Status:

TERMINATED

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

Lead Sponsor:

Geriatric Oncology Consortium

Collaborating Sponsors:

Tibotec Pharmaceutical Limited

Conditions:

Non-Hodgkin's Lymphoma

Eligibility:

All Genders

65+ years

Phase:

PHASE2

Brief Summary

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, Pegylat...

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

March 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 1 2006

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT00120198

Start Date

March 1 2005

End Date

September 1 2006

Last Update

November 16 2007

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Oxnard, California, United States, 93030

2

Washington D.C., District of Columbia, United States, 20007

3

Inverness, Florida, United States, 34452

4

Lecanto, Florida, United States, 34461

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