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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00568815

Enrollment

Registered

2007-12-06

Start date

2007-04-30

Completion date

2010-12-31

Last updated

2012-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

Keywords

DLBCL, Rituximab, ESHAP, Efficacy, Toxicity

Brief 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).

Detailed 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.

Interventions

DRUGRituximab 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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Response rate	6 weeks

Secondary

Measure	Time frame
Toxicities	every cycle

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026