Prognosis of Patients With Relapsed/Refractory Hodgkin Lymphoma Treated With IGEV Induction Therapy Before HDCT With AHSCT
IIL-ProHLRec
2 other identifiers
observational
495
1 country
40
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2010
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 17, 2011
CompletedFirst Posted
Study publicly available on registry
November 23, 2011
CompletedMarch 6, 2013
November 1, 2011
October 17, 2011
March 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
To evaluate the defined prognostic score in terms of Progression Free Survival (PFS)
4 years
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- NONE
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Istituto Oncologico del Mediterraneo
Catania, Catania, 95029, Italy
Policlinico Maggiore
Milan, Italy, 20162, Italy
Ospedale San Gennaro
Napoli, Italy, Italy
Azienda Ospedaliera V. Cervello
Palermo, Italy, 90146, Italy
Azienda Ospedaliera "Bianchi Melacrino Morelli"
Reggio Calabria, Italy, 89124, Italy
Presidio Ospedaliero - Unità Complessa Ematologia
Treviso, Italy, 31100, Italy
Ematologia e Trapianto IRCCS, Istituto Nazionale dei Tumori
Milan, Milano, Italy
SCDU Ematologia, AOU Maggiore della Carità
Novara, Novara, 28100, Italy
Ospedale dell'Angelo
Mestre, VE, 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
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
Osp. San Carlo Borromeo Divisione di Oncologia Medica
Milan, Italy
Ospedale Niguarda CA' Granda
Milan, Italy
Policlinico di Modena - Università degli studi
Modena, Italy
AOU Federico II di Napoli
Napoli, Italy
Ospedale Umberto I UO Med. Interna Oncoematologia
Nocera Inferiore (SA), Italy
A.O. di Padova Divisione di Oncologia Medica
Padua, 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
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Armando Santoro, Prof.
Istituto Clinico Humanitas
- PRINCIPAL INVESTIGATOR
Monica Balzarotti, Dr.
Istituto Clinico Humanitas
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2011
First Posted
November 23, 2011
Study Start
May 1, 2010
Study Completion
June 1, 2011
Last Updated
March 6, 2013
Record last verified: 2011-11