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

18 Years
Open (Enrolling)
Hodgkin's Lymphoma

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Trial Information

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

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

- 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

- Drug addiction or alcoholism.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Patients with negative PET after salvage therapy. To assess prospectively the overall survival and progression-free

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Luca Castagna, MD

Investigator Role:

Study Director

Investigator Affiliation:

Istituto Clinico Humanitas, Dipartimento di Oncologia e Ematologia


Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Study ID:




Start Date:

May 2009

Completion Date:

May 2012

Related Keywords:

  • Hodgkin's Lymphoma
  • Hodgkin's Lymphoma
  • stem cell reinfusion
  • Hodgkin Disease
  • Lymphoma