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

This study has been completed.
Sponsor:
Information provided by:
Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie
ClinicalTrials.gov Identifier:
NCT00556127
First received: November 8, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Programma di Terapia Per Pazienti Affetti da Linfoma Diffuso a Grandi Cellule B CD20 Positive

Resource links provided by NLM:


Further study details as provided by Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie:

Primary Outcome Measures:
  • Failure-free survival [ Time Frame: Three years ]

Enrollment: 94
Study Start Date: June 2002
Study Completion Date: September 2006
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00556127

Locations
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
Istituto per la Ricerca e la Cura del Cancro, Candiolo
Torino, Italy
Ospedale di Chivasso e Ivrea
Torino, Italy
Osp. S. Giovanni Battista "Molinette"
Torino, Italy
Divisione di Medicina, Ospedale Generale E. Agnelli, Pinerolo
Torino, Italy
Stabilimento Ospedaliero Ciriè -
Torino, Italy
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) -
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00556127     History of Changes
Other Study ID Numbers: GIMURELL-DLBCL, Eudract Number 2004-000543-19
Study First Received: November 8, 2007
Last Updated: November 8, 2007
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie:
Large B-cell Lymphoma
Rituximab
ASCT

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Carmustine
Cyclophosphamide
Melphalan
Rituximab
Cytarabine
Dexamethasone
Epirubicin
Etoposide
Mitoxantrone
Prednisone
Vincristine
Lenograstim
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 28, 2014