IGEV Followed by Autologous Transplantation for Refractory or Relapsed Hodgkin Lymphoma

Phase II Study of IGEV Followed by Autologous Stem Cell Transplantation in Patients With Refractory or Relapsed Hodgkin Lymphoma.

The aim of study is to prove IGEV regimen followed by autologous stem cell transplantation as salvage treatment in patients with refractory or relapsed Hodgkin lymphoma is effective.

The standard treatment in patients with refractory or relapsed Hodgkin 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 IGEV regimen in a single-center basis.

Inclusion Criteria:

• Age range: 18-65 years old
• Histological confirmed refractory or relapsed Hodgkin lymphoma
• With at least one site of measurable disease according to IWC criteria
• 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≧80g/L
• Liver function: total bilirubin, ALT and AST <1.5×UNL
• Renal function: Cr<1.5×UNL, CCR≧45ml/min
• No contraindication for transplantation

Exclusion Criteria:

• No prior chemotherapy
• With more than 2 lines of prior chemotherapy exposure
• Evidence of CNS and bone marrow involvement
• History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
• Pregnant or lactating women
• Significant active infection