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

Sponsored by:	Fudan University
Information provided by:	Fudan University
ClinicalTrials.gov Identifier:	NCT00568815

Purpose

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).

Condition	Intervention	Phase
Lymphoma	Drug: Rituximab combined with ESHAP	Phase II

MedlinePlus related topics: Lymphoma

Drug Information available for: Cytarabine Cytarabine hydrochloride Etoposide Rituximab Etoposide phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Phase II Study of Rituximab Combined With ESHAP in Patients With Relapse or Refractory DLBCL

Further study details as provided by Fudan University:

Primary Outcome Measures:

Response rate [ Time Frame: every two cycles ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicities [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	April 2007
Estimated Study Completion Date:	December 2009

Arms	Assigned Interventions
A: Experimental	Drug: Rituximab combined with ESHAP 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

Detailed Description:

The salvage therapy in the patients with DLBCL is still controversial. We 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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00568815

Contacts

Contact: Biyun Wang, MD

8613701748410

wangbiyun@msn.com

Locations

China
Fudan University Cancer Hospital	Recruiting
Shanghai, China, 200032
Contact: Biyun Wang, MD 8613701748410 wangbiyun@msn.com
Sub-Investigator: Xiaonan Hong, M.D.

Sponsors and Collaborators

Fudan University

Investigators

Principal Investigator:

Biyun Wang, M.D.

Fudan University Cancer Hospital

More Information

Responsible Party:	Fudan University cancer hospital ( Base for drug clinical trials, Fudan University cancer hospital )
Study ID Numbers:	ESHAP-DLBCL
Study First Received:	December 5, 2007
Last Updated:	August 20, 2008
ClinicalTrials.gov Identifier:	NCT00568815
Health Authority:	China: Ethics Committee

Keywords provided by Fudan University:

DLBCL
Rituximab
ESHAP
Efficacy
Toxicity

Study placed in the following topic categories:

Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Rituximab
Etoposide phosphate
Lymphoma, B-Cell
Lymphoma, large-cell
Lymphatic Diseases

B-cell lymphomas
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Etoposide
Cytarabine

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Immune System Diseases
Antineoplastic Agents

Therapeutic Uses
Physiological Effects of Drugs
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009