Hodgkin's LymphomaNCT00879528
Consolidation PET-based and Donor-based After Salvage Therapy in Patients With HL in Relapse or Refractory
An observational study of Hodgkin's Lymphoma, run by Fondazione Italiana Linfomi - ETS at 39 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin's Lymphoma
- What is being tested?
- Patients with negative PET after salvage therapy and Patients with positive PET after salvage therapy
- How many people
- 264 participants
- Where
- 39 sitesItaly
- Study dates
- May 2009to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients confirmed Hodgkin's lymphoma at refractory at first line therapy or relapse
Who may be able to join
- 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.
Who cannot join
- 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%;
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- 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.
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
Italy39 sites
SC Ematologia - A.O.SS. Biagio, Antonio e Cesare Arrigo
Alessandria
SC Enatologia e Trapianto emopoietico AORN San G.Moscati
Avellino
Centro di Riferimento Oncologico - Oncologia Medica A
Aviano (PN)
Azienda Ospedaliera Policlinico di Bari
Bari
Istituto di Ematologia e Oncologia Medica, Policlinico S. Orsola
Bologna, Bologna, 40138
Ematologia Spedali Civili
Brescia
Presidio Ospedaliero A.Perrino - Divisione di Ematologia
Brindisi
S.C. Oncologia Medica III Osp. di Circolo
Busto Arsizio, Varese, 21052
Ematologia Ospedale A.Businco
Cagliari
Ematologia Fondazione del Piemonte per l'Oncologia - IRCCS
Candiolo, Torino, 10060
SC Ematologia ASO S. Croce e Carle
Cuneo, 12100
Unità funzionale di Ematologia AOU Careggi
Florence, Firenze, 50139
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
Meldola (FC)
SC Ematologia Azienda Ospedaliera Papardo Nesima
Messina
Ematologia Ospedale Niguarda Cà Granda
Milan
Unità Linfomi - Dipartimento Oncoematologia Istituto Scientifico S. Raffaele
Milan
Centro Oncologico Modenese
Modena
AOU Federico II di Napoli
Naples
SCDU Ematologia AOU Maggiore della Carità
Novara
ASL 3 Nuoro, UOC Ematologia e CTMO HSF
Nuoro, 08100
Ematologia Policlinico San Matteo
Pavia, Pavia, 27100
UO Ematologia Ospedale Civile G.da Saliceto
Piacenza
Ematologia Ospedale S. Maria delle Croci
Ravenna, RA, 48100
Div Ematologia A.O. Bianchi - Melacrino - Morelli
Reggio Calabria, RC, 89125
Ospedale degli Infermi - Ematologia
Rimini
Istituto Regina Elena IFO
Roma
Univeristà La Sapienza
Roma
Università Cattolica Policlinico Gemelli - Cattedra di Ematologia
Roma
UOC Ematologia Ospedale S.Eugenio
Roma
Dipartimento di Oncologia Medica ed Ematologia Istituto Clinico Humanitas
Rozzano, Milano
Casa sollievo della Sofferenza
San Giovanni Rotondo
UOC Ematologia e Trapianti AO Universitaria senese
Siena
SC Oncoematologia Azienda Ospedaliera S. Maria di Terni
Terni
SC Ematologia Ospedale San Giovanni Battista - Molinette
Torino
ASL BAT 1 Divisione di Ematologia
Trani
A.O.Cardinale Panico Ematologia e centro trapianti
Tricase (LE)
Clinica Ematologica ASUI Integrata di Udine
Udine
Oncologia Medica Ospedale di Circolo e Fondazione Macchi
Varese, 21100
UO di Oncologia Medica e Oncoematologia ASL 14 VCO di Verbania
Verbania, Verbania, 28900
About this study
Official title: 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.
Read the 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.
- Conditions
- Hodgkin's Lymphoma
- Being tested
- Patients with negative PET after salvage therapy, Patients with positive PET after salvage therapy
- Keywords
- Hodgkin's Lymphoma, stem cell reinfusion
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with negative PET after salvage therapyOther
All patients included in the study will treat with a salvage scheme according to each center.
After the end of salvage therapy, consolidation depends on the outcome of PET:
PET negative: These patients will follow a standard treatment that includes high-dose chemotherapy with reinfusion of autologous peripheral stem cells.
Patients with positive PET after salvage therapyOther
All patients included in the study will treat with a salvage scheme according to each center.
After the end of salvage therapy, consolidation depends on the outcome of PET
PET positive, the consolidation therapy consists of 2 phases:
- phase1:common to all consists in a series of high-dose chemotherapy with Melphalan 200 mg/sqm, followed by reinfusion of autologous peripheral stem cells
- phase2:depends on the availability of a compatible donor. If there is a donor, the patient will continue with an allogeneic transplant preceded by a reduced intensity conditioning.
If there is not a donor, the patient will continue with a second round of high-dose chemotherapy with BEAM with reinfusion of autologous peripheral stem cells.
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients with negative PET after salvage therapy. To assess prospectively the overall survival and progression-free
Measured: 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
Measured: 3 years
Secondary outcomes (3)
Evaluate the percentage of complete remission.
Measured: 3 years
Evaluate the haematological toxicity and non-haematological (including acute and chronic GVHD, infections).
Measured: 3 years
Evaluation of the chimera.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2010
- Study completionSep 2015
Why it stopped: Failure of accrual achievement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin's LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Italiana Linfomi - ETS
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Clinico Humanitas
- Responsible party
- Sponsor
- Investigators
- Luca Castagna, MD, Study director, Istituto Clinico Humanitas, Dipartimento di Oncologia e EmatologiaArmando Santoro, MD, Study director, Istituto Clinico Humanitas, Dipartimento di Oncologia e Ematologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00879528
- Sponsor's protocol ID
- IIL-HD0802
- Status last verified
- Aug 2016
- First submitted
- 9 Apr 2009
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consolidation PET-based and Donor-based After Salvage Therapy in Patients With Hodgkin Lymphoma in Relapse or Refractory
- ClinicalTrials.gov ID
- NCT00879528
- Acronym / sponsor ID
- IIL-HD0802
- Conditions
- Hodgkin's Lymphoma
- Keywords
- Hodgkin's Lymphoma, stem cell reinfusion
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Failure of accrual achievement
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Fondazione Italiana Linfomi - ETSUniversity, hospital or other
- Collaborators
- Istituto Clinico Humanitas
- Study start
- May 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 10 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients confirmed Hodgkin's lymphoma at refractory at first line therapy or relapse
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients with negative PET after salvage therapyAll patients included in the study will treat with a salvage scheme according to each center. After the end of salvage therapy, consolidation depends on the outcome of PET: PET negative: These patients will follow a standard treatment that includes high-dose chemotherapy with reinfusion of autologous peripheral stem cells. | Other | – |
| Patients with positive PET after salvage therapyAll patients included in the study will treat with a salvage scheme according to each center. After the end of salvage therapy, consolidation depends on the outcome of PET PET positive, the consolidation therapy consists of 2 phases: * phase1:common to all consists in a series of high-dose chemotherapy with Melphalan 200 mg/sqm, followed by reinfusion of autologous peripheral stem cells * phase2:depends on the availability of a compatible donor. If there is a donor, the patient will continue with an allogeneic transplant preceded by a reduced intensity conditioning. If there is not a donor, the patient will continue with a second round of high-dose chemotherapy with BEAM with reinfusion of autologous peripheral stem cells. | Other | – |
Primary outcome
Patients with negative PET after salvage therapy. To assess prospectively the overall survival and progression-free
Time frame: 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 secondary outcomes
Evaluate the percentage of complete remission.
Time frame: 3 years
Evaluate the haematological toxicity and non-haematological (including acute and chronic GVHD, infections).
Time frame: 3 years
Evaluation of the chimera.
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Failure of accrual achievement). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luca Castagna, MD study director
Istituto Clinico Humanitas, Dipartimento di Oncologia e Ematologia
Armando Santoro, MD study director
Istituto Clinico Humanitas, Dipartimento di Oncologia e Ematologia
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hodgkin's Lymphoma, run by Fondazione Italiana Linfomi - ETS at 39 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Failure of accrual achievement). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients with negative PET after salvage therapy. To assess prospectively the overall survival and progression-free (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2016.