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

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ClinicalTrials.gov Identifier: NCT00795613
Recruitment Status : Unknown
Verified October 2015 by DR. ANDREA GALLAMINI, Ospedale Santa Croce-Carle Cuneo.
Recruitment status was:  Active, not recruiting
First Posted : November 21, 2008
Last Update Posted : October 19, 2015
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

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
HODGKIN LYMPHOMA Drug: ESCALATED BEACOPP Drug: CONVENTIONAL ABVD Phase 2

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2008
Actual Primary Completion Date : November 2014
Estimated Study Completion Date : October 2015

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. progression-free survival (PFS) [ Time Frame: 3 year ]

Secondary Outcome Measures :
  1. event-free survival (EFS) [ Time Frame: 3 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00795613


Locations
Israel
The Chaim Sheba Medical Center
Tel Hashomer, Israel
Italy
Ospedale S. Gerardo
Monza, Milano, Italy, 20052
A.O. Universitaria S. Luigi Gonzaga
Orbassano, Torino, Italy, 10043
A.O. Universitaria Ospedali Riuniti Osp. Umberto I
Ancona, Italy, 60100
Ospedali Riuniti
Bergamo, Italy, 24128
Ospedale Generale Regionale Bolzano
Bolzano, Italy, 39100
Ospedale Roberto Binaghi
Cagliari, Italy, 09126
A.O. Universitaria Osp. Vittorio Emanuele E Ferrarotto
Catania, Italy, 95124
Azienda Ospedaliera S. Croce E Carle
Cuneo, Italy, 12100
Azienda Ospedaliera Universitaria S. Martino
Genova, Italy, 16126
Ospedale S. Raffaele Turro
Milano, Italy, 20127
Irccs - Istituto Nazionale Dei Tumori (Int)
Milano, Italy, 20133
Irccs Istituto Nazionale Dei Tumori (Int)
Milano, Italy, 20133
A.O. Universitaria Federico Ii
Napoli, Italy, 80131
Azienda Ospedaliera
Padova, Italy, 35127
Azienda Ospedaliera V. Cervello
Palermo, Italy, 90146
Ospedale Silvestrini-S.Andrea Delle Fratte
Perugia, Italy, 06156
Ospedale S. Carlo
Potenza, Italy, 85100
A.O. Universitaria Policlinico Tor Vergata
Roma, Italy, 00133
Azienda Ospedaliera San Camillo-Forlanini
Roma, Italy, 00149
Ospedale Mauriziano Umberto I
Torino, Italy, 10128
A.O. Universitaria S. Giovanni Battista-Molinette
Torino, Italy, 10134
Ospedale Policlinico G.B. Rossi
Verona, Italy, 37134
Ospedale Di Vicenza
Vicenza, Italy, 36100
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
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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
First Posted: November 21, 2008    Key Record Dates
Last Update Posted: October 19, 2015
Last Verified: October 2015

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

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Doxorubicin
Liposomal doxorubicin
Vincristine
 Procarbazine
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators