NCT00556127

Brief Summary

The purpose of this trial was to evaluate efficacy and safety of adding Rituximab to dose-dense and High-Dose Chemotherapy (HDC) with Autologous Stem Cell Transplantation (ASCT) as first line treatment in young patients with DLBCL at Intermediate-High and High risk aaIPI score

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2002

Typical duration for phase_2

Geographic Reach
1 country

14 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

June 1, 2002

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 9, 2007

Completed
Last Updated

November 9, 2007

Status Verified

November 1, 2007

First QC Date

November 8, 2007

Last Update Submit

November 8, 2007

Conditions

Diffuse Large B-Cell LymphomaPOOR PROGNOSIS

Keywords

Large B-cell LymphomaRituximabASCT

Outcome Measures

Primary Outcomes (1)

  • Failure-free survival

    Three years

Study Arms (1)

1

EXPERIMENTAL
Drug: RituximabDrug: EpirubicinDrug: CyclophosphamideDrug: VincristineDrug: PrednisoneDrug: Granulocyte-colony-stimulating factorDrug: MitoxantroneDrug: Cytarabine ARA-CDrug: DexamethasoneDrug: Carmustine BCNUDrug: EtoposideDrug: MelphalanRadiation: RadiotherapyProcedure: PBSC reinfusion

Interventions

RituximabDRUG

375 mg/m2 on day 1

1
EpirubicinDRUG

110 mg/m2 on day 3

1
CyclophosphamideDRUG

1200 mg/m2 on day 3

1
VincristineDRUG

1.4 mg/m2 (maximum 2 mg) on day 3

1
PrednisoneDRUG

40 mg/m2 from day 1 to 5

1
Granulocyte-colony-stimulating factorDRUG

(G-CSF 5 μg/Kg/day) from day 5 to day 11

1
MitoxantroneDRUG

8 mg/m2 for 3-day

1
Cytarabine ARA-CDRUG

2 g/m2/12 hours for six doses in 3-hour infusion

1
DexamethasoneDRUG

4 mg/m2/12 hours before ARA-C administration

1
Carmustine BCNUDRUG

300 mg/m2 on day -7

1
EtoposideDRUG

100 mg/m2/12 hours

1
MelphalanDRUG

140 mg/m2 on day -2

1
RadiotherapyRADIATION

Involved Field Radiotherapy (IF-RT)

1
PBSC reinfusionPROCEDURE

ASCT

1

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • previously untreated aggressive B-cell lymphoma (Diffuse Large B-Cell,
  • Primary Mediastinal,
  • Follicular grade III b Lymphoma);
  • age 18 to 60;
  • III-IV Ann Arbor stage;
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS);
  • intermediate-high (IH) and high (H) risk score according to age-adjusted International Prognostic Index (IPI).
  • Patients with Primary Mediastinal Lymphoma were included only if they had advanced stage III or IV disease.

You may not qualify if:

  • HIV,
  • hepatitis B or C virus seropositivity;
  • CNS involvement at diagnosis;
  • abnormal renal, pulmonary and hepatic function;
  • left ventricular ejection fraction less than 45%;
  • pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Az. Ospedaliera SS. Antonio e Biagio e Cesare Arrigo

Alessandria, Italy

Location

Ospedale Regionale, Divisione di Oncologia,

Aosta, Italy

Location

Azienda Ospedaliera Ospedale Policlinico Consorziale

Bari, Italy

Location

Osp. degli Infermi

Biella, Italy

Location

Spedali Civili

Brescia, Italy

Location

Centro Trapianti Midollo Osseo, P.O. Businco

Cagliari, Italy

Location

Ospedale S. Gerardo

Monza, Italy

Location

Osp. maggiore della Carità

Novara, Italy

Location

Università degli Studi Policlinico Monteluce

Perugia, Italy

Location

Divisione di Medicina, Ospedale Generale E. Agnelli, Pinerolo

Torino, Italy

Location

Istituto per la Ricerca e la Cura del Cancro, Candiolo

Torino, Italy

Location

Osp. S. Giovanni Battista "Molinette"

Torino, Italy

Location

Ospedale di Chivasso e Ivrea

Torino, Italy

Location

Stabilimento Ospedaliero Ciriè -

Torino, Italy

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

RituximabEpirubicinCyclophosphamideVincristinePrednisoneGranulocyte Colony-Stimulating FactorMitoxantroneDexamethasoneCarmustineEtoposideMelphalanRadiotherapy

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsDoxorubicinDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsColony-Stimulating FactorsGlycoproteinsGlycoconjugatesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesBiological FactorsAnthraquinonesAnthronesAnthracenesQuinonesPregnadienetriolsSteroids, FluorinatedNitrosourea CompoundsUreaAmidesNitroso CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesGlucosidesPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsTherapeutics

Study Officials

  • Umberto Vitolo, MD

    S.C. Ematologia II - OSP.S. GIOV.BATTISTA MOLINETTE - TORINO (TO) -

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 8, 2007

First Posted

November 9, 2007

Study Start

June 1, 2002

Study Completion

September 1, 2006

Last Updated

November 9, 2007

Record last verified: 2007-11

Locations

IT(14)