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:
Fondazione Italiana Linfomi ONLUS
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
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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:
- 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 |
|---|
|
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:
Drug Information available for:
Ifosfamide
Vinorelbine
Gemcitabine
Gemcitabine hydrochloride
Vinorelbine tartrate
U.S. FDA Resources
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
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 May 16, 2013