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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00120198
Recruitment Status : Terminated (slow accrual)
First Posted : July 15, 2005
Last Update Posted : November 16, 2007
Tibotec Pharmaceutical Limited
Information provided by:
Geriatric Oncology Consortium

July 8, 2005
July 15, 2005
November 16, 2007
March 2005
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To evaluate the feasibility and tolerability of CDOP plus rituximab in elderly patients with previously untreated NHL.
Same as current
Complete list of historical versions of study NCT00120198 on Archive Site
  • Tumor response
  • duration of response
  • median time to disease progression
  • overall survival
Same as current
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Pegylated Liposomal Doxorubicin Containing Chemotherapy in the Treatment of Older Non-Hodgkin's Lymphoma Patients
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.
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.
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Non-Hodgkin's Lymphoma
Drug: CDOP plus rituximab
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
September 2006
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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
Sexes Eligible for Study: All
65 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Geriatric Oncology Consortium
Tibotec Pharmaceutical Limited
Study Chair: Lodovico Balducci, MD Geriatric Oncology Consortium
Geriatric Oncology Consortium
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP