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

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Key information

Conditions

Hodgkin's Lymphoma Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Oncologico del Mediterraneo, Catania, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Time frame: 4 years

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

Secondary outcomes

To evaluate the defined prognostic score in terms of Progression Free Survival (PFS)

Time frame: 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

Sponsors and collaborators

Lead sponsor

Fondazione Italiana Linfomi - ETS

Other

Registry information

Official study 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)

Acronym: IIL-ProHLRec

Important dates

Study start: 2010
Study completion: 2011
First posted: Nov 23, 2011
Registry last updated: Mar 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed