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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2007-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Lymphoma, Non-Hodgkin

Keywords

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aggressive non-Hodgkin's lymphoma salvage chemotherapy rituximab

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Rituximab, Etoposide, Methylprednisolone, Cytarabine, Cisplatin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Norihiro Awaya, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Keio University

Locations

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Keio University School of Medicine

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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17-40

Identifier Type: -

Identifier Source: org_study_id