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

Sponsor

Fondazione Italiana Linfomi ONLUS (Other)

Overall Status

Completed

CT.gov ID

NCT01478191

Collaborator

(none)

495

Enrollment

Locations

Duration (Months)

12.4

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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:

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

Condition or Disease	Intervention/Treatment	Phase
Hodgkin's Lymphoma

Study Design

Study Type:

Observational

Anticipated Enrollment :

495 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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 Start Date :

May 1, 2010

Actual Study Completion Date :

Jun 1, 2011

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ospedale dell'Angelo	Mestre	VE	Italy
2	A.O.SS. Biagio, Antonio e Cesare Arrigo	Alessandria		Italy
3	AORN San G.Moscati	Avellino		Italy
4	Centro di riferimento Oncologico - Oncologia Medica A	Aviano (PN)		Italy
5	Divisione di Ematologia Spedali Civili	Brescia		Italy
6	Ospedale di Circolo	Busto Arsizio - VA		Italy
7	Divisione di Ematologia Osp.Businco	Cagliari		Italy
8	Istituto Oncologico del Mediterraneo	Catania		Italy	95029
9	Ospedale civile Divisione di Ematologia	Civitanova Marche (MC)		Italy
10	Ospedale S Martino	Genova		Italy
11	Ospedale San Martino - Divisione di Ematologia	Genova		Italy
12	Ospedale Santa Maria Goretti	Latina		Italy
13	A O Papardo	Messina		Italy
14	Azienda Ospedaliero Universitaria Policlinico Gaetano Martino	Messina		Italy
15	Policlinico Maggiore	Milano		Italy	20162
16	Ematologia e Trapianto IRCCS, Istituto Nazionale dei Tumori	Milano		Italy
17	Osp. San Carlo Borromeo Divisione di Oncologia Medica	Milano		Italy
18	Ospedale Niguarda CA' Granda	Milano		Italy
19	Policlinico di Modena - Università degli studi	Modena		Italy
20	AOU Federico II di Napoli	Napoli		Italy
21	Ospedale San Gennaro	Napoli		Italy
22	Ospedale Umberto I UO Med. Interna Oncoematologia	Nocera Inferiore (SA)		Italy
23	SCDU Ematologia, AOU Maggiore della Carità	Novara		Italy	28100
24	A.O. di Padova Divisione di Oncologia Medica	Padova		Italy
25	Azienda Ospedaliera V. Cervello	Palermo		Italy	90146
26	Policlinico P.Giaccone	Palermo		Italy
27	Fondazione Policlinico San Matteo	Pavia		Italy
28	Ospedale Santo Spirito Dipartimento di Ematologia	Pescara		Italy
29	Ospedale Civile G.da Saliceto - UOA Ematologia	Piacenza		Italy
30	Azienda Ospedaliera "Bianchi Melacrino Morelli"	Reggio Calabria		Italy	89124
31	AO Santa Maria Nuova	Reggio Emilia		Italy
32	Ospedale Oncologico regionale CROB	Rionero in Vulture (PZ)		Italy
33	Ospedale S. Eugenio	Roma		Italy
34	Policlinico Università Tor Vergata	Roma		Italy
35	Univeristà La Sapienza	Roma		Italy
36	Clinica Humanitas	Rozzano (MI)		Italy
37	IRCCS Casa Sollievo della Sofferenza	San Giovanni Rotondo (FG)		Italy
38	Istituto di Ematologia Università degli studi di Sassari	Sassari		Italy
39	Ematologia II OspedaleSan Giovanni Battista Molinette	Torino		Italy
40	Presidio Ospedaliero - Unità Complessa Ematologia	Treviso		Italy	31100