Rituximab Combined With ESHAP in Patients With Relapse or Refractory Diffuse Large B Cell Lymphoma (DLBCL)

Fudan University

Status and phase

Completed

Phase 2

Conditions

Lymphoma

Treatments

Drug: Rituximab combined with ESHAP

Study type

Interventional

Funder types

Other

Identifiers

NCT00568815

ESHAP-DLBCL

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and toxicity of Rituximab combined with ESHAP (etoposide, methylprednisolone, cytarabine, and cisplatin) in the patients with diffuse large B cell lymphoma (DLBCL).

Full description

The salvage therapy in the patients with DLBCL is still controversial. The investigators conducted this study to evaluate the efficacy and tolerability of Rituximab combined with ESHAP in the patients with DLBCL. The patients enrolled were defined to be relapsed or refractory after the first-line chemotherapy like CHOP or other CHOP-like regimens.

Enrollment

31 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age range 18-70 years old
Histological confirmed diffuse large B cell lymphoma
ECOG performance status no more than 2
Life expectancy of more than 3 months
Relapse or refractory after the first-line chemotherapy of DLBCL
No evidence of bone marrow involvement
Normal laboratory values: hemoglobin > 8.0g/dl, neutrophil > 1.5×109/L, platelet > 80×109/L, serum creatine < 1× upper limitation of normal(ULN), serum bilirubin < 1× ULN, ALT and AST < 1.5× ULN

Exclusion criteria

Pregnant or lactating women
Serious uncontrolled diseases and intercurrent infection
The evidence of CNS metastasis and bone marrow involvement
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