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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione Italiana Linfomi ONLUS

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Istituto Clinico Humanitas

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 9, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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