Early Chemotherapy Intensification in Interim-Positron Emission Tomography (PET) Positive Hodgkin Lymphoma

Ospedale Santa Croce-Carle Cuneo

Status: Unknown

Conditions: Hodgkin Lymphoma

Study type: Observational

Funder types: Other

Identifiers

NCT00877747

HD-PET-intens-retr

Details and patient eligibility

About

Early interim-PET after two courses of chemotherapy is a powerful outcome predictor in advanced-stage Hodgkin Lymphoma (HL) patients treated with adriamycin (doxorubicin), bleomycin, vinblastine and dacarbazine (ABVD). Two-year Progression Free Survival of PET-2 positive patients is only 12%, but the optimal treatment for this patient subset is still unknown.

From January 2006 GITIL (Gruppo Italiano Terapie Innovative nei Linfomi) suggested an early intensification of chemotherapy with BEACOPP [Bleomycin, Etoposide, Adriamycin (doxorubicin), Cyclophosphamide, Oncovin (vincristine), Procarbazine, and Prednisone](4 escalated + 4 baseline cycles) for all the HL patients with a positive PET-2 after 2 ABVD courses. The investigators retrospectively recorded and analyzed these data in order to evaluate if this strategy could be of benefit for this subset of patients.

Enrollment: 160 patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with advanced Hodgkin's lymphoma according to the World Health Organization classification
• Age 16-80
• Not previously treated
• Stage IIB to IVB or stage IIA with adverse prognostic factors (more than 3 nodal sites, ESR > 50 mm, bulky lesion)
• Written informed consent

Exclusion criteria

• Patients aged more than 80
• Concomitant or previously treated neoplastic disorder less than 5 years before the diagnosis of Hodgkin's lymphoma
• Psychiatric disorders
• Uncontrolled infectious disease
• Impaired cardiac (EF < 50%) or renal (creatinine clearance < 60 ml/m)function
• Pregnancy and lactation
• Uncompensated diabetes mellitus and fasting glucose levels over 200 mg/dl

Trial design

160 participants in 2 patient groups

PET2 negative

Description:

Patients with negative early interim PET after 2 courses of ABVD who continued therapy with ABVD

PET2 positive

Description:

Patients with positive early interim PET after 2 courses of ABVD who changed their therapy to BEACOPP