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

NCT01278602 | Unknown Phase 2

• 1 other identifier: LMTG 11-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diffuse Large B-cell Lymphoma

Keywords

Diffuse large B-cell lymphoma; Chemotherapy; R-ESHAP; Autologous stem cell transplantation

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  6 weeks

Secondary Outcomes (2)

• 3-year progression-free survival rate

  3 years

• 3-y overall survival rate

  3 years

Study Arms (1)

R-ESHAP

EXPERIMENTAL

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.

Drug: R-ESHAP

Interventions

R-ESHAP DRUG

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.

Also known as: Mabthera

R-ESHAP

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Ye Guo, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 18, 2011
• First Posted: January 19, 2011
• Study Start: December 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: February 1, 2014
• Last Updated: March 5, 2013

Record last verified: 2013-03

Locations

CN (1)