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

Completed

• Conditions: Hodgkin's Lymphoma

• Registration Number: NCT01478191
• Lead Sponsor: Fondazione Italiana Linfomi - ETS

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study Completion: 2011-06
• Study First Submitted: 2011-10-17
• Status Verified: 2011-11
• Study First Submitted QC: 2011-11-22
• Study First Posted: 2011-11-23
• Last Update Submitted: 2013-03-05
• Last Update Posted: 2013-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 495

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (40)

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

Ospedale civile Divisione di Ematologia; 🇮🇹 Civitanova Marche (MC), Italy

Ospedale S Martino; 🇮🇹 Genova, Italy

Scroll for more (30 remaining)