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

Hodgkin's Lymphoma Clinical Trial

— IIL-ProHLRec  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01478191
• Other study ID #: IIL-ProHLRec
• Secondary ID: 30
• Status: Completed
• Phase: N/A
• First received: October 17, 2011
• Last updated: March 5, 2013
• Start date: May 2010
• Est. completion date: June 2011

Study information

• Verified date: November 2011
• Source: Fondazione Italiana Linfomi ONLUS
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 495
• Est. completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin's Lymphoma

Locations

Country	Name	City	State
Italy	A.O.SS. Biagio, Antonio e Cesare Arrigo	Alessandria
Italy	AORN San G.Moscati	Avellino
Italy	Centro di riferimento Oncologico - Oncologia Medica A	Aviano (PN)
Italy	Divisione di Ematologia Spedali Civili	Brescia
Italy	Ospedale di Circolo	Busto Arsizio - VA
Italy	Divisione di Ematologia Osp.Businco	Cagliari
Italy	Istituto Oncologico del Mediterraneo	Catania
Italy	Ospedale civile Divisione di Ematologia	Civitanova Marche (MC)
Italy	Ospedale S Martino	Genova
Italy	Ospedale San Martino - Divisione di Ematologia	Genova
Italy	Ospedale Santa Maria Goretti	Latina
Italy	A O Papardo	Messina
Italy	Azienda Ospedaliero Universitaria Policlinico Gaetano Martino	Messina
Italy	Ospedale dell'Angelo	Mestre	VE
Italy	Ematologia e Trapianto IRCCS, Istituto Nazionale dei Tumori	Milano
Italy	Osp. San Carlo Borromeo Divisione di Oncologia Medica	Milano
Italy	Ospedale Niguarda CA' Granda	Milano
Italy	Policlinico Maggiore	Milano
Italy	Policlinico di Modena - Università degli studi	Modena
Italy	AOU Federico II di Napoli	Napoli
Italy	Ospedale San Gennaro	Napoli
Italy	Ospedale Umberto I UO Med. Interna Oncoematologia	Nocera Inferiore (SA)
Italy	SCDU Ematologia, AOU Maggiore della Carità	Novara
Italy	A.O. di Padova Divisione di Oncologia Medica	Padova
Italy	Azienda Ospedaliera V. Cervello	Palermo
Italy	Policlinico P.Giaccone	Palermo
Italy	Fondazione Policlinico San Matteo	Pavia
Italy	Ospedale Santo Spirito Dipartimento di Ematologia	Pescara
Italy	Ospedale Civile G.da Saliceto - UOA Ematologia	Piacenza
Italy	Azienda Ospedaliera "Bianchi Melacrino Morelli"	Reggio Calabria
Italy	AO Santa Maria Nuova	Reggio Emilia
Italy	Ospedale Oncologico regionale CROB	Rionero in Vulture (PZ)
Italy	Ospedale S. Eugenio	Roma
Italy	Policlinico Università Tor Vergata	Roma
Italy	Univeristà La Sapienza	Roma
Italy	Clinica Humanitas	Rozzano (MI)
Italy	IRCCS Casa Sollievo della Sofferenza	San Giovanni Rotondo (FG)
Italy	Istituto di Ematologia Università degli studi di Sassari	Sassari
Italy	Ematologia II OspedaleSan Giovanni Battista Molinette	Torino
Italy	Presidio Ospedaliero - Unità Complessa Ematologia	Treviso

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Italiana Linfomi ONLUS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The prognostic score will be defined taking into account Overall Survival (OS).	Surviving patents will be censored at the date of last known to be alive.	4 years	No
Secondary	To evaluate the defined prognostic score in terms of Progression Free Survival (PFS)	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	4 years	No