Recruiting
Phase 2

Doxil & Rituximab

Sponsor:

The Alvin and Lois Lapidus Cancer Institute

Code:

NCT00333008

Conditions

Diffuse Large B Cell Lymphoma

Lymphoma, Non-Hodgkin

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Doxil

Cyclophosphamide

Vincristine

Prednisone

Rituximab

Study Details

Brief 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.

Conditions

Diffuse Large B Cell Lymphoma

Lymphoma, Non-Hodgkin

Study ID

NCT00333008

Start date

May, 2006

Status verified date

Sep, 2006

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

27 participants

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Doxil

Cyclophosphamide

Vincristine

Prednisone

Rituximab

Pegfilgrastim

Primary outcome measure

  • Safety assessment: National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTACAE) v3.0 [ Time Frame: undefined ]
  • Efficacy: tumor evaluations every three (q 3) cycles [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Pam Nickoles, RN, BSN

410-601-0729pnickole@lifebridgehealth.org

Judy Bosley, RN, BSN

410-601-4392jbosley@lifebridgehealth.org

Locations

Sinai Hospital of Baltimore

Recruiting

Baltimore, Maryland, United States, 21215

Contacts

Pam Nickoles, RN, BSN

410-601-0729pnickole@lifebridgehealth.org

Judy Bosley, RN, BSN

410-601-4392jbosley@lifebridgehealth.org

Principal Investigator:

Stephen Noga, MD, PhD

Northwest Hospital Center

Recruiting

Randallstown, Maryland, United States, 21133

Contacts

Pam Nickoles, RN, BSN

410-601-0729pnickole@lifebridgehealth.org

Judy Bosley, RN, BSN

410-601-4392jbosley@lifebridgehealth.org

Principal Investigator:

Stephen Noga, MD, PhD

More Information

Sponsor

The Alvin and Lois Lapidus Cancer Institute

Last update posted

Sep 26, 2006

Last verified

Sep, 2006

Keywords

  • Diffuse Large B Cell Lymphoma
  • CDOP
  • Dose Dense
  • Anne Arbor Stage I-IV
  • Any IPI score

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by The Alvin and Lois Lapidus Cancer Institute on 2006-09-26.