycles * Rituximab 375 mg/M2 IV day 1 * Cyclophosphamide 750 mg/M2 IV day1 * Vincristine 1.5 mg/M2 (max. 2 mg) IV day1 * Prednisolone 50 mg bid day 1-5, every 3 weeks
- interventionNames
- Drug: Rituximab plus CHOP Immunochemotherapy
Primary outcomes (1)
- measure
- Disease-free survival
- timeFrame
- 2 years
- description
- Proportion of patients surviving 2 years after first R-CHOP chemotherapy with no relapse of DLBCL
Secondary outcomes (2)
- measure
- Overall survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who underwent curative resection of primary tumor * Pathologically confirmed CD20 positive diffuse large B-cell lymphoma (DLBCL) after surgical resection * Ann Arbor Stage I or II * No history of chemotherapy * Performance status: ECOG 0-2 * Age: 18 to 70 years old * Complete excision with negative resection margin on pathologic report after surgery * Cardiac ejection fraction ≥ 50% as measured by MUGA or 2D echocardiography without clinically significant abnormalities * Adequate renal function: serum creatinine level below 2 mg/dL (177μmol/L) * Adequate liver functions: Transaminase (AST/ALT) \< 3X upper normal value, Bilirubin \< 2X upper normal value * Adequate hematologic function: hemoglobin ≥ 9 g/dL, absolute neutrophil count (ANC) ≥ 1,500/mm3 and platelet count ≥ 75,000/mm3 * Informed consent Exclusion Criteria: * Patients with a known history of HIV (+) or HCV (+). However, HBV(+) patients are eligible if primary prophylaxis is given * Previous or concurrent cancer that is distinct in primary site or histology from DLBCL, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis \& T1). Any cancer curatively treated \> 3 years prior to entry is permitted * Pregnant or lactating women, women of childbearing potential not employing adequate contraception * Other serious illness or medical conditions 1. Unstable cardiac disease (i.e. congestive heart failure, arrhythmia symptomatic coronary artery disease) despite treatment, myocardial infarction within 6 months prior to study entry 2. History of significant neurological or psychiatric disorders including dementia or seizures 3. Active uncontrolled infection (viral, bacterial or fungal infection) 4. Other serious medical illnesses * Known hypersensitivity to any of the study drugs or their ingredients * Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy * Patient with B symptoms or Bulky disease
References
Publications (1)
- DERIVEDKang S, Cho H, Sohn BS, Oh SY, Lee WS, Lee SM, Yang DH, Huh J, Yoon DH, Suh C. Long-term follow-up of abbreviated R-CHOP chemoimmunotherapy for completely resected limited-stage diffuse large B cell lymphoma (CISL 12-09). Ann Hematol. 2020 Dec;99(12):2831-2836. doi: 10.1007/s00277-020-04284-z. Epub 2020 Sep 28. PMID 32989495