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: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Alvin and Lois Lapidus Cancer Institute
• Collaborator: Ortho Biotech Products, L.P.
• Treatments: Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Prednisone; Rituximab; Vincristine

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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.