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

Phase 2TerminatedNCT00367497

Keio University5 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lymphoma, Non-Hodgkin

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 69 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Overall response

Secondary Outcomes

Complete response

Safety

Overall survival

Progression free survival

Effectiveness of peripheral blood stem cell collection