NCT00004112

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy plus rituximab is more effective than combination chemotherapy alone for non-Hodgkin's lymphoma. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without rituximab in treating patients who have newly diagnosed non-Hodgkin's lymphoma that has not been treated previously.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Sep 1999

Shorter than P25 for phase_3 lymphoma

Geographic Reach
1 country

2 active sites

Status
completed

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

September 1, 1999

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 10, 1999

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2000

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

May 25, 2004

Completed
Last Updated

September 23, 2024

Status Verified

September 1, 2024

Enrollment Period

1.3 years

First QC Date

December 10, 1999

Last Update Submit

September 20, 2024

Conditions

Lymphoma

Keywords

stage II adult diffuse small cleaved cell lymphomastage II adult diffuse mixed cell lymphomastage II adult diffuse large cell lymphomastage III adult diffuse small cleaved cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse large cell lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse large cell lymphomastage III mantle cell lymphomastage IV mantle cell lymphomaanaplastic large cell lymphomastage II mantle cell lymphomastage II small lymphocytic lymphomastage II marginal zone lymphomastage III small lymphocytic lymphomastage III marginal zone lymphomastage IV small lymphocytic lymphomastage IV marginal zone lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Interventions

rituximabBIOLOGICAL
Also known as: Rituxan
CHOP regimenDRUG

Cyclophosphamide, vincristine and doxorubicin as a drip into the bloodstream (intravenously) and prednisolone (steroid) as tablets taken with or after food.

Also known as: cyclophosphamide, vincristine, doxorubicin, prednisolone
cyclophosphamideDRUG
Also known as: chemotherapy
doxorubicin hydrochlorideDRUG
Also known as: Lipodox, Lipodox 50, and Doxil
prednisoneDRUG
Also known as: Prednisone Intensol, Deltasone, Rayos, steroid
vincristine sulfateDRUG
Also known as: Oncovin

Eligibility Criteria

Age19 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed, newly diagnosed, aggressive (stage II-IV) B-cell non-Hodgkin's lymphoma, including but not limited to:
  • Mantle cell
  • Diffuse large cell
  • Diffuse mixed cell
  • Anaplastic large cell (B-cell type)
  • Diffuse small cleaved cell
  • Marginal zone lymphoma
  • CD20 positive
  • years old and over
  • WHO 0-2
  • Karnofsky 70-100%
  • Life expectancy at least 6 months
  • Absolute neutrophil count greater than 1,000/mm3 (unless due to non-Hodgkin's lymphoma (NHL) bone marrow involvement)
  • Bilirubin less than 3.0 mg/dL
  • Alkaline phosphatase less than 3 times upper limit of normal (ULN)
  • +4 more criteria

You may not qualify if:

  • No prior T-cell lymphoma
  • Not pregnant or nursing
  • No other serious disease or medical condition that would interfere with compliance
  • No other concurrent chemotherapy
  • No concurrent corticosteroids (unless for prevention of nausea or vomiting)
  • No concurrent radiotherapy No other concurrent investigational agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198-3330, United States

Location

MeSH Terms

Conditions

LymphomaLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Mantle-CellLymphoma, Large-Cell, AnaplasticLeukemia, Lymphocytic, Chronic, B-CellLymphoma, B-Cell, Marginal Zone

Interventions

RituximabVAP-cyclo protocolCyclophosphamideVincristineDoxorubicinPrednisoloneDrug Therapyliposomal doxorubicinPrednisoneSteroids

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellLymphoma, T-CellLeukemia, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesPregnadienetriolsPregnadienesPregnanesFused-Ring CompoundsTherapeuticsPregnadienediols

Study Officials

  • Julie M Vose, MD

    University of Nebraska

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 1999

First Posted

May 25, 2004

Study Start

September 1, 1999

Primary Completion

December 1, 2000

Study Completion

March 1, 2003

Last Updated

September 23, 2024

Record last verified: 2024-09

Locations

US(2)