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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


Phase 2
65 Years
N/A
Not Enrolling
Both
Non-Hodgkin's Lymphoma

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the feasibility and tolerability of CDOP plus rituximab in elderly patients with previously untreated NHL.

Principal Investigator

Lodovico Balducci, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Geriatric Oncology Consortium

Authority:

United States: Institutional Review Board

Study ID:

GOC-LY-010

NCT ID:

NCT00120198

Start Date:

March 2005

Completion Date:

September 2006

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • NHL
  • elderly
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location
Fountain Valley, California  92708
Miami, Florida  33176
Hackensack, New Jersey  07601
Washington, District of Columbia