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

October 16, 2015 updated by: DR. ANDREA GALLAMINI, Ospedale Santa Croce-Carle Cuneo

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Actual)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Cuneo, Italy, 12100
        • Azienda Ospedaliera Santa Croce e Carle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of progression/relapse
Time Frame: 2 years
2 years
Interim PET positive and negative predictive value
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale Santa Croce-Carle Cuneo

Investigators

  • Principal Investigator: Andrea Gallamini, MD, Azienda Ospedaliera Santa Croce e Carle

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

November 1, 2014

Study Completion (Anticipated)

October 1, 2015

Study Registration Dates

First Submitted

April 7, 2009

First Submitted That Met QC Criteria

April 7, 2009

First Posted (Estimate)

April 8, 2009

Study Record Updates

Last Update Posted (Estimate)

October 19, 2015

Last Update Submitted That Met QC Criteria

October 16, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HD-PET-intens-retr

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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