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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
DR. ANDREA GALLAMINI, Ospedale Santa Croce-Carle Cuneo Identifier:
First received: April 7, 2009
Last updated: October 16, 2015
Last verified: October 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.

Hodgkin Lymphoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Early Chemotherapy Intensification With BEACOPP in High-risk, Interim-PET Positive Advanced-stage Hodgkin Lymphoma:a GITIL Retrospective Multicenter Clinical Study

Resource links provided by NLM:

Further study details as provided by DR. ANDREA GALLAMINI, Ospedale Santa Croce-Carle Cuneo:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Incidence of progression/relapse [ Time Frame: 2 years ]
  • Interim PET positive and negative predictive value [ Time Frame: 2 years ]

Enrollment: 160
Study Start Date: January 2006
Estimated Study Completion Date: October 2015
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
PET2 negative
Patients with negative early interim PET after 2 courses of ABVD who continued therapy with ABVD
PET2 positive
Patients with positive early interim PET after 2 courses of ABVD who changed their therapy to BEACOPP


Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

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
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Please refer to this study by its identifier: NCT00877747

Azienda Ospedaliera Santa Croce e Carle
Cuneo, Italy, 12100
Sponsors and Collaborators
Ospedale Santa Croce-Carle Cuneo
Principal Investigator: Andrea Gallamini, MD Azienda Ospedaliera Santa Croce e Carle
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: DR. ANDREA GALLAMINI, Professor, Ospedale Santa Croce-Carle Cuneo Identifier: NCT00877747     History of Changes
Other Study ID Numbers: HD-PET-intens-retr
Study First Received: April 7, 2009
Last Updated: October 16, 2015

Keywords provided by DR. ANDREA GALLAMINI, Ospedale Santa Croce-Carle Cuneo:

Additional relevant MeSH terms:
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases processed this record on May 25, 2017