Positron Emission Tomography (PET)-Adapted Chemotherapy In Advanced Hodgkin Lymphoma (HL) - Full Text View

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:

MedlinePlus related topics: Hodgkin Disease Lymphoma

Drug Information available for: Procarbazine hydrochloride Procarbazine Doxorubicin Doxorubicin hydrochloride

Genetic and Rare Diseases Information Center resources: Hodgkin Lymphoma Lymphosarcoma

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

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

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: 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
Irccs Istituto Nazionale Dei Tumori (Int)	Recruiting
Milano, Italy, 20133
Principal Investigator: ALESSANDRO MA GIANNI, MD
Ospedale S. Raffaele Turro	Recruiting
Milano, Italy, 20127
Principal Investigator: FABIO CICERI, 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:

Gallamini A, Hutchings M, Rigacci L, Specht L, Merli F, Hansen M, Patti C, Loft A, Di Raimondo F, D'Amore F, Biggi A, Vitolo U, Stelitano C, Sancetta R, Trentin L, Luminari S, Iannitto E, Viviani S, Pierri I, Levis A. Early interim 2-[18F]fluoro-2-deoxy-D-glucose positron emission tomography is prognostically superior to international prognostic score in advanced-stage Hodgkin's lymphoma: a report from a joint Italian-Danish study. J Clin Oncol. 2007 Aug 20;25(24):3746-52. Epub 2007 Jul 23.

Gallamini A, Rigacci L, Merli F, Nassi L, Bosi A, Capodanno I, Luminari S, Vitolo U, Sancetta R, Iannitto E, Trentin L, Stelitano C, Tavera S, Biggi A, Castagnoli A, Versari A, Gregianin M, Pelosi E, Torchio P, Levis A. The predictive value of positron emission tomography scanning performed after two courses of standard therapy on treatment outcome in advanced stage Hodgkin's disease. Haematologica. 2006 Apr;91(4):475-81.


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 Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Doxorubicin	Liposomal doxorubicin Antibiotics, Antineoplastic Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses Topoisomerase II Inhibitors Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on February 25, 2015

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