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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)


N/A
18 Years
N/A
Not Enrolling
Both
Hodgkin's Lymphoma

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Trial Information

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)


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

Outcome Measure:

The prognostic score will be defined taking into account Overall Survival (OS).

Outcome Description:

Surviving patents will be censored at the date of last known to be alive.

Outcome Time Frame:

4 years

Safety Issue:

No

Principal Investigator

Armando Santoro, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Istituto Clinico Humanitas

Authority:

Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Study ID:

IIL-ProHLRec

NCT ID:

NCT01478191

Start Date:

May 2010

Completion Date:

June 2011

Related Keywords:

  • Hodgkin's Lymphoma
  • Hodgkin's Lymphoma
  • Ifosfamide, Gemcitabine and Vinorelbine (IGEV)
  • High Dose Chemotherapy (HDCT)
  • Autologous Hematopoietic Stem Cells Transplantation (AHSCT)
  • Hodgkin Disease
  • Lymphoma

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