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

NCT00367497 | Terminated Phase 2

• 1 other identifier: 17-40
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma, Non-Hodgkin

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Overall response

Secondary Outcomes (5)

• Complete response

• Safety

• Overall survival

• Progression free survival

• Effectiveness of peripheral blood stem cell collection

Interventions

Rituximab, Etoposide, Methylprednisolone, Cytarabine, Cisplatin DRUG

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Keio University: lead

Study Sites (1)

Keio University School of Medicine

Tokyo, 160-8582, Japan

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Rituximab; Etoposide; Methylprednisolone; Cytarabine; Cisplatin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Norihiro Awaya, MD, PhD

  Keio University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 22, 2006
• First Posted: August 23, 2006
• Study Start: August 1, 2005
• Study Completion: November 1, 2007
• Last Updated: November 20, 2007

Record last verified: 2007-11

Locations

JP (1)