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Hodgkin's LymphomaIIL-ProHLRecNCT01478191

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

An observational study of Hodgkin's Lymphoma, run by Fondazione Italiana Linfomi - ETS at 40 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hodgkin's Lymphoma
How many people
495 participants
Where
40 sitesItaly
Study dates
May 2010to Jun 2011
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • NONE

Trial locations and contacts

40 sites in 1 country.

40 sites in 1 country

Italy40 sites

  • A.O.SS. Biagio, Antonio e Cesare Arrigo

    Alessandria

  • AORN San G.Moscati

    Avellino

  • Centro di riferimento Oncologico - Oncologia Medica A

    Aviano (PN)

  • Divisione di Ematologia Spedali Civili

    Brescia

  • Ospedale di Circolo

    Busto Arsizio - VA

  • Divisione di Ematologia Osp.Businco

    Cagliari

  • Istituto Oncologico del Mediterraneo

    Catania, Catania, 95029

  • Ospedale civile Divisione di Ematologia

    Civitanova Marche (MC)

  • Ospedale S Martino

    Genova

  • Ospedale San Martino - Divisione di Ematologia

    Genova

  • Ospedale Santa Maria Goretti

    Latina

  • A O Papardo

    Messina

  • Azienda Ospedaliero Universitaria Policlinico Gaetano Martino

    Messina

  • Ospedale dell'Angelo

    Mestre, VE

  • Policlinico Maggiore

    Milan, Italy, 20162

  • Ematologia e Trapianto IRCCS, Istituto Nazionale dei Tumori

    Milan, Milano

  • Osp. San Carlo Borromeo Divisione di Oncologia Medica

    Milan

  • Ospedale Niguarda CA' Granda

    Milan

  • Policlinico di Modena - Università degli studi

    Modena

  • Ospedale San Gennaro

    Naples, Italy

  • AOU Federico II di Napoli

    Naples

  • Ospedale Umberto I UO Med. Interna Oncoematologia

    Nocera Inferiore (SA)

  • SCDU Ematologia, AOU Maggiore della Carità

    Novara, Novara, 28100

  • A.O. di Padova Divisione di Oncologia Medica

    Padova

  • Azienda Ospedaliera V. Cervello

    Palermo, Italy, 90146

  • Policlinico P.Giaccone

    Palermo

  • Fondazione Policlinico San Matteo

    Pavia

  • Ospedale Santo Spirito Dipartimento di Ematologia

    Pescara

  • Ospedale Civile G.da Saliceto - UOA Ematologia

    Piacenza

  • Azienda Ospedaliera "Bianchi Melacrino Morelli"

    Reggio Calabria, Italy, 89124

  • AO Santa Maria Nuova

    Reggio Emilia

  • Ospedale Oncologico regionale CROB

    Rionero in Vulture (PZ)

  • Ospedale S. Eugenio

    Roma

  • Policlinico Università Tor Vergata

    Roma

  • Univeristà La Sapienza

    Roma

  • Clinica Humanitas

    Rozzano (MI)

  • IRCCS Casa Sollievo della Sofferenza

    San Giovanni Rotondo (FG)

  • Istituto di Ematologia Università degli studi di Sassari

    Sassari

  • Ematologia II OspedaleSan Giovanni Battista Molinette

    Torino

  • Presidio Ospedaliero - Unità Complessa Ematologia

    Treviso, Italy, 31100

Other trials in Italy

About this study

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)

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).
Keywords
Hodgkin's Lymphoma, Ifosfamide, Gemcitabine and Vinorelbine (IGEV), High Dose Chemotherapy (HDCT), Autologous Hematopoietic Stem Cells Transplantation (AHSCT)
Medical subject headings
Hodgkin Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4 years

Secondary outcomes (1)

  1. 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

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2011 (estimated)
  2. Study startMay 2010
  3. Study completionJun 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
495 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01478191
Sponsor's protocol ID
IIL-ProHLRec
Other IDs
30
Acronym
IIL-ProHLRec
Status last verified
Nov 2011
First submitted
17 Oct 2011
Last updated
6 Mar 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hodgkin's Lymphoma, run by Fondazione Italiana Linfomi - ETS at 40 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The prognostic score will be defined taking into account Overall Survival (OS). (time frame: 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01478191.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2013.

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