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Positron Emission Tomography (PET)-Adapted Chemotherapy In Advanced Hodgkin Lymphoma (HL) (HD0607)

This study is currently recruiting participants.
Verified February 2012 by Ospedale Santa Croce-Carle Cuneo
Sponsor:
Collaborators:
GITIL (GRUPPO ITALIANO TERAPIE INNOVATIVE NEI LINFOMI)
Consorzio Mario Negri Sud
Information provided by (Responsible Party):
DR. ANDREA GALLAMINI, Ospedale Santa Croce-Carle Cuneo
ClinicalTrials.gov Identifier:
NCT00795613
First received: November 19, 2008
Last updated: February 2, 2012
Last verified: February 2012
History of Changes
  Purpose

The purpose of this multicenter clinical trial is to assess the clinical impact of dose intensification performed very early during treatment in a subset of poor prognosis, advanced-stage Hodgkin Lymphoma patients, defined as PET-positive after two courses of conventional adriamycin (doxorubicin), bleomycin, vinblastine and dacarbazine (ABVD) chemotherapy.


Condition Intervention Phase
HODGKIN LYMPHOMA
 Drug: ESCALATED BEACOPP
Drug: CONVENTIONAL ABVD
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Clinical Study With Early Treatment Intensification In Patients With High- Risk Hodgkin Lymphoma, Identified As FDG-PET Scan Positive After 2 Conventional ABVD Courses

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ospedale Santa Croce-Carle Cuneo:

Primary Outcome Measures:
  • progression-free survival (PFS) [ Time Frame: 3 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • event-free survival (EFS) [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 450
Study Start Date: June 2008
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PET pos
Patients With Interim Pet Positive Proceed To Escalated Beacopp Regimen
 Drug: ESCALATED BEACOPP
Esc.BEACOPP Bleomicine10 mg/m2/ev/die 8° VP-16 200 mg/m2/ev/die1°- 3° Doxorubicine35 mg/m2/ev/die 1° Cyclophosphamide1250 mg/m2/ev/die 1° Vincristine1,4 mg/m2(max dose 2 mg)/ev/die 8° Procarbazine100 mg/m2/b.m./die 1°- 7° Prednison40 mg/m2/b.m./die 1°-14° G-CSF300mcg/die s/c from day 8 until PMN>1000/ul Recycle every 21 days Esc.R-BEACOPP as above plus Rituximab 375 mg/m2/ev/ die 1° Recycle every 21 days Baseline BEACOPP Bleomicine10 mg/m2/ev/die 8° VP-16 100 mg/m2/ev/die 1°-3° Doxorubicine25 mg/m2/ev/die 1° Cyclophosphamide650 mg/m2/ev/die 1° Vincrinstine1,4 mg/m2(max dose 2 mg)/ev/die 8° Procarbazine100 mg/m2/os/die 1°-7° Prednison40 mg/m2/os/die 1°-14° Recycle every 21 days Baseline R-BEACOPP as above plus Rituximab375 mg/m2/ev/ die 1° Recycle every 21 days
Other Names:
  • BLEOMICINE TEVA
  • VEPESID
  • DOXORUBICINE TEVA
  • ENDOXAN
  • VINCRISTINE TEVA
  • NATULAN
  • DELTACORTENE
  • MABTHERA
PET negative
Patients With Interim-Pet Negative Continue The Conventional ABVD Regimen
 Drug: CONVENTIONAL ABVD
ABVD(cycle repeats every 28 days) Doxorubicine25 mg/m2 iv days 1,15 Bleomicine10,000 units/m2 iv days 1,15 Vinblastine6 mg/m2 iv days 1,15 Dacarbazine375mg/m2 iv days 1,15 This will be given at full dose and on schedule,regardless of blood count.
Other Names:
  • BLEOMICINE TEVA
  • DOXORUBICINE TEVA
  • VELBE
  • NATULAN

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with advanced classical Hodgkin Lymphoma according to the World Health Organization classification
  • Aged 18-60
  • Not previously treated
  • Stages IIB to IV B
  • All IPS prognostic groups
  • Patients who have signed an informed consent form

Exclusion Criteria:

  • Patients aged more than 60.
  • Concomitant or previously treated neoplastic disorder less than 5 year before the diagnosis of Hodgkin's lymphoma.
  • Psychiatric disorders
  • Uncontrolled infectious disease
  • Impaired cardiac (EF < 50%) , renal (creatinine clearance < 60 ml/m)
  • HIV, HBV DNA, HCV RNA positive markers
  • Pregnancy and lactation
  • Patients with uncompensated diabetes mellitus and fasting glucose levels over 200 mg/dl
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00795613

Contacts
Contact: ANDREA GALLAMINI, MD +39 0171 642414 gallamini.a@ospedale.cuneo.it
Contact: MARIA R. MENNITTO, PHARMACIST +39 0872 570250 HD0607@negrisud.it

Locations
Israel
The Chaim Sheba Medical Center Recruiting
Tel Hashomer, Israel
Contact: ABRAHAM AVIGDOR, MD            
Principal Investigator: ABRAHAM AVIGDOR, MD            
Italy
Ospedale S. Gerardo Recruiting
Monza, Milano, Italy, 20052
Principal Investigator: ENRICO POGLIANI, MD            
A.O. Universitaria S. Luigi Gonzaga Recruiting
Orbassano, Torino, Italy, 10043
Principal Investigator: GIUSEPPE SAGLIO, MD            
A.O. Universitaria Ospedali Riuniti Osp. Umberto I Recruiting
Ancona, Italy, 60100
Principal Investigator: PIETRO LEONI, MD            
Ospedali Riuniti Recruiting
Bergamo, Italy, 24128
Principal Investigator: RAMBALDI ALESSANDRO, MD            
Ospedale Generale Regionale Bolzano Recruiting
Bolzano, Italy, 39100
Principal Investigator: SERGIO CORTELAZZO, MD            
Ospedale Roberto Binaghi Recruiting
Cagliari, Italy, 09126
Principal Investigator: GIORGIO LA NASA, MD            
A.O. Universitaria Osp. Vittorio Emanuele E Ferrarotto Recruiting
Catania, Italy, 95124
Principal Investigator: FRANCESCO DI RAIMONDO, MD            
Azienda Ospedaliera S. Croce E Carle Recruiting
Cuneo, Italy, 12100
Contact: ANDREA GALLAMINI, HEM DEP HEAD     +39 0171 642414     gallamini.a@ospedale.cuneo.it    
Sub-Investigator: CLAUDIA CASTELLINO, MD            
Sub-Investigator: FRANCESCA FIORE, MD            
Principal Investigator: ANDREA GALLAMINI, MD            
Azienda Ospedaliera Universitaria S. Martino Recruiting
Genova, Italy, 16126
Principal Investigator: MARCO GOBBI, MD            
Irccs - Istituto Nazionale Dei Tumori (Int) Recruiting
Milano, Italy, 20133
Principal Investigator: PAOLO CORRADINI, MD            
Ospedale S. Raffaele Turro Recruiting
Milano, Italy, 20127
Principal Investigator: FABIO CICERI, MD            
Irccs Istituto Nazionale Dei Tumori (Int) Recruiting
Milano, Italy, 20133
Principal Investigator: ALESSANDRO MA GIANNI, MD            
A.O. Universitaria Federico Ii Recruiting
Napoli, Italy, 80131
Principal Investigator: FABRIZIO PANE, MD            
Azienda Ospedaliera Recruiting
Padova, Italy, 35127
Principal Investigator: GIAMPIETRO SEMENZATO, MD            
Azienda Ospedaliera V. Cervello Recruiting
Palermo, Italy, 90146
Sub-Investigator: CATERINA PATTI, MD            
Principal Investigator: MIRTO SALVO, MD            
Ospedale Silvestrini-S.Andrea Delle Fratte Recruiting
Perugia, Italy, 06156
Principal Investigator: LEONARDO FLENGHI, MD            
Ospedale S. Carlo Recruiting
Potenza, Italy, 85100
Principal Investigator: ATTILIO OLIVIERI, MD            
A.O. Universitaria Policlinico Tor Vergata Recruiting
Roma, Italy, 00133
Principal Investigator: SERGIO AMADORI, MD            
Azienda Ospedaliera San Camillo-Forlanini Recruiting
Roma, Italy, 00149
Principal Investigator: IGNAZIO MAJOLINO, MD            
A.O. Universitaria S. Giovanni Battista-Molinette Recruiting
Torino, Italy, 10134
Principal Investigator: PAOLO GAVAROTTI, MD            
Ospedale Mauriziano Umberto I Recruiting
Torino, Italy, 10128
Principal Investigator: CORRADO TARELLA, MD            
Ospedale Policlinico G.B. Rossi Recruiting
Verona, Italy, 37134
Principal Investigator: GIOVANNI PIZZOLO, MD            
Ospedale Di Vicenza Recruiting
Vicenza, Italy, 36100
Principal Investigator: FRANCESCO RODEGHIERO, MD            
Sponsors and Collaborators
Ospedale Santa Croce-Carle Cuneo
GITIL (GRUPPO ITALIANO TERAPIE INNOVATIVE NEI LINFOMI)
Consorzio Mario Negri Sud
Investigators
Study Chair: ANDREA GALLAMINI, MD A.S.O. S.CROCE E CARLE-HEMATOLOGY DEPT. - VIA M. COPPINO 26-12100 CUNEO ITALY
  More Information

Additional Information:
Link of Consorzio Mario Negri Sud which gives some brief information about HD0607 clinical trial  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: DR. ANDREA GALLAMINI, HEAD OF HAEMATOLOGY DEPT. A.S.O. S. CROCE AND CARLE, Ospedale Santa Croce-Carle Cuneo
ClinicalTrials.gov Identifier: NCT00795613     History of Changes
Other Study ID Numbers: GITIL - HD0607
Study First Received: November 19, 2008
Last Updated: February 2, 2012
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

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
Doxorubicin
Procarbazine
 Vincristine
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 23, 2013