Status:
TERMINATED
Consolidation PET-based and Donor-based After Salvage Therapy in Patients With HL in Relapse or Refractory
Lead Sponsor:
Fondazione Italiana Linfomi - ETS
Collaborating Sponsors:
Istituto Clinico Humanitas
Conditions:
Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
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 d...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
264 Patients enrolled
Trial Details
Trial ID
NCT00879528
Start Date
May 1 2009
End Date
September 1 2015
Last Update
August 17 2016
Active Locations (39)
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1
Istituto di Ematologia e Oncologia Medica, Policlinico S. Orsola
Bologna, Bologna, Italy, 40138
2
Unità funzionale di Ematologia AOU Careggi
Florence, Firenze, Italy, 50139
3
Dipartimento di Oncologia Medica ed Ematologia Istituto Clinico Humanitas
Rozzano, Milano, Italy
4
Ematologia Policlinico San Matteo
Pavia, Pavia, Italy, 27100