Clinical trial NCT00879528: Consolidation PET-based and Donor-based After Salvage Therapy in Patients With HL in Relapse or Refractory
Official title: Consolidation PET-based and Donor-based After Salvage Therapy in Patients With Hodgkin Lymphoma in Relapse or Refractory
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hodgkin's Lymphoma
Keywords: Hodgkin's Lymphoma
stem cell reinfusion
Lead sponsor: Fondazione Italiana Linfomi - ETS
Sponsor class: OTHER
Collaborators: name: Istituto Clinico Humanitas
First posted: 2009-04-10
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients confirmed Hodgkin's lymphoma at refractory at first line therapy or relapse

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patients with negative PET after salvage therapy. To assess prospectively the overall survival and progression-free
timeFrame: 3 years
measure: 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
timeFrame: 3 years
Secondary outcomes:
measure: Evaluate the percentage of complete remission.
timeFrame: 3 years
measure: Evaluate the haematological toxicity and non-haematological (including acute and chronic GVHD, infections).
timeFrame: 3 years
measure: Evaluation of the chimera.
timeFrame: 3 years
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Dipartimento di Oncologia Medica ed Ematologia Istituto Clinico Humanitas
state: Milano
city: Ravenna
country: Italy
facility: Ematologia Ospedale S. Maria delle Croci
state: RA
city: Reggio Calabria
country: Italy
facility: Div Ematologia A.O. Bianchi - Melacrino - Morelli
state: RC
city: Candiolo
country: Italy
facility: Ematologia Fondazione del Piemonte per l'Oncologia - IRCCS
state: Torino
city: Busto Arsizio
country: Italy
facility: S.C. Oncologia Medica III Osp. di Circolo
state: Varese
city: Alessandria
country: Italy
facility: SC Ematologia - A.O.SS. Biagio, Antonio e Cesare Arrigo
city: Avellino
country: Italy
facility: SC Enatologia e Trapianto emopoietico AORN San G.Moscati
city: Aviano (PN)
country: Italy
facility: Centro di Riferimento Oncologico - Oncologia Medica A
city: Bari
country: Italy
facility: Azienda Ospedaliera Policlinico di Bari
city: Bologna
country: Italy
facility: Istituto di Ematologia e Oncologia Medica, Policlinico S. Orsola
city: Brescia
country: Italy
facility: Ematologia Spedali Civili
city: Brindisi
country: Italy
facility: Presidio Ospedaliero A.Perrino - Divisione di Ematologia
city: Cagliari
country: Italy
facility: Ematologia Ospedale A.Businco
city: Cuneo
country: Italy
facility: SC Ematologia ASO S. Croce e Carle
city: Firenze
country: Italy
facility: Unità funzionale di Ematologia AOU Careggi
city: Meldola (FC)
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
city: Messina
country: Italy
facility: SC Ematologia Azienda Ospedaliera Papardo Nesima
city: Milano
country: Italy
facility: Ematologia Ospedale Niguarda Cà Granda
city: Milano
country: Italy
facility: Unità Linfomi - Dipartimento Oncoematologia Istituto Scientifico S. Raffaele
city: Modena
country: Italy
facility: Centro Oncologico Modenese
city: Napoli
country: Italy
facility: AOU Federico II di Napoli
city: Novara
country: Italy
facility: SCDU Ematologia AOU Maggiore della Carità
city: Nuoro
country: Italy
facility: ASL 3 Nuoro, UOC Ematologia e CTMO HSF
city: Pavia
country: Italy
facility: Ematologia Policlinico San Matteo
city: Piacenza
country: Italy
facility: UO Ematologia Ospedale Civile G.da Saliceto
city: Rimini
country: Italy
facility: Ospedale degli Infermi - Ematologia
city: Roma
country: Italy
facility: Istituto Regina Elena IFO
city: Roma
country: Italy
facility: Univeristà La Sapienza
city: Roma
country: Italy
facility: Università Cattolica Policlinico Gemelli - Cattedra di Ematologia
city: Roma
country: Italy
facility: UOC Ematologia Ospedale S.Eugenio
city: San Giovanni Rotondo
country: Italy
facility: Casa sollievo della Sofferenza
city: Siena
country: Italy
facility: UOC Ematologia e Trapianti AO Universitaria senese
city: Terni
country: Italy
facility: SC Oncoematologia Azienda Ospedaliera S. Maria di Terni
city: Torino
country: Italy
facility: SC Ematologia Ospedale San Giovanni Battista - Molinette
city: Trani
country: Italy
facility: ASL BAT 1 Divisione di Ematologia
city: Tricase (LE)
country: Italy
facility: A.O.Cardinale Panico Ematologia e centro trapianti
city: Udine
country: Italy
facility: Clinica Ematologica ASUI Integrata di Udine
city: Varese
country: Italy
facility: Oncologia Medica Ospedale di Circolo e Fondazione Macchi
city: Verbania
country: Italy
facility: UO di Oncologia Medica e Oncoematologia ASL 14 VCO di Verbania
Study officials:
affiliation: Istituto Clinico Humanitas, Dipartimento di Oncologia e Ematologia
name: Luca Castagna, MD
role: STUDY_DIRECTOR
affiliation: Istituto Clinico Humanitas, Dipartimento di Oncologia e Ematologia
name: Armando Santoro, MD
role: STUDY_DIRECTOR
References: