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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2013 by Ye Guo, Fudan University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01278602
First Posted: January 19, 2011
Last Update Posted: March 5, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ye Guo, Fudan University
  Purpose
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.

Condition Intervention Phase
Diffuse Large B-cell Lymphoma Drug: R-ESHAP Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center Phase II Study of R-ESHAP Followed by Autologous Transplantation as Salvage Treatment for Patients With Refractory or Relapsed Diffuse Large B-cell Lymphoma.

Resource links provided by NLM:


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

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

Secondary Outcome Measures:
  • 3-year progression-free survival rate [ Time Frame: 3 years ]
  • 3-y overall survival rate [ Time Frame: 3 years ]

Estimated Enrollment: 50
Study Start Date: December 2010
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: R-ESHAP
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.
Drug: R-ESHAP
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.
Other Name: Mabthera

Detailed 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01278602


Locations
China
Fudan University Shanghai Cancer Center Recruiting
Shanghai, China, 200032
Contact: Ye Guo, MD       pattrick_guo@msn.com   
Principal Investigator: Ye Guo, MD         
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Ye Guo, MD Fudan University
  More Information

Responsible Party: Ye Guo, Dr., Fudan University
ClinicalTrials.gov Identifier: NCT01278602     History of Changes
Other Study ID Numbers: LMTG 11-01
First Submitted: January 18, 2011
First Posted: January 19, 2011
Last Update Posted: March 5, 2013
Last Verified: March 2013

Keywords provided by Ye Guo, Fudan University:
Diffuse large B-cell lymphoma
Chemotherapy
R-ESHAP
Autologous stem cell transplantation

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin