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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Consolidation PET-based and Donor-based After Salvage Therapy in Patients With Hodgkin Lymphoma in Relapse or Refractory

Conditions
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Hodgkin's Lymphoma

Intervention / Treatment
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* Other: Patients with negative PET after salvage therapy
* Other: Patients with positive PET after salvage therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Patients with negative PET after salvage therapy|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.|
|Other: Patients with positive PET after salvage therapy|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hodgkin's Lymphoma, stem cell reinfusion