Clinical trial · Interventional
Trial of R-GemOx Regimen in Previously Untreated Elderly Patients With DLBCL.
A Prospective, Single-arm, Open-label, Phase 2 Study to Evaluate Efficacy and Safety of R-GemOx Regimen as First-line Treatment in Elderly Patients With Diffuse Large B-cell Lymphoma (DLBCL).
NCT01670370CI-TRIAL-00037105unknownPhase 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)
The purpose of this study is to investigate efficacy and safety of GemOx(Gemcitabine and Oxaliplatin) combination with rituximab(R) as first-line treatment of elderly patients with DLBCL
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 |
|---|---|---|---|
| R-GemOx | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Rituximab+Gemcitabine+oxaliplatin (R-GemOx)
- description
- Rituximab: 375 mg/m2 IV day1, Gemcitabine 1g/m2 IV day 2, oxaliplatin 100mg/m2 IV day2(every 14 days)
- interventionNames
- Drug: R-GemOx
Primary outcomes (1)
- measure
- overall response rate
- timeFrame
- at the end of 3 cycles and 6 cycles of R-GemOx regimen(each cycle is 14 days)
- description
- overall response rate after 3 cycles and at the end of R-GemOx regimen.
Secondary outcomes (3)
- measure
- progression free survival
- timeFrame
- Two-year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion criteria: 1. Histologically confirmed CD20-positive DLBCL (The germinal center B-cell like (GCB) / non-GCB subtype was determined by immunohistochemistry in paraffin-embedded tissue using CD10, BCL6 and MUM1 protein markers based on Hans's algorithm); 2. New-diagnosed and untreated; 3. Age older than 70 years or older than 60 years with ECOG PS ≥2; 4. Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements. Exclusion Criteria: 1. Poor hepatic or renal function, defined as total serum bilirubin, transaminases or creatinine over two times of the upper limit of normal concentration; 2. Poor cardiac function greater than Grade II according to New York Heart Association Functional Classification; 3. Presence of Grade III nervous toxicity over two weeks; 4. Hepatitis B virus (HBV) load (HBV DNA) more than 1×105 copies/ml; 5. Concomitant malignancy other than DLBCL requiring treatment; 6. Concomitant with other hematologic diseases (such as leukemia, hemophilia, primary myelofibrosis) which is unsuitable to be enrolled into this clinical trial; 7. Contraindication to any drug in this regimen; 8. Active and severe infectious diseases, such as severe pheumonia or septicaemia; 9. Major surgery within three weeks; 10. Any medical, psychological or social conditions which might interfere with the investigators' assessment 11. In any conditions which investigator considered ineligible for this study.
References
Publications (3)
- BACKGROUNDLopez A, Gutierrez A, Palacios A, Blancas I, Navarrete M, Morey M, Perello A, Alarcon J, Martinez J, Rodriguez J. GEMOX-R regimen is a highly effective salvage regimen in patients with refractory/relapsing diffuse large-cell lymphoma: a phase II study. Eur J Haematol. 2008 Feb;80(2):127-32. doi: 10.1111/j.1600-0609.2007.00996.x. Epub 2007 Nov 20. PMID 18005385
- BACKGROUNDMeriggi F, Zaniboni A. Gemox: a widely useful therapy against solid tumors-review and personal experience. J Chemother. 2010 Oct;22(5):298-303. doi: 10.1179/joc.2010.22.5.298. PMID 21123151
- DERIVEDShen QD, Zhu HY, Wang L, Fan L, Liang JH, Cao L, Wu W, Xia Y, Li JY, Xu W. Gemcitabine-oxaliplatin plus rituximab (R-GemOx) as first-line treatment in elderly patients with diffuse large B-cell lymphoma: a single-arm, open-label, phase 2 trial. Lancet Haematol. 2018 Jun;5(6):e261-e269. doi: 10.1016/S2352-3026(18)30054-1. Epub 2018 May 8. PMID 29752199