Trial of R-GemOx Regimen in Previously Untreated Elderly Patients With DLBCL.

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University; WEI XU
• Treatments: Gemcitabine; Oxaliplatin; Rituximab

Criteria

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.