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
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring DLBCL, Rituximab, ESHAP, Efficacy, Toxicity
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
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
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
No
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
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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