Overview
Positron Emission Tomography (PET)-Adapted Chemotherapy In Advanced Hodgkin Lymphoma (HL)
Status:
Unknown status
Unknown status
Trial end date:
2015-10-01
2015-10-01
Target enrollment:
0
0
Participant gender:
All
All
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 Lymphoma patients, defined as PET-positive after two courses of conventional adriamycin (doxorubicin), bleomycin, vinblastine and dacarbazine (ABVD) chemotherapy.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Ospedale Santa Croce-Carle CuneoCollaborators:
Consorzio Mario Negri Sud
GITIL (GRUPPO ITALIANO TERAPIE INNOVATIVE NEI LINFOMI)Treatments:
Doxorubicin
Liposomal doxorubicin
Procarbazine
Vincristine
Criteria
Inclusion Criteria:- 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 Criteria:
- 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