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

This study has been terminated.
(The stopping rule was applied because of low response rates.)
Information provided by:
Keio University Identifier:
First received: August 22, 2006
Last updated: November 19, 2007
Last verified: November 2007
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.

Condition Intervention Phase
Lymphoma, Non-Hodgkin
Drug: Rituximab, Etoposide, Methylprednisolone, Cytarabine, Cisplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of Rituximab and ESHAP (Etoposide, Methylprednisolone, Cytarabine, and Cisplatin) in Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma

Resource links provided by NLM:

Further study details as provided by Keio University:

Primary Outcome Measures:
  • Overall response

Secondary Outcome Measures:
  • Complete response
  • Safety
  • Overall survival
  • Progression free survival
  • Effectiveness of peripheral blood stem cell collection

Enrollment: 5
Study Start Date: August 2005
Study Completion Date: November 2007

Ages Eligible for Study:   18 Years to 69 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00367497

Keio University School of Medicine
Tokyo, Japan, 160-8582
Sponsors and Collaborators
Keio University
Principal Investigator: Norihiro Awaya, MD, PhD Keio University School of Medicine
  More Information Identifier: NCT00367497     History of Changes
Other Study ID Numbers: 17-40 
Study First Received: August 22, 2006
Last Updated: November 19, 2007
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Keio University:
aggressive non-Hodgkin's lymphoma
salvage chemotherapy

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Behavioral Symptoms
Etoposide phosphate
Methylprednisolone Hemisuccinate
Prednisolone acetate
Methylprednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors processed this record on October 26, 2016