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

Terminated

• Conditions: Hodgkin's Lymphoma

• Registration Number: NCT00879528
• Lead Sponsor: Fondazione Italiana Linfomi - ETS

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.

Study Timeline

• Study First Submitted: 2009-04-09
• Study First Submitted QC: 2009-04-09
• Study First Posted: 2009-04-10
• Study Start: 2009-05
• Primary Completion: 2010-05
• Study Completion: 2015-09
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-16
• Last Update Posted: 2016-08-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 264

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (39)

Dipartimento di Oncologia Medica ed Ematologia Istituto Clinico Humanitas; 🇮🇹 Rozzano, Milano, Italy

Div Ematologia A.O. Bianchi - Melacrino - Morelli; 🇮🇹 Reggio Calabria, RC, Italy

Ematologia Fondazione del Piemonte per l'Oncologia - IRCCS; 🇮🇹 Candiolo, Torino, Italy

SC Ematologia - A.O.SS. Biagio, Antonio e Cesare Arrigo; 🇮🇹 Alessandria, Italy

Centro di Riferimento Oncologico - Oncologia Medica A; 🇮🇹 Aviano (PN), Italy

SC Enatologia e Trapianto emopoietico AORN San G.Moscati; 🇮🇹 Avellino, Italy

Azienda Ospedaliera Policlinico di Bari; 🇮🇹 Bari, Italy

Istituto di Ematologia e Oncologia Medica, Policlinico S. Orsola; 🇮🇹 Bologna, Italy

Presidio Ospedaliero A.Perrino - Divisione di Ematologia; 🇮🇹 Brindisi, Italy

Ematologia Spedali Civili; 🇮🇹 Brescia, Italy

Ematologia Ospedale A.Businco; 🇮🇹 Cagliari, Italy

SC Ematologia ASO S. Croce e Carle; 🇮🇹 Cuneo, Italy

Unità funzionale di Ematologia AOU Careggi; 🇮🇹 Firenze, 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; 🇮🇹 Milano, Italy

Unità Linfomi - Dipartimento Oncoematologia Istituto Scientifico S. Raffaele; 🇮🇹 Milano, 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, Italy

Ematologia Policlinico San Matteo; 🇮🇹 Pavia, Italy

UO Ematologia Ospedale Civile G.da Saliceto; 🇮🇹 Piacenza, Italy

Istituto Regina Elena IFO; 🇮🇹 Roma, Italy

Ospedale degli Infermi - Ematologia; 🇮🇹 Rimini, 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, Italy

UO di Oncologia Medica e Oncoematologia ASL 14 VCO di Verbania; 🇮🇹 Verbania, Italy

S.C. Oncologia Medica III Osp. di Circolo; 🇮🇹 Busto Arsizio, Varese, Italy

Ematologia Ospedale S. Maria delle Croci; 🇮🇹 Ravenna, RA, Italy