Status:
UNKNOWN
Positron Emission Tomography (PET)-Adapted Chemotherapy In Advanced Hodgkin Lymphoma (HL)
Lead Sponsor:
Ospedale Santa Croce-Carle Cuneo
Collaborating Sponsors:
GITIL (GRUPPO ITALIANO TERAPIE INNOVATIVE NEI LINFOMI)
Consorzio Mario Negri Sud
Conditions:
HODGKIN LYMPHOMA
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
The purpose of this multicenter clinical trial is to assess the clinical impact of dose intensification performed very early during treatment in a subset of poor prognosis, advanced-stage Hodgkin Lymp...
Detailed Description
Version number 1.0 Date 07.05.0808 Study Title A phase-II clinical trial for assessing the clinical impact of a global strategy utilizing early FDG-PET imaging for a risk-adapted therapy in untreate...
Eligibility Criteria
Inclusion
- Patients with advanced classical Hodgkin Lymphoma according to the World Health Organization classification
- Aged 18-60
- Not previously treated
- Stages IIB to IV B
- All IPS prognostic groups
- Patients who have signed an informed consent form
Exclusion
- Patients aged more than 60.
- Concomitant or previously treated neoplastic disorder less than 5 year before the diagnosis of Hodgkin's lymphoma.
- Psychiatric disorders
- Uncontrolled infectious disease
- Impaired cardiac (EF \< 50%) , renal (creatinine clearance \< 60 ml/m)
- HIV, HBV DNA, HCV RNA positive markers
- Pregnancy and lactation
- Patients with uncompensated diabetes mellitus and fasting glucose levels over 200 mg/dl
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2015
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT00795613
Start Date
June 1 2008
End Date
October 1 2015
Last Update
October 19 2015
Active Locations (24)
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1
The Chaim Sheba Medical Center
Tel Litwinsky, Israel
2
Ospedale S. Gerardo
Monza, Milano, Italy, 20052
3
A.O. Universitaria S. Luigi Gonzaga
Orbassano, Torino, Italy, 10043
4
A.O. Universitaria Ospedali Riuniti Osp. Umberto I
Ancona, Italy, 60100