Clinical trial NCT00877747: Early Chemotherapy Intensification in Interim-Positron Emission Tomography (PET) Positive Hodgkin Lymphoma
Official title: Early Chemotherapy Intensification With BEACOPP in High-risk, Interim-PET Positive Advanced-stage Hodgkin Lymphoma:a GITIL Retrospective Multicenter Clinical Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hodgkin Lymphoma
Keywords: PET
Lead sponsor: Ospedale Santa Croce-Carle Cuneo
Sponsor class: OTHER
First posted: 2009-04-08
Enrollment: 160
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced stage Hodgkin's lymphoma (IIB to IVB) or in stage IIA with adverse prognostic factors (more than 3 nodal sites, ESR \> 50 mm, bulky lesion)

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.


Eligibility criteria: 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

Primary outcomes:
measure: Progression Free Survival
timeFrame: 2 years
Secondary outcomes:
measure: Incidence of progression/relapse
timeFrame: 2 years
measure: Interim PET positive and negative predictive value
timeFrame: 2 years
Other outcomes:
Locations:
city: Cuneo
country: Italy
facility: Azienda Ospedaliera Santa Croce e Carle
Study officials:
affiliation: Azienda Ospedaliera Santa Croce e Carle
name: Andrea Gallamini, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gallamini A, Hutchings M, Rigacci L, Specht L, Merli F, Hansen M, Patti C, Loft A, Di Raimondo F, D'Amore F, Biggi A, Vitolo U, Stelitano C, Sancetta R, Trentin L, Luminari S, Iannitto E, Viviani S, Pierri I, Levis A. Early interim 2-[18F]fluoro-2-deoxy-D-glucose positron emission tomography is prognostically superior to international prognostic score in advanced-stage Hodgkin's lymphoma: a report from a joint Italian-Danish study. J Clin Oncol. 2007 Aug 20;25(24):3746-52. doi: 10.1200/JCO.2007.11.6525. Epub 2007 Jul 23.
citation: Gallamini A, Patti C, Viviani S, Rossi A, Fiore F, Di Raimondo F, Cantonetti M, Stelitano C, Feldman T, Gavarotti P, Sorasio R, Mule A, Leone M, Rambaldi A, Biggi A, Barrington S, Fallanca F, Ficola U, Chauvie S, Gianni AM; Gruppo Italiano Terapie Innovative nei Linfomi (GITIL). Early chemotherapy intensification with BEACOPP in advanced-stage Hodgkin lymphoma patients with a interim-PET positive after two ABVD courses. Br J Haematol. 2011 Mar;152(5):551-60. doi: 10.1111/j.1365-2141.2010.08485.x. Epub 2010 Dec 20.