Trial of R-GemOx Versus R-miniCHOP Regimen in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · May 7, 2016

Keywords

ClinConnect Summary

Gemcitabine and Oxaliplatin(GemOx) shows effective activity in patients with relapsed diffuse large-cell lymphoma and other solid tumors. Our Previous study showed that two-weekly regimen of rituximab combined with GemOx regimen acheived comparable response rate to R-miniCHOP.The investigators therefore design this open-label,phase III and random trial to compared the safety and efficacy of R-Gemox versus R-miniCHOP as first-line treatment of elderly patients with diffuse large B cell lymphoma.

Primary Outcome Measures:

• 2-year overall survival rate

Secondary Outcome Measures:

* 2-year...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Histologically confirmed diffuse large B cell lymphoma（With exception of Primary mediastinal large B cell lymphoma、Primary central nervous system lymphoma、HIV-related lymphoma);
• • 2. New-diagnosed and untreated;
• • 3. Age older than 80 years or older than 70 years with ECOG PS ≥ 2;
• • 4. Ann Arbor stage I to stage IV disease;
• • 5. 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 and/or renal function, defined as total bilirubin, ALT, AST, Cr more than two fold of upper normal level, unless these abnormalities were related to the lymphoma;
• • 2. Poor bone-marrow reserve, defined as neutrophil count less than 1.5×10⁹/L or platelet count less than 75×10⁹/L, unless caused by bone marrow infiltration;
• • 3. Presence of Grade III nervous toxicity with two weeks;
• • 4. New York Heart Association class III or IV cardiac failure; or Ejection fraction less than 50%;or history of following disease in past 6 months: acute coronary syndrome、acute heart failure、severe ventricular arrhythmia
• • 5. Positive HIV, syphilis,HCV, or HBV virus load(HBV DNA)\> 1×10'4copies/ml;
• • 6. CNS or meningeal involvement;
• • 7. Concomitant malignancy other than aggressive B cell lymphoma and need to Treat, with the exception of non-melanoma skin tumours or stage 0 (in situ) cervical carcinoma,or history of cancer more than 5 years;
• • 8. Concomitant with other hematologic diseases(such as leukemia, hemophilia primary myelofibrosis) which investigator it unsuitable to be enrolled into this clinical trial;
• • 9. Active and severe infectious diseases;
• • 10. Major surgery within three weeks;
• • 11. Any potential drug abuse, medical, psychological or social conditions which may disturb this investigation and assessment.
• • 12. In any conditions which investigator considered ineligible for this study.
• • 13. Known sensitivity or allergy to investigational Product.