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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. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 25, 2014