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

O

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems