A Pilot Study of Cyclophosphamide/Pegylated Liposomal Doxorubicin/Vincristine/Prednisone (CDOP) Plus Rituximab for Treatment of Elderly Patients With Previously Untreated Non-Hodgkin's Lymphoma
65 Years
N/A
Both
Non-Hodgkin's Lymphoma
Trial Information
A Pilot Study of Cyclophosphamide/Pegylated Liposomal Doxorubicin/Vincristine/Prednisone (CDOP) Plus Rituximab for Treatment of Elderly Patients With Previously Untreated Non-Hodgkin's Lymphoma
Elderly NHL patients tend to tolerate the combination of cyclophosphamide, doxorubicin,
vincristine, and prednisone (CHOP) less well when compared to the younger population.
Cardiotoxicity, as well as neutropenia, are the most common side effects in the elderly
population with age being a risk factor for doxorubicin induced cardiac toxicity. Treatment
related toxicity in the older population can preclude adequate therapy and potentially
contribute to poor outcomes. Pegylated liposomal doxorubicin has shown similar efficacy
with a significant lower incidence of cardiotoxicity ad significantly fewer cardiac events
compared with conventional doxorubicin. Exploration of alternative regimens to maximize
tolerability and thus enhance overall efficacy in this population is warranted. Both safety
and efficacy will be evaluated.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To evaluate the feasibility and tolerability of CDOP plus rituximab in elderly patients with previously untreated NHL.
Principal Investigator
Lodovico Balducci, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Geriatric Oncology Consortium
Authority:
United States: Institutional Review Board
Study ID:
GOC-LY-010
NCT ID:
NCT00120198
Start Date:
March 2005
Completion Date:
September 2006
Related Keywords:
- Non-Hodgkin's Lymphoma
- NHL
- elderly
- Lymphoma
- Lymphoma, Non-Hodgkin
Name | Location |
|---|---|
| Fountain Valley, California 92708 | |
| Miami, Florida 33176 | |
| Hackensack, New Jersey 07601 | |
| Washington, District of Columbia |
