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

Diffuse Large B-Cell Lymphoma Clinical Trial

— DLBCL  

Official title:

Programma di Terapia Per Pazienti Affetti da Linfoma Diffuso a Grandi Cellule B CD20 Positive

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00556127
• Other study ID #: GIMURELL-DLBCL
• Secondary ID: Eudract Number 2
• Status: Completed
• Phase: Phase 2
• First received: November 8, 2007
• Last updated: November 8, 2007
• Start date: June 2002
• Est. completion date: September 2006

Study information

• Verified date: November 2007
• Source: Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diffuse Large B-Cell Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse
• POOR PROGNOSIS

Intervention

Drug:
• Rituximab
375 mg/m2 on day 1
• Epirubicin
110 mg/m2 on day 3
• Cyclophosphamide
1200 mg/m2 on day 3
• Vincristine
1.4 mg/m2 (maximum 2 mg) on day 3
• Prednisone
40 mg/m2 from day 1 to 5
• Granulocyte-colony-stimulating factor
(G-CSF 5 µg/Kg/day) from day 5 to day 11
• Mitoxantrone
8 mg/m2 for 3-day
• Cytarabine ARA-C
2 g/m2/12 hours for six doses in 3-hour infusion
• Dexamethasone
4 mg/m2/12 hours before ARA-C administration
• Carmustine BCNU
300 mg/m2 on day -7
• Etoposide
100 mg/m2/12 hours
• Melphalan
140 mg/m2 on day -2

Radiation:
• Radiotherapy
Involved Field Radiotherapy (IF-RT)

Procedure:
• PBSC reinfusion
ASCT

Locations

Country	Name	City	State
Italy	Az. Ospedaliera SS. Antonio e Biagio e Cesare Arrigo	Alessandria
Italy	Ospedale Regionale, Divisione di Oncologia,	Aosta
Italy	Azienda Ospedaliera Ospedale Policlinico Consorziale	Bari
Italy	Osp. degli Infermi	Biella
Italy	Spedali Civili	Brescia
Italy	Centro Trapianti Midollo Osseo, P.O. Businco	Cagliari
Italy	Ospedale S. Gerardo	Monza
Italy	Osp. maggiore della Carità	Novara
Italy	Università degli Studi Policlinico Monteluce	Perugia
Italy	Divisione di Medicina, Ospedale Generale E. Agnelli, Pinerolo	Torino
Italy	Istituto per la Ricerca e la Cura del Cancro, Candiolo	Torino
Italy	Osp. S. Giovanni Battista "Molinette"	Torino
Italy	Ospedale di Chivasso e Ivrea	Torino
Italy	Stabilimento Ospedaliero Ciriè -	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Failure-free survival		Three years