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)

Enrollment

Locations

Arm

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 Disease	Intervention/Treatment	Phase
Diffuse Large B-Cell Lymphoma POOR PROGNOSIS	Drug: Rituximab Drug: Epirubicin Drug: Cyclophosphamide Drug: Vincristine Drug: Prednisone Drug: Granulocyte-colony-stimulating factor Drug: Mitoxantrone Drug: Cytarabine ARA-C Drug: Dexamethasone Drug: Carmustine BCNU Drug: Etoposide Drug: Melphalan Radiation: Radiotherapy Procedure: PBSC reinfusion	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

Arm	Intervention/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

Arm

Intervention/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

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:

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

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