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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Ospedale Santa Croce-Carle Cuneo.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Ospedale Santa Croce-Carle Cuneo
ClinicalTrials.gov Identifier:
NCT00877747
First received: April 7, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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
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 Ospedale Santa Croce-Carle Cuneo:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of progression/relapse [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Interim PET positive and negative predictive value [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 160
Study Start Date: January 2006
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   16 Years to 80 Years
Genders Eligible for Study:   Both
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)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00877747

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andrea Gallamini, Head of Haematology Dept.
ClinicalTrials.gov Identifier: NCT00877747     History of Changes
Other Study ID Numbers: HD-PET-intens-retr
Study First Received: April 7, 2009
Last Updated: April 7, 2009
Health Authority: Italy: Ethics Committee

Keywords provided by Ospedale Santa Croce-Carle Cuneo:
PET

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on August 20, 2014