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

March 2, 2013 updated by: Ye Guo, Fudan University

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Mabthera

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall response rate
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
3-year progression-free survival rate
Time Frame: 3 years
3 years
3-y overall survival rate
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

February 1, 2014

Study Registration Dates

First Submitted

January 18, 2011

First Submitted That Met QC Criteria

January 18, 2011

First Posted (Estimate)

January 19, 2011

Study Record Updates

Last Update Posted (Estimate)

March 5, 2013

Last Update Submitted That Met QC Criteria

March 2, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LMTG 11-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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