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

NCT ID: NCT00568815

Last Updated: 2012-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2010-12-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chemo

Group Type EXPERIMENTAL

Rituximab combined with ESHAP

Intervention Type DRUG

Rituximab 375mg/m2 d1, VP-16 40mg/m2 d1-4, Ara-C 2g/m2 d5, DDP 25mg/m2 d1-4, Met 500mg/m2 d1-5

Interventions

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Rituximab combined with ESHAP

Rituximab 375mg/m2 d1, VP-16 40mg/m2 d1-4, Ara-C 2g/m2 d5, DDP 25mg/m2 d1-4, Met 500mg/m2 d1-5

Intervention Type DRUG

Other Intervention Names

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R-ESHAP

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Ye Guo

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Biyun Wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

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Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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ESHAP-DLBCL

Identifier Type: -

Identifier Source: org_study_id

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