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

This study is currently recruiting participants.
Verified March 2013 by Fudan University
Sponsor:
Information provided by (Responsible Party):
Ye Guo, Fudan University
ClinicalTrials.gov Identifier:
NCT01278602
First received: January 18, 2011
Last updated: March 2, 2013
Last verified: March 2013
History of Changes
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab
U.S. FDA Resources

Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 3-year progression-free survival rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • 3-y overall survival rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Ye Guo, Dr., Fudan University
ClinicalTrials.gov Identifier: NCT01278602     History of Changes
Other Study ID Numbers: LMTG 11-01
Study First Received: January 18, 2011
Last Updated: March 2, 2013
Health Authority: China: Ethics Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on May 16, 2013