search
Back to results

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

Primary Purpose

Diffuse Large B-Cell Lymphoma, POOR PROGNOSIS

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Rituximab
Epirubicin
Cyclophosphamide
Vincristine
Prednisone
Granulocyte-colony-stimulating factor
Mitoxantrone
Cytarabine ARA-C
Dexamethasone
Carmustine BCNU
Etoposide
Melphalan
Radiotherapy
PBSC reinfusion
Sponsored by
Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B-Cell Lymphoma focused on measuring Large B-cell Lymphoma, Rituximab, ASCT

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Az. Ospedaliera SS. Antonio e Biagio e Cesare Arrigo
  • Ospedale Regionale, Divisione di Oncologia,
  • Azienda Ospedaliera Ospedale Policlinico Consorziale
  • Osp. degli Infermi
  • Spedali Civili
  • Centro Trapianti Midollo Osseo, P.O. Businco
  • Ospedale S. Gerardo
  • Osp. maggiore della Carità
  • Università degli Studi Policlinico Monteluce
  • Divisione di Medicina, Ospedale Generale E. Agnelli, Pinerolo
  • Istituto per la Ricerca e la Cura del Cancro, Candiolo
  • Osp. S. Giovanni Battista "Molinette"
  • Ospedale di Chivasso e Ivrea
  • Stabilimento Ospedaliero Ciriè -

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Failure-free survival

Secondary Outcome Measures

Full Information

First Posted
November 8, 2007
Last Updated
November 8, 2007
Sponsor
Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie
search

1. Study Identification

Unique Protocol Identification Number
NCT00556127
Brief Title
Rituximab in Addition to Chemotherapy With Autologous Stem Cell Transplantation as Treatment Diffuse Large B-Cell Lymphoma
Acronym
DLBCL
Official Title
Programma di Terapia Per Pazienti Affetti da Linfoma Diffuso a Grandi Cellule B CD20 Positive
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie

4. Oversight

Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B-Cell Lymphoma, POOR PROGNOSIS
Keywords
Large B-cell Lymphoma, Rituximab, ASCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
375 mg/m2 on day 1
Intervention Type
Drug
Intervention Name(s)
Epirubicin
Intervention Description
110 mg/m2 on day 3
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
1200 mg/m2 on day 3
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Description
1.4 mg/m2 (maximum 2 mg) on day 3
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
40 mg/m2 from day 1 to 5
Intervention Type
Drug
Intervention Name(s)
Granulocyte-colony-stimulating factor
Intervention Description
(G-CSF 5 μg/Kg/day) from day 5 to day 11
Intervention Type
Drug
Intervention Name(s)
Mitoxantrone
Intervention Description
8 mg/m2 for 3-day
Intervention Type
Drug
Intervention Name(s)
Cytarabine ARA-C
Intervention Description
2 g/m2/12 hours for six doses in 3-hour infusion
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
4 mg/m2/12 hours before ARA-C administration
Intervention Type
Drug
Intervention Name(s)
Carmustine BCNU
Intervention Description
300 mg/m2 on day -7
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Description
100 mg/m2/12 hours
Intervention Type
Drug
Intervention Name(s)
Melphalan
Intervention Description
140 mg/m2 on day -2
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
Involved Field Radiotherapy (IF-RT)
Intervention Type
Procedure
Intervention Name(s)
PBSC reinfusion
Intervention Description
ASCT
Primary Outcome Measure Information:
Title
Failure-free survival
Time Frame
Three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Umberto Vitolo, MD
Organizational Affiliation
S.C. Ematologia II - OSP.S. GIOV.BATTISTA MOLINETTE - TORINO (TO) -
Official's Role
Principal Investigator
Facility Information:
Facility Name
Az. Ospedaliera SS. Antonio e Biagio e Cesare Arrigo
City
Alessandria
Country
Italy
Facility Name
Ospedale Regionale, Divisione di Oncologia,
City
Aosta
Country
Italy
Facility Name
Azienda Ospedaliera Ospedale Policlinico Consorziale
City
Bari
Country
Italy
Facility Name
Osp. degli Infermi
City
Biella
Country
Italy
Facility Name
Spedali Civili
City
Brescia
Country
Italy
Facility Name
Centro Trapianti Midollo Osseo, P.O. Businco
City
Cagliari
Country
Italy
Facility Name
Ospedale S. Gerardo
City
Monza
Country
Italy
Facility Name
Osp. maggiore della Carità
City
Novara
Country
Italy
Facility Name
Università degli Studi Policlinico Monteluce
City
Perugia
Country
Italy
Facility Name
Divisione di Medicina, Ospedale Generale E. Agnelli, Pinerolo
City
Torino
Country
Italy
Facility Name
Istituto per la Ricerca e la Cura del Cancro, Candiolo
City
Torino
Country
Italy
Facility Name
Osp. S. Giovanni Battista "Molinette"
City
Torino
Country
Italy
Facility Name
Ospedale di Chivasso e Ivrea
City
Torino
Country
Italy
Facility Name
Stabilimento Ospedaliero Ciriè -
City
Torino
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs