Diffuse Large B-cell Lymphoma
Conditions
Keywords
Rituximab, Gemcitabine, Oxaliplatin, Diffuse large B-cell lymphoma
Brief summary
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
Detailed description
Previous studies showed that the combination of rituximab, gemcitabine and oxaliplatin (R-GemOx) achieved high efficacy with a low toxicity profile in relapsed and refractory DLBCL. This regimen might be considered a putative treatment option for elderly patients. To our knowledge, the efficacy and safety of R-GemOx when given as first-line therapy in elderly patients with DLBCL remains unknown. The investigators therefore developed a two-weekly regimen of rituximab combined with GemOx regimen as first line treatment in elderly DLBCL and investigate its efficacy and safety. Primary Outcome Measures: * overall response rate Secondary Outcome Measures: * progression free survival * overall survival * safety and toxicity Enrollment: 60 Study Start Date: August 2012 Primary Completion Date: Dec 2015
Interventions
DRUGR-GemOx
Rituximab Gemcitabine Oxaliplatin
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall response rate | at the end of 3 cycles and 6 cycles of R-GemOx regimen(each cycle is 14 days) | overall response rate after 3 cycles and at the end of R-GemOx regimen. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| progression free survival | Two-year | from date of inclusion to date of progression, relapse from response, or death from any cause or last follow-up. |
| overall survival | Two-year | from the date of inclusion to date of death, irrespective of cause or last follow-up. |
| The incidence and severity of adverse events | Up to 30 days following the last dose of study drug | All the treatment related adverse events was evaluated according to common terminology criteria adverse events(CTCAE) version 4.0 |
Outcome results
None listed