Rituximab in Addition to Chemotherapy With Autologous Stem Cell Transplantation as Treatment Diffuse Large B-Cell Lymphoma
NCT ID: NCT00556127
Last Updated: 2007-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
94 participants
INTERVENTIONAL
2002-06-30
2006-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
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
Radiotherapy
Involved Field Radiotherapy (IF-RT)
PBSC reinfusion
ASCT
Interventions
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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
Radiotherapy
Involved Field Radiotherapy (IF-RT)
PBSC reinfusion
ASCT
Eligibility Criteria
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Inclusion Criteria
* 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
* hepatitis B or C virus seropositivity;
* CNS involvement at diagnosis;
* abnormal renal, pulmonary and hepatic function;
* left ventricular ejection fraction less than 45%;
* pregnancy.
18 Years
60 Years
ALL
No
Sponsors
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Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie
OTHER
Principal Investigators
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Umberto Vitolo, MD
Role: PRINCIPAL_INVESTIGATOR
S.C. Ematologia II - OSP.S. GIOV.BATTISTA MOLINETTE - TORINO (TO) -
Locations
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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, , Italy
Countries
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Other Identifiers
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Eudract Number 2004-000543-19
Identifier Type: -
Identifier Source: secondary_id
GIMURELL-DLBCL
Identifier Type: -
Identifier Source: org_study_id