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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Diffuse Large B-cell Lymphoma

Intervention / Treatment
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* Drug: R-ESHAP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: R-ESHAP<br>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. | Drug: R-ESHAP<br>* 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.<br>* Other names: Mabthera;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year progression-free survival rate |  | 3 years | 
| 3-y overall survival rate |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diffuse large B-cell lymphoma, Chemotherapy, R-ESHAP, Autologous stem cell transplantation