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

NCT ID: NCT00120198

Last Updated: 2007-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2006-09-30

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.

Conditions

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Non-Hodgkin's Lymphoma

Keywords

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NHL elderly

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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CDOP plus rituximab

Intervention Type DRUG

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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tibotec Pharmaceutical Limited

INDUSTRY

Sponsor Role collaborator

Geriatric Oncology Consortium

OTHER

Sponsor Role lead

Principal Investigators

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Lodovico Balducci, MD

Role: STUDY_CHAIR

Geriatric Oncology Consortium

Locations

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Oxnard, California, United States

Site Status

Washington D.C., District of Columbia, United States

Site Status

Inverness, Florida, United States

Site Status

Lecanto, Florida, United States

Site Status

Belleville, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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GOC-LY-010

Identifier Type: -

Identifier Source: org_study_id