Prognosis of Patients With Relapsed/Refractory Hodgkin Lymphoma Treated With IGEV Induction Therapy Before HDCT With AHSCT

NCT ID: NCT01478191

Last Updated: 2013-03-06

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

495 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-06-30

Brief Summary

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This is a retrospective analysis of a homogeneous cohort of patients with relapsed/refractory HL that received IGEV scheme as induction therapy to HDCT and AHSCT for reassess the most common prognostic factors and try to identify a prognostic score with clinical and therapeutic relevance by using 6 clinical tools:

1. B symptoms(yes/no)
2. relapse in previously irradiated areas(yes/no)
3. Ann Arbor Stage (III/IV vs I/II)
4. disease status at accrual (refractory vs relapsed)
5. Early relapse within 12 months of Complete Response (CR) versus late relapse after Complete Response (CR) lasting \> l2 months",
6. extranodal involvement (yes/no).

Detailed Description

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Conditions

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Hodgkin's Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patient with a history of classical HL relapsed/refractory which received IGEV regimen as induction therapy before high dose chemotherapy with AHSCT
* Age \>18 years
* Patients with relapsed/refractory disease after standard treatments (chemotherapy +/- radiotherapy) before IGEV induction regimen. (Relapsed = disease relapse after CR.

Refractory = non CR with last chemotherapy line, or progression during last treatment, or disease progression within three months from previous treatment completion).

* Availability of clinical data, laboratory values and CT scan results of patients enrolled, performed from diagnosis to the last follow-up
* Patient scheduled to receive three or four IGEV cycles as pretransplantation induction regimen.
* First IGEV course started before December 31st 2007
* Assessment of tumor response by Cheson 1999 criteria 11

Exclusion Criteria

* NONE
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Italiana Linfomi - ETS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Armando Santoro, Prof.

Role: PRINCIPAL_INVESTIGATOR

Istituto Clinico Humanitas

Monica Balzarotti, Dr.

Role: PRINCIPAL_INVESTIGATOR

Istituto Clinico Humanitas

Locations

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Istituto Oncologico del Mediterraneo

Catania, Catania, Italy

Site Status

Policlinico Maggiore

Milan, Italy, Italy

Site Status

Ospedale San Gennaro

Napoli, Italy, Italy

Site Status

Azienda Ospedaliera V. Cervello

Palermo, Italy, Italy

Site Status

Azienda Ospedaliera "Bianchi Melacrino Morelli"

Reggio Calabria, Italy, Italy

Site Status

Presidio Ospedaliero - Unità Complessa Ematologia

Treviso, Italy, Italy

Site Status

Ematologia e Trapianto IRCCS, Istituto Nazionale dei Tumori

Milan, Milano, Italy

Site Status

SCDU Ematologia, AOU Maggiore della Carità

Novara, Novara, Italy

Site Status

Ospedale dell'Angelo

Mestre, VE, Italy

Site Status

A.O.SS. Biagio, Antonio e Cesare Arrigo

Alessandria, , Italy

Site Status

AORN San G.Moscati

Avellino, , Italy

Site Status

Centro di riferimento Oncologico - Oncologia Medica A

Aviano (PN), , Italy

Site Status

Divisione di Ematologia Spedali Civili

Brescia, , Italy

Site Status

Ospedale di Circolo

Busto Arsizio - VA, , Italy

Site Status

Divisione di Ematologia Osp.Businco

Cagliari, , Italy

Site Status

Ospedale civile Divisione di Ematologia

Civitanova Marche (MC), , Italy

Site Status

Ospedale S Martino

Genova, , Italy

Site Status

Ospedale San Martino - Divisione di Ematologia

Genova, , Italy

Site Status

Ospedale Santa Maria Goretti

Latina, , Italy

Site Status

A O Papardo

Messina, , Italy

Site Status

Azienda Ospedaliero Universitaria Policlinico Gaetano Martino

Messina, , Italy

Site Status

Osp. San Carlo Borromeo Divisione di Oncologia Medica

Milan, , Italy

Site Status

Ospedale Niguarda CA' Granda

Milan, , Italy

Site Status

Policlinico di Modena - Università degli studi

Modena, , Italy

Site Status

AOU Federico II di Napoli

Napoli, , Italy

Site Status

Ospedale Umberto I UO Med. Interna Oncoematologia

Nocera Inferiore (SA), , Italy

Site Status

A.O. di Padova Divisione di Oncologia Medica

Padua, , Italy

Site Status

Policlinico P.Giaccone

Palermo, , Italy

Site Status

Fondazione Policlinico San Matteo

Pavia, , Italy

Site Status

Ospedale Santo Spirito Dipartimento di Ematologia

Pescara, , Italy

Site Status

Ospedale Civile G.da Saliceto - UOA Ematologia

Piacenza, , Italy

Site Status

AO Santa Maria Nuova

Reggio Emilia, , Italy

Site Status

Ospedale Oncologico regionale CROB

Rionero in Vulture (PZ), , Italy

Site Status

Ospedale S. Eugenio

Roma, , Italy

Site Status

Policlinico Università Tor Vergata

Roma, , Italy

Site Status

Univeristà La Sapienza

Roma, , Italy

Site Status

Clinica Humanitas

Rozzano (MI), , Italy

Site Status

IRCCS Casa Sollievo della Sofferenza

San Giovanni Rotondo (FG), , Italy

Site Status

Istituto di Ematologia Università degli studi di Sassari

Sassari, , Italy

Site Status

Ematologia II OspedaleSan Giovanni Battista Molinette

Torino, , Italy

Site Status

Countries

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Italy

Other Identifiers

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30

Identifier Type: OTHER

Identifier Source: secondary_id

IIL-ProHLRec

Identifier Type: -

Identifier Source: org_study_id

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