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

October 17, 2011
March 5, 2013
May 2010
Not Provided
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.
Same as current
Complete list of historical versions of study NCT01478191 on ClinicalTrials.gov Archive Site
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
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 CR response rate in terms of ORR To validate the prognostic scores in terms of PFS and in terms OS
Not Provided
Not Provided
 
Prognosis of Patients With Relapsed/Refractory Hodgkin Lymphoma Treated With IGEV Induction Therapy Before HDCT With AHSCT
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).
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample

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.

Hodgkin's Lymphoma
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
495
June 2011
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01478191
IIL-ProHLRec, 30
No
Fondazione Italiana Linfomi ONLUS
Fondazione Italiana Linfomi ONLUS
Not Provided
Principal Investigator: Armando Santoro, Prof. Istituto Clinico Humanitas
Principal Investigator: Monica Balzarotti, Dr. Istituto Clinico Humanitas
Fondazione Italiana Linfomi ONLUS
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP