- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00120198
Pegylated Liposomal Doxorubicin Containing Chemotherapy in the Treatment of Older Non-Hodgkin's Lymphoma Patients
November 15, 2007 updated by: Geriatric Oncology Consortium
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
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Oxnard, California, United States, 93030
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District of Columbia
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Washington, District of Columbia, United States, 20007
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Florida
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Inverness, Florida, United States, 34452
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Lecanto, Florida, United States, 34461
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New Jersey
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Belleville, New Jersey, United States, 07109
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To evaluate the feasibility and tolerability of CDOP plus rituximab in elderly patients with previously untreated NHL.
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Secondary Outcome Measures
Outcome Measure |
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overall survival
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Tumor response
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duration of response
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median time to disease progression
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Lodovico Balducci, MD, Geriatric Oncology Consortium
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2005
Study Completion (Actual)
September 1, 2006
Study Registration Dates
First Submitted
July 8, 2005
First Submitted That Met QC Criteria
July 8, 2005
First Posted (Estimate)
July 15, 2005
Study Record Updates
Last Update Posted (Estimate)
November 16, 2007
Last Update Submitted That Met QC Criteria
November 15, 2007
Last Verified
November 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma
- Lymphoma, Non-Hodgkin
- Physiological Effects of Drugs
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Rituximab
Other Study ID Numbers
- GOC-LY-010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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