A Dose Study of Doxil in a Dose Dense, 14 Day CDOP/Rituximab Regimen for Patients With Diffuse Large B-Cell Non-Hodgkin Lymphoma (NHL)> 60 Years or With Compromised Cardiac Status.

Status unconfirmed · Phase 2

Conditions studied: Diffuse Large B Cell Lymphoma, Lymphoma, Non-Hodgkin

In brief

The purpose of this study is to evaluate the feasibility and tolerability of delivering a full dose, on time schedule of dose-dense CDOP-R (cyclophosphamide, doxil, vincristine, prednisone, and rituximab) in NHL.

Key facts

Study ID

NCT00333008

Run by

The Alvin and Lois Lapidus Cancer Institute

People needed

27

Starts

2006-05-01

Last updated by the study team

2006-09-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 60 years old and older or 18 years old and older with significant/potential cardiac morbidity
• Diagnosis of diffuse large B cell lymphoma, Ann Arbor stage I-IV, any International Prognostic Index (IPI) score.
• Previously untreated
• New York Heart Association (NYHA) classification of Class III or better
• Baseline ejection fraction (EF) > 25%
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3
• Unless attributable to NHL: absolute neutrophil count (ANC) > 1500/uL, platelets > 100,000/uL; hemoglobin > 9.0 g/dl
• Bilirubin < 1.5 mg/dL (unless related to lymphoma)
• Hepatic: transaminases < 2.5 x upper limit of normal (ULN) (unless related to lymphoma)
• Creatinine < 2.5 mg/dl (unless related to lymphoma)

You may not qualify if…

• No HIV+ individuals
• No primary central nervous system (CNS) lymphoma
• No pregnant or lactating women
• No serious active infection
• History of prior malignancy within the last 5 years other than subject's original cancer diagnosis listed in inclusion criteria with the exception of curatively treated basal cell carcinoma.

Where it is running

• Sinai Hospital of Baltimore — Baltimore, Maryland, United States (enrolling)
• Northwest Hospital Center — Randallstown, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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