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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Non-Hodgkin's Lymphoma

Intervention / Treatment
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* Drug: CDOP plus rituximab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CDOP plus rituximab|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the feasibility and tolerability of CDOP plus rituximab in elderly patients with previously untreated NHL. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response |  |  | 
| duration of response |  |  | 
| median time to disease progression |  |  | 
| overall survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NHL, elderly