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Rituximab Combined With ESHAP in Patients With Relapse or Refractory Diffuse Large B Cell Lymphoma (DLBCL)

Primary Purpose

Lymphoma

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Rituximab combined with ESHAP

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring DLBCL, Rituximab, ESHAP, Efficacy, Toxicity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Age range 18-70 years old
Histological confirmed diffuse large B cell lymphoma
ECOG performance status no more than 2
Life expectancy of more than 3 months
Relapse or refractory after the first-line chemotherapy of DLBCL
No evidence of bone marrow involvement
Normal laboratory values: hemoglobin > 8.0g/dl, neutrophil > 1.5×109/L, platelet > 80×109/L, serum creatine < 1× upper limitation of normal(ULN), serum bilirubin < 1× ULN, ALT and AST < 1.5× ULN

Exclusion Criteria:

Pregnant or lactating women
Serious uncontrolled diseases and intercurrent infection
The evidence of CNS metastasis and bone marrow involvement
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

Sites / Locations

Fudan University Cancer Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chemo

Arm Description

Outcomes

Primary Outcome Measures

Response rate

Secondary Outcome Measures

Toxicities

Full Information

NCT ID

NCT00568815

First Posted

December 5, 2007

Last Updated

February 16, 2012

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT00568815

Brief Title

Rituximab Combined With ESHAP in Patients With Relapse or Refractory Diffuse Large B Cell Lymphoma (DLBCL)

Official Title

Phase II Study of Rituximab Combined With ESHAP in Patients With Relapse or Refractory DLBCL

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Completed

Study Start Date

April 2007 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2010 (Actual)

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 purpose of this study is to evaluate the efficacy and toxicity of Rituximab combined with ESHAP (etoposide, methylprednisolone, cytarabine, and cisplatin) in the patients with diffuse large B cell lymphoma (DLBCL).

Detailed Description

The salvage therapy in the patients with DLBCL is still controversial. The investigators conducted this study to evaluate the efficacy and tolerability of Rituximab combined with ESHAP in the patients with DLBCL. The patients enrolled were defined to be relapsed or refractory after the first-line chemotherapy like CHOP or other CHOP-like regimens.

6. Conditions and Keywords

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

Lymphoma

Keywords

DLBCL, Rituximab, ESHAP, Efficacy, Toxicity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Chemo

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Rituximab combined with ESHAP

Other Intervention Name(s)

R-ESHAP

Intervention Description

Rituximab 375mg/m2 d1, VP-16 40mg/m2 d1-4, Ara-C 2g/m2 d5, DDP 25mg/m2 d1-4, Met 500mg/m2 d1-5

Primary Outcome Measure Information:

Title

Response rate

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Toxicities

Time Frame

every cycle

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age range 18-70 years old Histological confirmed diffuse large B cell lymphoma ECOG performance status no more than 2 Life expectancy of more than 3 months Relapse or refractory after the first-line chemotherapy of DLBCL No evidence of bone marrow involvement Normal laboratory values: hemoglobin > 8.0g/dl, neutrophil > 1.5×109/L, platelet > 80×109/L, serum creatine < 1× upper limitation of normal(ULN), serum bilirubin < 1× ULN, ALT and AST < 1.5× ULN Exclusion Criteria: Pregnant or lactating women Serious uncontrolled diseases and intercurrent infection The evidence of CNS metastasis and bone marrow involvement 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Biyun Wang, M.D.

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fudan University Cancer Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

12. IPD Sharing Statement

Learn more about this trial

Rituximab Combined With ESHAP in Patients With Relapse or Refractory Diffuse Large B Cell Lymphoma (DLBCL)

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