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

Primary Purpose

Lymphoma, Non-Hodgkin

Status

Terminated

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

Rituximab, Etoposide, Methylprednisolone, Cytarabine, Cisplatin

About this trial

This is an interventional treatment trial for Lymphoma, Non-Hodgkin focused on measuring aggressive non-Hodgkin's lymphoma, salvage chemotherapy, rituximab

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Keio University School of Medicine

Outcomes

Primary Outcome Measures

Overall response

Secondary Outcome Measures

Complete response

Safety

Overall survival

Progression free survival

Effectiveness of peripheral blood stem cell collection

Full Information

NCT ID

NCT00367497

First Posted

August 22, 2006

Last Updated

November 19, 2007

Sponsor

Keio University

1. Study Identification

Unique Protocol Identification Number

NCT00367497

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2007

Overall Recruitment Status

Terminated

Why Stopped

The stopping rule was applied because of low response rates.

Study Start Date

August 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Keio University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma, Non-Hodgkin

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Rituximab, Etoposide, Methylprednisolone, Cytarabine, Cisplatin

Primary Outcome Measure Information:

Title

Overall response

Secondary Outcome Measure Information:

Title

Complete response

Title

Safety

Title

Overall survival

Title

Progression free survival

Title

Effectiveness of peripheral blood stem cell collection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

69 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Norihiro Awaya, MD, PhD

Organizational Affiliation

Keio University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Keio University School of Medicine

City

Tokyo

ZIP/Postal Code

160-8582

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

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

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