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

A Multi-center Phase II Study of R-ESHAP Followed by Autologous Transplantation as Salvage Treatment for Patients With Refractory or Relapsed Diffuse Large B-cell Lymphoma.

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.

The standard treatment in patients with refractory or relapsed diffuse large B-cell lymphoma is salvage chemotherapy followed by autologous transplantation for responsive patients. However, the standard of salvage chemotherapy remains uncertain. This study is to evaluate the efficacy and safety of R-ESHAP regimen in a multi-center basis.

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