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

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.

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01278602

Enrollment

Registered

2011-01-19

Start date

2010-12-31

Completion date

2014-02-28

Last updated

2013-03-05

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

Conditions

Diffuse Large B-cell Lymphoma

Keywords

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

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.

Detailed 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.

Interventions

DRUGR-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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Overall response rate	6 weeks

Secondary

Measure	Time frame
3-year progression-free survival rate	3 years
3-y overall survival rate	3 years

Countries

China

Outcome results

None listed

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