Early Chemotherapy Intensification in Interim-Positron Emission Tomography (PET) Positive Hodgkin Lymphoma
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|ClinicalTrials.gov Identifier: NCT00877747|
Recruitment Status : Unknown
Verified October 2015 by DR. ANDREA GALLAMINI, Ospedale Santa Croce-Carle Cuneo.
Recruitment status was: Active, not recruiting
First Posted : April 8, 2009
Last Update Posted : October 19, 2015
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||160 participants|
|Official Title:||Early Chemotherapy Intensification With BEACOPP in High-risk, Interim-PET Positive Advanced-stage Hodgkin Lymphoma:a GITIL Retrospective Multicenter Clinical Study|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||November 2014|
|Estimated Study Completion Date :||October 2015|
Patients with negative early interim PET after 2 courses of ABVD who continued therapy with ABVD
Patients with positive early interim PET after 2 courses of ABVD who changed their therapy to BEACOPP
- Progression Free Survival [ Time Frame: 2 years ]
- Incidence of progression/relapse [ Time Frame: 2 years ]
- Interim PET positive and negative predictive value [ Time Frame: 2 years ]
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00877747
|Azienda Ospedaliera Santa Croce e Carle|
|Cuneo, Italy, 12100|
|Principal Investigator:||Andrea Gallamini, MD||Azienda Ospedaliera Santa Croce e Carle|