Pegylated Liposomal Doxorubicin Containing Chemotherapy in the Treatment of Older Non-Hodgkin's Lymphoma Patients

• Status: Terminated
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Currently there is no one standard of care for older patients with Non-Hodgkin's Lymphoma (NHL). The study will examine the tolerability and feasibility to the combination of Cyclophosphamide, Pegylated Liposomal Doxorubicin, Vincristine, Prednisone (CDOP) plus Rituximab.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Geriatric Oncology Consortium
• Collaborator: Tibotec Pharmaceutical Limited
• Treatments: Doxorubicin; Liposomal doxorubicin; Rituximab

Criteria

Inclusion Criteria:

• Age 65 years and older;

• Diagnosis of Non-Hodgkin's lymphoma where therapy with CHOP plus rituximab is considered;

• Previously untreated;

• ECOG 0-2

• Adequate renal and hepatic functions;

• Cardiac ejection fraction at least 50% by MUGA. No significant cardiac abnormalities by EKG;

• Signed informed consent

Exclusion Criteria:

• CNS involvement by lymphoma;

• Hypersensitivity to study drugs;

• Active infection;

• Prior treatment with monoclonal antibodies for cancer;

• History of cardiac disease with New York Heart Association Class II or greater or clinical evidence of congestive heart failure