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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00568815
• Other study ID #: ESHAP-DLBCL
• Status: Completed
• Phase: Phase 2
• First received: December 5, 2007
• Last updated: February 16, 2012
• Start date: April 2007
• Est. completion date: December 2010

Study information

• Verified date: February 2012
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Large B-Cell, Diffuse

Intervention

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

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		6 weeks	No
Secondary	Toxicities		every cycle	Yes