R-ESHAP Followed by Autologous Transplantation for Refractory or Relapsed Diffused Large B-cell Lymphoma
NCT ID: NCT01278602
Last Updated: 2013-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
50 participants
INTERVENTIONAL
2010-12-31
2014-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Ye Guo
Dr.
Principal Investigators
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Ye Guo, MD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Fudan University Shanghai Cancer Center
Shanghai, , China
Countries
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Facility Contacts
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Other Identifiers
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LMTG 11-01
Identifier Type: -
Identifier Source: org_study_id
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