Consolidation PET-based and Donor-based After Salvage Therapy in Patients With HL in Relapse or Refractory
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 264
- 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.
- 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
Ematologia Ospedale S. Maria delle Croci
🇮🇹Ravenna, RA, Italy
Div Ematologia A.O. Bianchi - Melacrino - Morelli
🇮🇹Reggio Calabria, RC, Italy
Ematologia Fondazione del Piemonte per l'Oncologia - IRCCS
🇮🇹Candiolo, Torino, Italy
S.C. Oncologia Medica III Osp. di Circolo
🇮🇹Busto Arsizio, Varese, 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
Istituto di Ematologia e Oncologia Medica, Policlinico S. Orsola
🇮🇹Bologna, Italy
Scroll for more (29 remaining)Dipartimento di Oncologia Medica ed Ematologia Istituto Clinico Humanitas🇮🇹Rozzano, Milano, Italy