Study Stopped
Failure of accrual achievement
Consolidation PET-based and Donor-based After Salvage Therapy in Patients With HL in Relapse or Refractory
1 other identifier
observational
264
1 country
39
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2009
Longer than P75 for all trials
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2009
CompletedFirst Posted
Study publicly available on registry
April 10, 2009
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedAugust 17, 2016
August 1, 2016
1 year
April 9, 2009
August 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Patients with negative PET after salvage therapy. To assess prospectively the overall survival and progression-free
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
3 years
Secondary Outcomes (3)
Evaluate the percentage of complete remission.
3 years
Evaluate the haematological toxicity and non-haematological (including acute and chronic GVHD, infections).
3 years
Evaluation of the chimera.
3 years
Interventions
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.
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.
Eligibility Criteria
Patients confirmed Hodgkin's lymphoma at refractory at first line therapy or relapse
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fondazione Italiana Linfomi - ETSlead
- Istituto Clinico Humanitascollaborator
Study Sites (39)
Istituto di Ematologia e Oncologia Medica, Policlinico S. Orsola
Bologna, Bologna, 40138, Italy
Unità funzionale di Ematologia AOU Careggi
Florence, Firenze, 50139, Italy
Dipartimento di Oncologia Medica ed Ematologia Istituto Clinico Humanitas
Rozzano, Milano, Italy
Ematologia Policlinico San Matteo
Pavia, Pavia, 27100, Italy
Ematologia Ospedale S. Maria delle Croci
Ravenna, RA, 48100, Italy
Div Ematologia A.O. Bianchi - Melacrino - Morelli
Reggio Calabria, RC, 89125, Italy
Ematologia Fondazione del Piemonte per l'Oncologia - IRCCS
Candiolo, Torino, 10060, Italy
S.C. Oncologia Medica III Osp. di Circolo
Busto Arsizio, Varese, 21052, Italy
UO di Oncologia Medica e Oncoematologia ASL 14 VCO di Verbania
Verbania, Verbania, 28900, Italy
SC Ematologia - A.O.SS. Biagio, Antonio e Cesare Arrigo
Alessandria, Italy
SC Enatologia e Trapianto emopoietico AORN San G.Moscati
Avellino, Italy
Centro di Riferimento Oncologico - Oncologia Medica A
Aviano (PN), Italy
Azienda Ospedaliera Policlinico di Bari
Bari, Italy
Ematologia Spedali Civili
Brescia, Italy
Presidio Ospedaliero A.Perrino - Divisione di Ematologia
Brindisi, Italy
Ematologia Ospedale A.Businco
Cagliari, Italy
SC Ematologia ASO S. Croce e Carle
Cuneo, 12100, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
Meldola (FC), Italy
SC Ematologia Azienda Ospedaliera Papardo Nesima
Messina, Italy
Ematologia Ospedale Niguarda Cà Granda
Milan, Italy
Unità Linfomi - Dipartimento Oncoematologia Istituto Scientifico S. Raffaele
Milan, Italy
Centro Oncologico Modenese
Modena, Italy
AOU Federico II di Napoli
Napoli, Italy
SCDU Ematologia AOU Maggiore della Carità
Novara, Italy
ASL 3 Nuoro, UOC Ematologia e CTMO HSF
Nuoro, 08100, Italy
UO Ematologia Ospedale Civile G.da Saliceto
Piacenza, Italy
Ospedale degli Infermi - Ematologia
Rimini, Italy
Istituto Regina Elena IFO
Roma, Italy
Univeristà La Sapienza
Roma, Italy
Università Cattolica Policlinico Gemelli - Cattedra di Ematologia
Roma, Italy
UOC Ematologia Ospedale S.Eugenio
Roma, Italy
Casa sollievo della Sofferenza
San Giovanni Rotondo, Italy
UOC Ematologia e Trapianti AO Universitaria senese
Siena, Italy
SC Oncoematologia Azienda Ospedaliera S. Maria di Terni
Terni, Italy
SC Ematologia Ospedale San Giovanni Battista - Molinette
Torino, Italy
ASL BAT 1 Divisione di Ematologia
Trani, Italy
A.O.Cardinale Panico Ematologia e centro trapianti
Tricase (LE), Italy
Clinica Ematologica ASUI Integrata di Udine
Udine, Italy
Oncologia Medica Ospedale di Circolo e Fondazione Macchi
Varese, 21100, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2009
First Posted
April 10, 2009
Study Start
May 1, 2009
Primary Completion
May 1, 2010
Study Completion
September 1, 2015
Last Updated
August 17, 2016
Record last verified: 2016-08