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

This study has been completed.
Information provided by (Responsible Party):
Ye Guo, Fudan University Identifier:
First received: December 5, 2007
Last updated: February 16, 2012
Last verified: February 2012
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).

Condition Intervention Phase
Drug: Rituximab combined with ESHAP
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Rituximab Combined With ESHAP in Patients With Relapse or Refractory DLBCL

Resource links provided by NLM:

Further study details as provided by Ye Guo, Fudan University:

Primary Outcome Measures:
  • Response rate [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • Toxicities [ Time Frame: every cycle ]

Enrollment: 31
Study Start Date: April 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chemo Drug: 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
Other Name: R-ESHAP

Detailed 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.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00568815

China, Shanghai
Fudan University Cancer Hospital
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Principal Investigator: Biyun Wang, M.D. Fudan University
  More Information

Responsible Party: Ye Guo, Dr., Fudan University Identifier: NCT00568815     History of Changes
Other Study ID Numbers: ESHAP-DLBCL
Study First Received: December 5, 2007
Last Updated: February 16, 2012

Keywords provided by Ye Guo, Fudan University:

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents processed this record on May 25, 2017