Hodgkin's Lymphoma
Conditions
Keywords
Hodgkin's Lymphoma, stem cell reinfusion
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.
Interventions
OTHERPatients 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.
OTHERPatients 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.
Sponsors
Istituto Clinico Humanitas
Fondazione Italiana Linfomi - ETS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Italy
Outcome results
None listed