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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01478191

Acronym

IIL-ProHLRec

Enrollment

495

Registered

2011-11-23

Start date

2010-05-31

Completion date

2011-06-30

Last updated

2013-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hodgkin's Lymphoma

Keywords

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

Brief 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. 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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The prognostic score will be defined taking into account Overall Survival (OS).	4 years	Surviving patents will be censored at the date of last known to be alive.

Secondary

Measure	Time frame	Description
To evaluate the defined prognostic score in terms of Progression Free Survival (PFS)	4 years	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

Countries

Italy

Outcome results