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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00120198

Enrollment

Registered

2005-07-15

Start date

2005-03-31

Completion date

2006-09-30

Last updated

2007-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Hodgkin's Lymphoma

Keywords

NHL, elderly

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, Pegylated Liposomal Doxorubicin, Vincristine, Prednisone (CDOP) plus Rituximab.

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.

Interventions

DRUGCDOP plus rituximab

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Tumor response	—
duration of response	—
median time to disease progression	—
overall survival	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026