Clinical trial NCT01478191: Prognosis of Patients With Relapsed/Refractory Hodgkin Lymphoma Treated With IGEV Induction Therapy Before HDCT With AHSCT
Official title: Prognosis of Patients With Relapsed/Refractory Hl Treated With Combination of Ifosfamide, Gemcitabine and Vinorelbine(IGEV) Induction Therapy Before High-dose Chemotherapy (HDCT) With Autologous Hematopoietic Stem Cells Transplantation (AHSCT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hodgkin's Lymphoma
Keywords: Hodgkin's Lymphoma
Ifosfamide, Gemcitabine and Vinorelbine (IGEV)
High Dose Chemotherapy (HDCT)
Autologous Hematopoietic Stem Cells Transplantation (AHSCT)
Lead sponsor: Fondazione Italiana Linfomi - ETS
Sponsor class: OTHER
First posted: 2011-11-23
Enrollment: 495
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases of relapsed/refractory Hodgkin Limphoma (HL) which received full course IGEV scheme as induction therapy prior to HDCT with AHSCT from 1997 through 2007. Patients will be identified from archives of every single Center Registry database.

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).


Eligibility criteria: 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

Primary outcomes:
measure: The prognostic score will be defined taking into account Overall Survival (OS).
timeFrame: 4 years
Secondary outcomes:
measure: To evaluate the defined prognostic score in terms of Progression Free Survival (PFS)
timeFrame: 4 years
Other outcomes:
Locations:
city: Mestre
country: Italy
facility: Ospedale dell'Angelo
state: VE
city: Alessandria
country: Italy
facility: A.O.SS. Biagio, Antonio e Cesare Arrigo
city: Avellino
country: Italy
facility: AORN San G.Moscati
city: Aviano (PN)
country: Italy
facility: Centro di riferimento Oncologico - Oncologia Medica A
city: Brescia
country: Italy
facility: Divisione di Ematologia Spedali Civili
city: Busto Arsizio - VA
country: Italy
facility: Ospedale di Circolo
city: Cagliari
country: Italy
facility: Divisione di Ematologia Osp.Businco
city: Catania
country: Italy
facility: Istituto Oncologico del Mediterraneo
city: Civitanova Marche (MC)
country: Italy
facility: Ospedale civile Divisione di Ematologia
city: Genova
country: Italy
facility: Ospedale S Martino
city: Genova
country: Italy
facility: Ospedale San Martino - Divisione di Ematologia
city: Latina
country: Italy
facility: Ospedale Santa Maria Goretti
city: Messina
country: Italy
facility: A O Papardo
city: Messina
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico Gaetano Martino
city: Milano
country: Italy
facility: Policlinico Maggiore
city: Milano
country: Italy
facility: Ematologia e Trapianto IRCCS, Istituto Nazionale dei Tumori
city: Milano
country: Italy
facility: Osp. San Carlo Borromeo Divisione di Oncologia Medica
city: Milano
country: Italy
facility: Ospedale Niguarda CA' Granda
city: Modena
country: Italy
facility: Policlinico di Modena - Università degli studi
city: Napoli
country: Italy
facility: AOU Federico II di Napoli
city: Napoli
country: Italy
facility: Ospedale San Gennaro
city: Nocera Inferiore (SA)
country: Italy
facility: Ospedale Umberto I UO Med. Interna Oncoematologia
city: Novara
country: Italy
facility: SCDU Ematologia, AOU Maggiore della Carità
city: Padova
country: Italy
facility: A.O. di Padova Divisione di Oncologia Medica
city: Palermo
country: Italy
facility: Azienda Ospedaliera V. Cervello
city: Palermo
country: Italy
facility: Policlinico P.Giaccone
city: Pavia
country: Italy
facility: Fondazione Policlinico San Matteo
city: Pescara
country: Italy
facility: Ospedale Santo Spirito Dipartimento di Ematologia
city: Piacenza
country: Italy
facility: Ospedale Civile G.da Saliceto - UOA Ematologia
city: Reggio Calabria
country: Italy
facility: Azienda Ospedaliera "Bianchi Melacrino Morelli"
city: Reggio Emilia
country: Italy
facility: AO Santa Maria Nuova
city: Rionero in Vulture (PZ)
country: Italy
facility: Ospedale Oncologico regionale CROB
city: Roma
country: Italy
facility: Ospedale S. Eugenio
city: Roma
country: Italy
facility: Policlinico Università Tor Vergata
city: Roma
country: Italy
facility: Univeristà La Sapienza
city: Rozzano (MI)
country: Italy
facility: Clinica Humanitas
city: San Giovanni Rotondo (FG)
country: Italy
facility: IRCCS Casa Sollievo della Sofferenza
city: Sassari
country: Italy
facility: Istituto di Ematologia Università degli studi di Sassari
city: Torino
country: Italy
facility: Ematologia II OspedaleSan Giovanni Battista Molinette
city: Treviso
country: Italy
facility: Presidio Ospedaliero - Unità Complessa Ematologia
Study officials:
affiliation: Istituto Clinico Humanitas
name: Armando Santoro, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Istituto Clinico Humanitas
name: Monica Balzarotti, Dr.
role: PRINCIPAL_INVESTIGATOR
References: