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

Hodgkin Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00877747
• Other study ID #: HD-PET-intens-retr
• Status: Active, not recruiting
• Phase: N/A
• First received: April 7, 2009
• Last updated: October 16, 2015
• Start date: January 2006
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Ospedale Santa Croce-Carle Cuneo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: October 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Santa Croce e Carle	Cuneo

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Santa Croce-Carle Cuneo

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. Epub 2007 Jul 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival		2 years	No
Secondary	Incidence of progression/relapse		2 years	No
Secondary	Interim PET positive and negative predictive value		2 years	No