R-ESHAP Followed by Autologous Transplantation for Refractory or Relapsed Diffused Large B-cell Lymphoma

Diffuse Large B-cell Lymphoma Clinical Trial

Official title:

A Multi-center Phase II Study of R-ESHAP Followed by Autologous Transplantation as Salvage Treatment for Patients With Refractory or Relapsed Diffuse Large B-cell Lymphoma.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01278602
• Other study ID #: LMTG 11-01
• Status: Recruiting
• Phase: Phase 2
• First received: January 18, 2011
• Last updated: March 2, 2013
• Start date: December 2010
• Est. completion date: February 2014

Study information

• Verified date: March 2013
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The aim of study is to prove R-ESHAP regimen followed by autologous stem cell transplantation as salvage treatment in patients with refractory or relapsed diffuse large B-cell lymphoma is effective.

Description:

The standard treatment in patients with refractory or relapsed diffuse large B-cell lymphoma is salvage chemotherapy followed by autologous transplantation for responsive patients. However, the standard of salvage chemotherapy remains uncertain. This study is to evaluate the efficacy and safety of R-ESHAP regimen in a multi-center basis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age range: 18-65 years old

• 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:

• Evidence of CNS and bone marrow involvement

• 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

Study Design

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

Related Conditions & MeSH terms

• Diffuse Large B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate		6 weeks	No
Secondary	3-year progression-free survival rate		3 years	No
Secondary	3-y overall survival rate		3 years	No