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

Primary Purpose

Diffuse Large B-cell Lymphoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

R-ESHAP

About this trial

This is an interventional treatment trial for Diffuse Large B-cell Lymphoma focused on measuring Diffuse large B-cell lymphoma, Chemotherapy, R-ESHAP, Autologous stem cell transplantation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

R-ESHAP

Arm Description

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.

Outcomes

Primary Outcome Measures

Overall response rate

Secondary Outcome Measures

3-year progression-free survival rate

3-y overall survival rate

Full Information

NCT ID

NCT01278602

First Posted

January 18, 2011

Last Updated

March 2, 2013

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT01278602

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Unknown status

Study Start Date

December 2010 (undefined)

Primary Completion Date

December 2013 (Anticipated)

Study Completion Date

February 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diffuse Large B-cell Lymphoma

Keywords

Diffuse large B-cell lymphoma, Chemotherapy, R-ESHAP, Autologous stem cell transplantation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

R-ESHAP

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

R-ESHAP

Other Intervention Name(s)

Mabthera

Intervention Description

Primary Outcome Measure Information:

Title

Overall response rate

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

3-year progression-free survival rate

Time Frame

3 years

Title

3-y overall survival rate

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ye Guo, MD

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fudan University Shanghai Cancer Center

City

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ye Guo, MD

pattrick_guo@msn.com

First Name & Middle Initial & Last Name & Degree

Ye Guo, MD

12. IPD Sharing Statement

Learn more about this trial

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

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