R-ESHAP Followed by Autologous Transplantation for Refractory or Relapsed Diffused Large B-cell Lymphoma

• Status: Unknown status
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of study is to prove R-ESHAP regimen followed by autologous stem cell transplantation as salvage treatment in patients with refractory or relapsed diffuse large B-cell lymphoma is effective.

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

Details

• Lead Sponsor: Fudan University
• Treatments: Rituximab

Criteria

Inclusion Criteria:

• Age range: 18-65 years old

• Histological confirmed diffuse large B-cell lymphoma

• Refractory or first relapsed disease

• Prior anthracycline exposure

• Measurable disease

• ECOG performance status 0-1

• Life expectancy of more than 3 months

• Bone marrow function: ANC≧1.5×109/L, PLT≧100×109/L, Hb≧90g/L

• Liver function: total bilirubin, ALT and AST <1.5×UNL

• Renal function: Cr<1.5×UNL, CCR≧50ml/min

• No contraindication for transplantation

Exclusion Criteria:

• Evidence of CNS and bone marrow involvement

• More than 1 type of chemotherapy regimens exposure

• High level of HBV DNA

• Contraindication of high-dose methylprednisolone

• Pregnant or lactating women

• History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix

• History of allergic reaction/hypersensitivity to rituximab

• Significant active infection