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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.)
Sponsor:
Information provided by:
Keio University
ClinicalTrials.gov Identifier:
NCT00367497
First received: August 22, 2006
Last updated: November 19, 2007
Last verified: November 2007
History of Changes
  Purpose

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:

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00367497

Locations
Japan
Keio University School of Medicine
Tokyo, Japan, 160-8582
Sponsors and Collaborators
Keio University
Investigators
Principal Investigator: Norihiro Awaya, MD, PhD Keio University School of Medicine
  More Information

No publications provided

ClinicalTrials.gov 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
rituximab

Additional relevant MeSH terms:
Aggression
Lymphoma
Lymphoma, Non-Hodgkin
Behavioral Symptoms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Etoposide phosphate
Rituximab
Cisplatin
Cytarabine
Etoposide
 Methylprednisolone Hemisuccinate
Prednisolone
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013