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

Fondazione Italiana Linfomi - ETS

Status: Terminated

Conditions: Hodgkin's Lymphoma

Treatments: Other: Patients with negative PET after salvage therapy; Other: Patients with positive PET after salvage therapy

Study type: Observational

Funder types: Other

Identifiers

NCT00879528

IIL-HD0802

Details and patient eligibility

About

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.

Full 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.

Enrollment: 264 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.