DLBCL: Rituximab in Addition to Chemotherapy With Autologous Stem Cell Transplantation as Treatment Diffuse Large B-Cell Lymphoma

Sponsor
Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie (Other)
Overall Status
Completed
CT.gov ID
NCT00556127
Collaborator
(none)
94
Enrollment
14
Locations
1
Arm
51
Duration (Months)
6.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
94 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Programma di Terapia Per Pazienti Affetti da Linfoma Diffuso a Grandi Cellule B CD20 Positive
Study Start Date :
Jun 1, 2002
Actual Study Completion Date :
Sep 1, 2006

Arms and Interventions

ArmIntervention/Treatment
Experimental: 1

Drug: Rituximab
375 mg/m2 on day 1

Drug: Epirubicin
110 mg/m2 on day 3

Drug: Cyclophosphamide
1200 mg/m2 on day 3

Drug: Vincristine
1.4 mg/m2 (maximum 2 mg) on day 3

Drug: Prednisone
40 mg/m2 from day 1 to 5

Drug: Granulocyte-colony-stimulating factor
(G-CSF 5 μg/Kg/day) from day 5 to day 11

Drug: Mitoxantrone
8 mg/m2 for 3-day

Drug: Cytarabine ARA-C
2 g/m2/12 hours for six doses in 3-hour infusion

Drug: Dexamethasone
4 mg/m2/12 hours before ARA-C administration

Drug: Carmustine BCNU
300 mg/m2 on day -7

Drug: Etoposide
100 mg/m2/12 hours

Drug: Melphalan
140 mg/m2 on day -2

Radiation: Radiotherapy
Involved Field Radiotherapy (IF-RT)

Procedure: PBSC reinfusion
ASCT

Outcome Measures

Primary Outcome Measures

  1. Failure-free survival [Three years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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;

  • 0-2 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.

Exclusion Criteria:
  • 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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Az. Ospedaliera SS. Antonio e Biagio e Cesare ArrigoAlessandriaItaly
2Ospedale Regionale, Divisione di Oncologia,AostaItaly
3Azienda Ospedaliera Ospedale Policlinico ConsorzialeBariItaly
4Osp. degli InfermiBiellaItaly
5Spedali CiviliBresciaItaly
6Centro Trapianti Midollo Osseo, P.O. BusincoCagliariItaly
7Ospedale S. GerardoMonzaItaly
8Osp. maggiore della CaritàNovaraItaly
9Università degli Studi Policlinico MontelucePerugiaItaly
10Divisione di Medicina, Ospedale Generale E. Agnelli, PineroloTorinoItaly
11Istituto per la Ricerca e la Cura del Cancro, CandioloTorinoItaly
12Osp. S. Giovanni Battista "Molinette"TorinoItaly
13Ospedale di Chivasso e IvreaTorinoItaly
14Stabilimento Ospedaliero Ciriè -TorinoItaly

Sponsors and Collaborators

  • Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie

Investigators

  • Principal Investigator: Umberto Vitolo, MD, S.C. Ematologia II - OSP.S. GIOV.BATTISTA MOLINETTE - TORINO (TO) -

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00556127
Other Study ID Numbers:
  • GIMURELL-DLBCL
  • Eudract Number 2004-000543-19
First Posted:
Nov 9, 2007
Last Update Posted:
Nov 9, 2007
Last Verified:
Nov 1, 2007

Study Results

No Results Posted as of Nov 9, 2007