NCT01399931

Brief Summary

To assess specificity and overall accuracy of interim dual-point acquisition PET in predicting treatment outcome. The study is aimed at assessing the specificity of interim dual-point PET performed after 2 ABVD cycles to predict treatment outcome in early-stage Hodgkin's Lymphoma patients presenting bulky lesions at baseline.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 22, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

October 19, 2015

Status Verified

October 1, 2015

Enrollment Period

3.8 years

First QC Date

July 21, 2011

Last Update Submit

October 16, 2015

Conditions

Hodgkin's Lymphoma

Keywords

Early stage

Outcome Measures

Primary Outcomes (1)

  • Event free survival (EFS)

    To assess feasibility of using interim dual-point acquisition PET in real world of clinical practice as well as describing the outcome of early stage HL patients.

    1 year

Secondary Outcomes (1)

  • Evaluation of inflammation markers prognostic role

    3 years

Study Arms (1)

Early-stage Hodgkin Lymphoma Patients

Early-stage Hodgkin Lymphoma (HL) patients presenting bulky nodal lesions treated with ABVD and consolidation radiotherapy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Early-stage Hodgkin Lymphoma (HL) patients presenting bulky nodal lesions.

You may qualify if:

  • Hodgkin lymphoma diagnosis according all the WHO classification subtype but lymphocyte predominance.
  • Age 18 - 60 years old
  • stage IA- IIA (by FDG-PET scan)
  • Presence of bulky tumour (either in Mediastinum or other site)
  • Treatment with ABVD x 4 (early stage)
  • Consolidation Radiotherapy on bulky lesion
  • Signed the Informed consent form

You may not qualify if:

  • Diabetes mellitus uncompensated
  • Lymphocyte predominance histology
  • Pregnancy or lactation
  • Implanted biomedical devices (for DW-MRI sub study)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Ospedale Santi Antonio E Biagio E Cesare Arrigo

Alessandria, AL, 15100, Italy

RECRUITING

Azienda Sanitaria Ospedaliera S. Croce E Carle

Cuneo, Cuneo, 12100, Italy

RECRUITING

Azienda Ospedaliera Universitaria S. Martino

Genova, GE, 16132, Italy

RECRUITING

Azienda Ospedaliera S. Gerardo

Monza, MB, 20900, Italy

RECRUITING

Azienda Ospedaliera Ospedali Riuniti Papardo Piemonte

Messina, ME, 98158, Italy

RECRUITING

Azienda Ospedaliera S. Giovanni Battista

Torino, TO, 10126, Italy

RECRUITING

Related Publications (1)

  • Gallamini A.:Positron emission tomography scanning: a new paradigm for the management of Hodgkin's lymphoma. Haematologica 2010;95, 1-3 Gallamini A, Rigacci L, Merli F, Nassi L, Bosi A, Capodanno I, et al. The predictive value of positron emission tomography scanning performed after two courses of standard therapy on treatment outcome in advanced stage Hodgkin's disease. Haematologica 2006 Apr;91(4):475-81. Meignan M, Itti E, Gallamini A, Haioun C. Interim 18F-fluorodeoxyglucose positron emission tomography in diffuse large B-cell lymphoma: qualitative or quantitative interpretation - where do we stand? Leukemia & Lymphoma 2009; 50(11) 1753-56. Gallamini A, Hutchings M, Rigacci L, Specht L, Merli F, Hansen M, et al. Early interim 2-[18F]fluoro-2-deoxy-D-glucose positron emission tomography is prognostically superior to international prognostic score in advanced-stage Hodgkin's lymphoma: a report from a joint Italian-Danish study. J Clin Oncol 2007 Aug 20;25(24):3746-52.

    BACKGROUND

MeSH Terms

Conditions

Hodgkin Disease

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Andrea Gallamini, MD

    Azienda Sanitaria Ospedaliera Santa Croce e Carle Cuneo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ANDREA GALLAMINI, MD

CONTACT

+390171642414gallamini.a@ospedale.cuneo.it

MARIA ROSARIA MENNITTO, PHARM D

CONTACT

+390171642415mennitto.m@ospedale.cuneo.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
HEAD OF HAEMATOLOGY DEPT. A.S.O. S. CROCE AND CARLE

Study Record Dates

First Submitted

July 21, 2011

First Posted

July 22, 2011

Study Start

January 1, 2012

Primary Completion

October 1, 2015

Study Completion

January 1, 2017

Last Updated

October 19, 2015

Record last verified: 2015-10

Locations

IT(6)