NCT00435955

Brief Summary

The purpose of this study is to determine whether an intensified treatment plus Rituximab followed by autologous transplantation is superior to a conventional chemotherapy regimen also supplemented with Rituximab.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2000

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 16, 2007

Completed
Last Updated

February 16, 2007

Status Verified

February 1, 2007

First QC Date

February 15, 2007

Last Update Submit

February 15, 2007

Conditions

Follicular Lymphoma

Keywords

Follicular lymphomaage adjusted IPI >1IIL score > 2Molecular remissionHigh dose chemotherapy and autologous transplantationRituximab

Outcome Measures

Primary Outcomes (1)

  • Event free survival at three years

Secondary Outcomes (7)

  • Overall survival

  • CR rate

  • Progression free survival

  • Disease free survival I

  • Incidence of secondary myelodisplasia and solid cancer

  • +2 more secondary outcomes

Interventions

High dose chemotherapy with autologous transplantationPROCEDURE
RituximabDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Follicular Lymphoma at diagnosis
  • Stage \>I
  • age-adjusted I.P.I. score 2 or 3 or three or more adverse factors of the I.L.I. score

You may not qualify if:

  • Serum positivity for HIV, HCV. HBsAg-positive only if active viral replication, assessed by HBV-DNA was present.
  • Major alterations of heart, lung, kidneys, liver, except for those directly disease-related;
  • Evidence of second tumors;
  • Previous chemotherapy( except patients who received limited radiotherapy);
  • Cerebral or CNS involvement.
  • Drug addiction or severe psychiatric disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Divisione di Ematologia Universitaria

Torino, 10154, Italy

Location

Related Publications (1)

  • Ladetto M, De Marco F, Benedetti F, Vitolo U, Patti C, Rambaldi A, Pulsoni A, Musso M, Liberati AM, Olivieri A, Gallamini A, Pogliani E, Rota Scalabrini D, Callea V, Di Raimondo F, Pavone V, Tucci A, Cortelazzo S, Levis A, Boccadoro M, Majolino I, Pileri A, Gianni AM, Passera R, Corradini P, Tarella C; Gruppo Italiano Trapianto di Midollo Osseo (GITMO); Intergruppo Italiano Linfomi (IIL). Prospective, multicenter randomized GITMO/IIL trial comparing intensive (R-HDS) versus conventional (CHOP-R) chemoimmunotherapy in high-risk follicular lymphoma at diagnosis: the superior disease control of R-HDS does not translate into an overall survival advantage. Blood. 2008 Apr 15;111(8):4004-13. doi: 10.1182/blood-2007-10-116749. Epub 2008 Jan 31.

    PMID: 18239086DERIVED

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Drug TherapyTransplantation, AutologousRituximab

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsTransplantationSurgical Procedures, OperativeAntibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Corrado Tarella, MD

    Università di Torino, Azienda Ospedaliera San Giovanni Battista

    PRINCIPAL INVESTIGATOR

  • Marco Ladetto, MD

    Università di Torino Azienda Ospedaliera San Giovanni Battista

    PRINCIPAL INVESTIGATOR

  • Alessandro Pileri, MD

    Università di Torino Azienda Ospedaliera San Giovanni Battista (Now retired)

    PRINCIPAL INVESTIGATOR

  • Mario Boccadoro

    Università di Torino/Azienda Ospedaliera San Giovanni Battista B

    PRINCIPAL INVESTIGATOR

  • Alessandro Gianni

    Istituto Tumori di Milano, Milano Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 15, 2007

First Posted

February 16, 2007

Study Start

March 1, 2000

Last Updated

February 16, 2007

Record last verified: 2007-02

Locations

IT(1)