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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00367497
Recruitment Status : Terminated (The stopping rule was applied because of low response rates.)
First Posted : August 23, 2006
Last Update Posted : November 20, 2007
Information provided by:
Keio University

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2005
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Primary Outcome Measures :
  1. Overall response

Secondary Outcome Measures :
  1. Complete response
  2. Safety
  3. Overall survival
  4. Progression free survival
  5. Effectiveness of peripheral blood stem cell collection

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00367497

Keio University School of Medicine
Tokyo, Japan, 160-8582
Sponsors and Collaborators
Keio University
Principal Investigator: Norihiro Awaya, MD, PhD Keio University Identifier: NCT00367497     History of Changes
Other Study ID Numbers: 17-40
First Posted: August 23, 2006    Key Record Dates
Last Update Posted: November 20, 2007
Last Verified: November 2007

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