NCT00568815

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_2 lymphoma

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 6, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

February 20, 2012

Status Verified

February 1, 2012

Enrollment Period

3.7 years

First QC Date

December 5, 2007

Last Update Submit

February 16, 2012

Conditions

Lymphoma

Keywords

DLBCLRituximabESHAPEfficacyToxicity

Outcome Measures

Primary Outcomes (1)

  • Response rate

    6 weeks

Secondary Outcomes (1)

  • Toxicities

    every cycle

Study Arms (1)

Chemo

EXPERIMENTAL
Drug: Rituximab combined with ESHAP

Interventions

Rituximab combined with ESHAPDRUG

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

Also known as: R-ESHAP
Chemo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Lymphoma

Interventions

ESAP protocol

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Biyun Wang, M.D.

    Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

December 5, 2007

First Posted

December 6, 2007

Study Start

April 1, 2007

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

February 20, 2012

Record last verified: 2012-02

Locations

CN(1)