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

Overview

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 Title of Study: “Consolidation PET-based and Donor-based After Salvage Therapy in Patients With Hodgkin Lymphoma in Relapse or Refractory”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 2010

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

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Patients with negative PET after salvage therapy. To assess prospectively the overall survival and progression-free
    • Time Frame: 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
    • Time Frame: 3 years

Secondary Measures

  • Evaluate the percentage of complete remission.
    • Time Frame: 3 years
  • Evaluate the haematological toxicity and non-haematological (including acute and chronic GVHD, infections).
    • Time Frame: 3 years
  • Evaluation of the chimera.
    • Time Frame: 3 years

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fondazione Italiana Linfomi ONLUS
  • Collaborator
    • Istituto Clinico Humanitas
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Luca Castagna, MD, Study Director, Istituto Clinico Humanitas, Dipartimento di Oncologia e Ematologia
    • Armando Santoro, MD, Study Director, Istituto Clinico Humanitas, Dipartimento di Oncologia e Ematologia

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