Consolidation PET-based and Donor-based After Salvage Therapy in Patients With HL in Relapse or Refractory

August 16, 2016 updated by: Fondazione Italiana Linfomi ONLUS

Consolidation PET-based and Donor-based After Salvage Therapy in Patients With Hodgkin Lymphoma in Relapse or Refractory

PET-based consolidation and donor-based therapy after rescue in patients with Hodgkin's lymphoma refractory at first line therapy, or relapse early or late, undergone a second line chemotherapy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a prospective observational study in which patients with positive PET scan after salvage therapy are candidates to a sequential scheme "auto-allotransplantation" in case of availability of a donor . In the event of unavailability of a donor , the same patients are candidates for a double high-dose chemotherapy with autologous stem cell support.

Study Type

Observational

Enrollment (Actual)

264

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Alessandria, Italy
        • SC Ematologia - A.O.SS. Biagio, Antonio e Cesare Arrigo
      • Avellino, Italy
        • SC Enatologia e Trapianto emopoietico AORN San G.Moscati
      • Aviano (PN), Italy
        • Centro di riferimento Oncologico - Oncologia Medica A
      • Bari, Italy
        • Azienda Ospedaliera Policlinico Di Bari
      • Bologna, Italy, 40138
        • Istituto di Ematologia e Oncologia Medica, Policlinico S. Orsola
      • Brescia, Italy
        • Ematologia Spedali Civili
      • Brindisi, Italy
        • Presidio Ospedaliero A.Perrino - Divisione di Ematologia
      • Cagliari, Italy
        • Ematologia Ospedale A.Businco
      • Cuneo, Italy, 12100
        • SC Ematologia ASO S. Croce e Carle
      • Firenze, Italy, 50139
        • Unità Funzionale di Ematologia AOU Careggi
      • Meldola (FC), Italy
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
      • Messina, Italy
        • SC Ematologia Azienda Ospedaliera Papardo Nesima
      • Milano, Italy
        • Ematologia Ospedale Niguarda Cà Granda
      • Milano, Italy
        • Unità Linfomi - Dipartimento Oncoematologia Istituto Scientifico S. Raffaele
      • Modena, Italy
        • Centro Oncologico Modenese
      • Napoli, Italy
        • AOU Federico II di Napoli
      • Novara, Italy
        • SCDU Ematologia AOU Maggiore della Carità
      • Nuoro, Italy, 08100
        • ASL 3 Nuoro, UOC Ematologia e CTMO HSF
      • Pavia, Italy, 27100
        • Ematologia Policlinico San Matteo
      • Piacenza, Italy
        • UO Ematologia Ospedale Civile G.da Saliceto
      • Rimini, Italy
        • Ospedale degli Infermi - Ematologia
      • Roma, Italy
        • Univeristà La Sapienza
      • Roma, Italy
        • Istituto Regina Elena IFO
      • Roma, Italy
        • Università Cattolica Policlinico Gemelli - Cattedra di Ematologia
      • Roma, Italy
        • UOC Ematologia Ospedale S.Eugenio
      • San Giovanni Rotondo, Italy
        • Casa Sollievo della Sofferenza
      • Siena, Italy
        • UOC Ematologia e Trapianti AO Universitaria senese
      • Terni, Italy
        • SC Oncoematologia Azienda Ospedaliera S. Maria di Terni
      • Torino, Italy
        • SC Ematologia Ospedale San Giovanni Battista - Molinette
      • Trani, Italy
        • ASL BAT 1 Divisione di Ematologia
      • Tricase (LE), Italy
        • A.O.Cardinale Panico Ematologia e centro trapianti
      • Udine, Italy
        • Clinica Ematologica ASUI Integrata di Udine
      • Varese, Italy, 21100
        • Oncologia Medica Ospedale di Circolo e Fondazione Macchi
      • Verbania, Italy, 28900
        • UO di Oncologia Medica e Oncoematologia ASL 14 VCO di Verbania
    • Milano
      • Rozzano, Milano, Italy
        • Dipartimento di Oncologia Medica ed Ematologia Istituto Clinico Humanitas
    • RA
      • Ravenna, RA, Italy, 48100
        • Ematologia Ospedale S. Maria delle Croci
    • RC
      • Reggio Calabria, RC, Italy, 89125
        • Div Ematologia A.O. Bianchi - Melacrino - Morelli
    • Torino
      • Candiolo, Torino, Italy, 10060
        • Ematologia Fondazione del Piemonte per l'Oncologia - IRCCS
    • Varese
      • Busto Arsizio, Varese, Italy, 21052
        • S.C. Oncologia Medica III Osp. di Circolo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients confirmed Hodgkin's lymphoma at refractory at first line therapy or relapse

Description

Inclusion Criteria:

  • Patients confirmed Hodgkin's lymphoma at refractory at first line therapy, relapse early or late;
  • Age > 18 years;
  • Life expectancy > 3 months;
  • Cardiac, pulmonary, renal and liver functions with normal range;
  • Written informed consent.

Exclusion Criteria:

  • Any psychological, familiar or geographical conditions that could potentially hinder the compliance to the protocol;
  • renal failure as creatinine> 1.2 mg/dl or creatinine clearance <60 ml/min;
  • AST/ALT or bilirubin> 2.5 times the norm;
  • HCV positivity with signs of ongoing viral replication (HCV PCR + AST>1.5-2x normal);
  • Heart disease clinically significant: eg. severe hypertension not controlled, multifocal uncontrolled cardiac arrhythmias, symptomatic ischemic heart disease or congestive heart failure class NYHA class III-IV (Annex 2), previous acute myocardial infarction;
  • Ventricular ejection fraction <45%;
  • decompensated diabetes mellitus not controlled by insulin therapy; Disease with significant pulmonary function defined as FEV1 <65% of predicted or DLCO <50% of predicted value;
  • HIV positive patients;
  • Patients with uncontrolled infection;
  • Neoplasia in the last 3 years except carcinoma in situ uterus, neck and basal skin cancer or prostate cancer in early stage localized exeresi treated with surgery or brachytherapy with curative intent, a good prognosis DCIS breast treated with surgery alone;
  • Drug addiction or alcoholism.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patients with negative PET after salvage therapy. To assess prospectively the overall survival and progression-free
Time Frame: 3 years
3 years
Patients with positive PET after salvage therapy. Evaluate the role of allogeneic transplantation in these patients after salvage chemotherapy and compare the results with those obtained by 2 cycles of high dose chemotherapy with stem cell
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate the percentage of complete remission.
Time Frame: 3 years
3 years
Evaluate the haematological toxicity and non-haematological (including acute and chronic GVHD, infections).
Time Frame: 3 years
3 years
Evaluation of the chimera.
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Italiana Linfomi ONLUS

Collaborators

Istituto Clinico Humanitas

Investigators

  • Study Director: Luca Castagna, MD, Istituto Clinico Humanitas, Dipartimento di Oncologia e Ematologia
  • Study Director: Armando Santoro, MD, Istituto Clinico Humanitas, Dipartimento di Oncologia e Ematologia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

April 9, 2009

First Submitted That Met QC Criteria

April 9, 2009

First Posted (Estimate)

April 10, 2009

Study Record Updates

Last Update Posted (Estimate)

August 17, 2016

Last Update Submitted That Met QC Criteria

August 16, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIL-HD0802

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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