NCT00333008

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 31, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 2, 2006

Completed
Last Updated

September 26, 2006

Status Verified

September 1, 2006

First QC Date

May 31, 2006

Last Update Submit

September 25, 2006

Conditions

Diffuse Large B Cell LymphomaLymphoma, Non-Hodgkin

Keywords

Diffuse Large B Cell LymphomaCDOPDose DenseAnne Arbor Stage I-IVAny IPI score

Outcome Measures

Primary Outcomes (2)

  • Safety assessment: National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTACAE) v3.0

  • Efficacy: tumor evaluations every three (q 3) cycles

Interventions

DoxilDRUG
CyclophosphamideDRUG
VincristineDRUG
PrednisoneDRUG
RituximabDRUG
PegfilgrastimDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

RECRUITING

Northwest Hospital Center

Randallstown, Maryland, 21133, United States

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, DiffuseLymphoma, Non-Hodgkin

Interventions

liposomal doxorubicinCyclophosphamideVincristinePrednisoneRituximabpegfilgrastim

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsAntibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Stephen Noga, MD, PhD

    Sinai Hospital of Baltimore, The Alvin and Lois Lapidus Cancer Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pam Nickoles, RN, BSN

CONTACT

410-601-0729pnickole@lifebridgehealth.org

Judy Bosley, RN, BSN

CONTACT

410-601-4392jbosley@lifebridgehealth.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 31, 2006

First Posted

June 2, 2006

Study Start

May 1, 2006

Last Updated

September 26, 2006

Record last verified: 2006-09

Locations

US(2)