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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.


Phase 2
18 Years
65 Years
Open (Enrolling)
Both
Diffuse Large B-cell Lymphoma

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Trial Information

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.


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall response rate

Outcome Time Frame:

6 weeks

Safety Issue:

No

Principal Investigator

Ye Guo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University

Authority:

China: Ethics Committee

Study ID:

LMTG 11-01

NCT ID:

NCT01278602

Start Date:

December 2010

Completion Date:

February 2014

Related Keywords:

  • Diffuse Large B-Cell Lymphoma
  • Diffuse large B-cell lymphoma
  • Chemotherapy
  • R-ESHAP
  • Autologous stem cell transplantation
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

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