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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fondazione Italiana Linfomi ONLUS
ClinicalTrials.gov Identifier:
NCT01478191
First received: October 17, 2011
Last updated: March 5, 2013
Last verified: November 2011
  Purpose

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).

Condition
Hodgkin's Lymphoma

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Fondazione Italiana Linfomi ONLUS:

Primary Outcome Measures:
  • The prognostic score will be defined taking into account Overall Survival (OS). [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    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) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 495
Study Start Date: May 2010
Study Completion Date: June 2011
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01478191

Locations
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
Istituto Oncologico del Mediterraneo
Catania, Italy, 95029
Ospedale civile Divisione di Ematologia
Civitanova Marche (MC), Italy
Ospedale San Martino - Divisione di Ematologia
Genova, Italy
Ospedale S Martino
Genova, Italy
Ospedale Santa Maria Goretti
Latina, Italy
A O Papardo
Messina, Italy
Azienda Ospedaliero Universitaria Policlinico Gaetano Martino
Messina, Italy
Policlinico Maggiore
Milano, Italy, 20162
Osp. San Carlo Borromeo Divisione di Oncologia Medica
Milano, Italy
Ematologia e Trapianto IRCCS, Istituto Nazionale dei Tumori
Milano, Italy
Ospedale Niguarda CA' Granda
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, 28100
A.O. di Padova Divisione di Oncologia Medica
Padova, Italy
Policlinico P.Giaccone
Palermo, Italy
Azienda Ospedaliera V. Cervello
Palermo, Italy, 90146
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, 89124
AO Santa Maria Nuova
Reggio Emilia, Italy
Ospedale Oncologico regionale CROB
Rionero in Vulture (PZ), Italy
Univeristà La Sapienza
Roma, Italy
Policlinico Università Tor Vergata
Roma, Italy
Ospedale S. Eugenio
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, Italy, 31100
Sponsors and Collaborators
Fondazione Italiana Linfomi ONLUS
Investigators
Principal Investigator: Armando Santoro, Prof. Istituto Clinico Humanitas
Principal Investigator: Monica Balzarotti, Dr. Istituto Clinico Humanitas
  More Information

No publications provided

Responsible Party: Fondazione Italiana Linfomi ONLUS
ClinicalTrials.gov Identifier: NCT01478191     History of Changes
Other Study ID Numbers: IIL-ProHLRec, 30
Study First Received: October 17, 2011
Last Updated: March 5, 2013
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Fondazione Italiana Linfomi ONLUS:
Hodgkin's Lymphoma
Ifosfamide, Gemcitabine and Vinorelbine (IGEV)
High Dose Chemotherapy (HDCT)
Autologous Hematopoietic Stem Cells Transplantation (AHSCT)

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Ifosfamide
Gemcitabine
Vinorelbine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on August 20, 2014