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

Early Chemotherapy Intensification With BEACOPP in High-risk, Interim-PET Positive Advanced-stage Hodgkin Lymphoma:a GITIL Retrospective Multicenter Clinical Study

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00877747

Enrollment

160

Registered

2009-04-08

Start date

2006-01-31

Completion date

2015-10-31

Last updated

2015-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hodgkin Lymphoma

Keywords

PET

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Progression Free Survival	2 years

Secondary

Measure	Time frame
Incidence of progression/relapse	2 years
Interim PET positive and negative predictive value	2 years

Countries

Italy

Outcome results