Know Cancer

forgot password

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

Phase 2
18 Years
70 Years
Not Enrolling

Thank you

Trial Information

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

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.

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

Type of Study:


Study Design:

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

Outcome Measure:

Response rate

Outcome Time Frame:

6 weeks

Safety Issue:


Principal Investigator

Biyun Wang, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University


China: Ethics Committee

Study ID:




Start Date:

April 2007

Completion Date:

December 2010

Related Keywords:

  • Lymphoma
  • Rituximab
  • Efficacy
  • Toxicity
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse