R-ESHAP Followed by Autologous Transplantation for Refractory or Relapsed Diffused Large B-cell Lymphoma
Phase 2
- Conditions
- Diffuse Large B-cell Lymphoma
- Interventions
- Drug: R-ESHAP
- Registration Number
- NCT01278602
- Lead Sponsor
- Fudan University
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description R-ESHAP R-ESHAP Rituximab 375mg/m2 at day 0, Meththylprednisolone 500mg IV at days 1 to 5, Etoposide 40mg/m2 at days 1 to 4, Cisplatin 25mg/m2 at days 1 to 4, Cytarabine 2000mg/m2 at day 5. Frequence of cycles: every 3 weeks. Numbers of cycles: 3 cycles.
- Primary Outcome Measures
Name Time Method Overall response rate 6 weeks
- Secondary Outcome Measures
Name Time Method 3-year progression-free survival rate 3 years 3-y overall survival rate 3 years
Trial Locations
- Locations (1)
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, China