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

Lymphoma, Non-Hodgkin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00367497
• Other study ID #: 17-40
• Status: Terminated
• Phase: Phase 2
• First received: August 22, 2006
• Last updated: November 19, 2007
• Start date: August 2005
• Est. completion date: November 2007

Study information

• Verified date: November 2007
• Source: Keio University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• Rituximab, Etoposide, Methylprednisolone, Cytarabine, Cisplatin

Locations

Country	Name	City	State
Japan	Keio University School of Medicine	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Keio University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response
Secondary	Complete response
Secondary	Safety
Secondary	Overall survival
Secondary	Progression free survival
Secondary	Effectiveness of peripheral blood stem cell collection