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

Fudan University

Status and phase: Unknown; Phase 2

Conditions: Diffuse Large B-cell Lymphoma

Treatments: Drug: R-ESHAP

Study type: Interventional

Funder types: Other

Identifiers

NCT01278602

LMTG 11-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

R-ESHAP

Experimental group

Description:

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.

Treatment:

Drug: R-ESHAP