Safety and Efficacy Study of Salvage Chemotherapy (R-ESHAP) to Treat Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma

Phase 2 Study of Rituximab and ESHAP (Etoposide, Methylprednisolone, Cytarabine, and Cisplatin) in Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00367497

Enrollment

Registered

2006-08-23

Start date

2005-08-31

Completion date

2007-11-30

Last updated

2007-11-20

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

Conditions

Lymphoma, Non-Hodgkin

Keywords

aggressive non-Hodgkin's lymphoma, salvage chemotherapy, rituximab

Brief summary

Aggressive non-Hodgkin's lymphoma is difficult to handle once it relapses or becomes refractory to chemotherapy. Various second or third line chemotherapies, which are called salvage chemotherapy, were developed without promising results. Improvement in efficacy by adding relatively new agent, rituximab, to chemotherapy is now widely accepted in non-Hodgkin's lymphoma. This study will test the safety and efficacy of adding rituximab to existing salvage chemotherapy, ESHAP (R-ESHAP). Our aim is also to proceed to high-dose chemotherapy with autologous hematopoietic stem cell transplantation after successful R-ESHAP therapy.

Interventions

DRUGRituximab, Etoposide, Methylprednisolone, Cytarabine, Cisplatin

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 69 Years

Healthy volunteers

Inclusion criteria

* Clinical diagnosis of aggressive non-Hodgkin's lymphoma * Refractory to the first line chemotherapy or relapsed * Expression of CD20 on lymphoma cells * Measurable lesions on imaging studies

Exclusion criteria

* Blood cell counts not reaching to 3,000/microliter for white blood cells, 7 g/dl for hemoglobin, and 50,000/microliter for platelets without transfusion at the time of registration * Circulating lymphoma cells equal to or more than 25,000/microliter * Hepatic dysfunction * Renal insufficiency * Cardiac dysfunction or arrhythmia * Sever infection (bacterial, viral) * CNS involvement * Other malignancies * Pregnancy or breast feeding

Design outcomes

Primary

Measure	Time frame
Overall response	—

Secondary

Measure	Time frame
Complete response	—
Safety	—
Overall survival	—
Progression free survival	—
Effectiveness of peripheral blood stem cell collection	—

Countries

Japan

Outcome results

None listed

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