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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ye Guo, Fudan University
ClinicalTrials.gov Identifier:
NCT00568815
First received: December 5, 2007
Last updated: February 16, 2012
Last verified: February 2012

December 5, 2007
February 16, 2012
April 2007
December 2010   (final data collection date for primary outcome measure)
Response rate [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Response rate [ Time Frame: every two cycles ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00568815 on ClinicalTrials.gov Archive Site
Toxicities [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Rituximab Combined With ESHAP in Patients With Relapse or Refractory Diffuse Large B Cell Lymphoma (DLBCL)
Phase II Study of Rituximab Combined With ESHAP in Patients With Relapse or Refractory DLBCL

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).

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma
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
Experimental: Chemo
Intervention: Drug: Rituximab combined with ESHAP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00568815
ESHAP-DLBCL
No
Ye Guo, Fudan University
Fudan University
Not Provided
Principal Investigator: Biyun Wang, M.D. Fudan University
Fudan University
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP