Overview

Positron Emission Tomography (PET)-Adapted Chemotherapy In Advanced Hodgkin Lymphoma (HL)

Status:
Unknown status
Trial end date:
2015-10-01
Target enrollment:
0
Participant gender:
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 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ospedale Santa Croce-Carle Cuneo
Collaborators:
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