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

Completed

• Conditions: Hodgkin's Lymphoma

• Registration Number: NCT01478191
• Lead Sponsor: Fondazione Italiana Linfomi - ETS

Brief Summary

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

Not available

Study Timeline

• Study Start: 2010-05
• Study Completion: 2011-06
• Study First Submitted: 2011-10-17
• Status Verified: 2011-11
• Study First Submitted QC: 2011-11-22
• Study First Posted: 2011-11-23
• Last Update Submitted: 2013-03-05
• Last Update Posted: 2013-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 495

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The prognostic score will be defined taking into account Overall Survival (OS).	4 years	Surviving patents will be censored at the date of last known to be alive.

Secondary Outcome Measures

Name	Time	Method
To evaluate the defined prognostic score in terms of Progression Free Survival (PFS)	4 years	response rate in terms of Complete Response (CR) response rate in terms of Overall Response Rate (ORR) To validate the prognostic scores in terms of PFS and in terms OS

Trial Locations

Locations (40)

A.O. di Padova Divisione di Oncologia Medica; 🇮🇹 Padova, Italy

Divisione di Ematologia Osp.Businco; 🇮🇹 Cagliari, Italy

Istituto Oncologico del Mediterraneo; 🇮🇹 Catania, Italy

Ospedale Santa Maria Goretti; 🇮🇹 Latina, Italy

Ospedale civile Divisione di Ematologia; 🇮🇹 Civitanova Marche (MC), Italy

Ospedale S Martino; 🇮🇹 Genova, Italy

Osp. San Carlo Borromeo Divisione di Oncologia Medica; 🇮🇹 Milano, Italy

Ospedale San Martino - Divisione di Ematologia; 🇮🇹 Genova, Italy

A O Papardo; 🇮🇹 Messina, Italy

Ospedale Umberto I UO Med. Interna Oncoematologia; 🇮🇹 Nocera Inferiore (SA), Italy

SCDU Ematologia, AOU Maggiore della Carità; 🇮🇹 Novara, Italy

Azienda Ospedaliera V. Cervello; 🇮🇹 Palermo, Italy

Ospedale San Gennaro; 🇮🇹 Napoli, Italy

Azienda Ospedaliera "Bianchi Melacrino Morelli"; 🇮🇹 Reggio Calabria, Italy

Ospedale Santo Spirito Dipartimento di Ematologia; 🇮🇹 Pescara, Italy

AO Santa Maria Nuova; 🇮🇹 Reggio Emilia, Italy

Clinica Humanitas; 🇮🇹 Rozzano (MI), Italy

Istituto di Ematologia Università degli studi di Sassari; 🇮🇹 Sassari, Italy

Ospedale S. Eugenio; 🇮🇹 Roma, Italy

Univeristà La Sapienza; 🇮🇹 Roma, Italy

Ospedale di Circolo; 🇮🇹 Busto Arsizio - VA, Italy

Ospedale Niguarda CA' Granda; 🇮🇹 Milano, Italy

AOU Federico II di Napoli; 🇮🇹 Napoli, Italy

AORN San G.Moscati; 🇮🇹 Avellino, Italy

Centro di riferimento Oncologico - Oncologia Medica A; 🇮🇹 Aviano (PN), Italy

Divisione di Ematologia Spedali Civili; 🇮🇹 Brescia, Italy

Azienda Ospedaliero Universitaria Policlinico Gaetano Martino; 🇮🇹 Messina, Italy

Policlinico Maggiore; 🇮🇹 Milano, Italy

Ematologia e Trapianto IRCCS, Istituto Nazionale dei Tumori; 🇮🇹 Milano, Italy

Ospedale dell'Angelo; 🇮🇹 Mestre, VE, Italy

A.O.SS. Biagio, Antonio e Cesare Arrigo; 🇮🇹 Alessandria, Italy

Fondazione Policlinico San Matteo; 🇮🇹 Pavia, Italy

Ospedale Civile G.da Saliceto - UOA Ematologia; 🇮🇹 Piacenza, Italy

Policlinico di Modena - Università degli studi; 🇮🇹 Modena, Italy

Policlinico P.Giaccone; 🇮🇹 Palermo, Italy

Ospedale Oncologico regionale CROB; 🇮🇹 Rionero in Vulture (PZ), Italy

Policlinico Università Tor Vergata; 🇮🇹 Roma, Italy

IRCCS Casa Sollievo della Sofferenza; 🇮🇹 San Giovanni Rotondo (FG), Italy

Ematologia II OspedaleSan Giovanni Battista Molinette; 🇮🇹 Torino, Italy

Presidio Ospedaliero - Unità Complessa Ematologia; 🇮🇹 Treviso, Italy