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

NCT00795613 | Unknown Phase 2 DMC

• 1 other identifier: GITIL - HD0607
• Study Type: interventional
• Target: 450
• Locations: 2 countries
• Sites: 24

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.

Conditions

HODGKIN LYMPHOMA

Keywords

PET

Outcome Measures

Primary Outcomes (1)

• progression-free survival (PFS)

  3 year

Secondary Outcomes (1)

• event-free survival (EFS)

  3 year

Study Arms (2)

PET pos

EXPERIMENTAL

Patients With Interim Pet Positive Proceed To Escalated Beacopp Regimen

Drug: ESCALATED BEACOPP

PET negative

OTHER

Patients With Interim-Pet Negative Continue The Conventional ABVD Regimen

Drug: CONVENTIONAL ABVD

Interventions

ESCALATED BEACOPP DRUG

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

Also known as: BLEOMICINE TEVA, VEPESID, DOXORUBICINE TEVA, ENDOXAN, VINCRISTINE TEVA, NATULAN, DELTACORTENE, MABTHERA

PET pos

CONVENTIONAL ABVD DRUG

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.

Also known as: BLEOMICINE TEVA, DOXORUBICINE TEVA, VELBE, NATULAN

PET negative

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ospedale Santa Croce-Carle Cuneo: lead
• GITIL (GRUPPO ITALIANO TERAPIE INNOVATIVE NEI LINFOMI): collaborator
• Consorzio Mario Negri Sud: collaborator

Study Sites (24)

The Chaim Sheba Medical Center

Tel Litwinsky, Israel

Location

Ospedale S. Gerardo

Monza, Milano, 20052, Italy

Location

A.O. Universitaria S. Luigi Gonzaga

Orbassano, Torino, 10043, Italy

Location

A.O. Universitaria Ospedali Riuniti Osp. Umberto I

Ancona, 60100, Italy

Location

Ospedali Riuniti

Bergamo, 24128, Italy

Location

Ospedale Generale Regionale Bolzano

Bolzano, 39100, Italy

Location

Ospedale Roberto Binaghi

Cagliari, 09126, Italy

Location

A.O. Universitaria Osp. Vittorio Emanuele E Ferrarotto

Catania, 95124, Italy

Location

Azienda Ospedaliera S. Croce E Carle

Cuneo, 12100, Italy

Location

Azienda Ospedaliera Universitaria S. Martino

Genova, 16126, Italy

Location

Ospedale S. Raffaele Turro

Milan, 20127, Italy

Location

Irccs - Istituto Nazionale Dei Tumori (Int)

Milan, 20133, Italy

Location

Irccs Istituto Nazionale Dei Tumori (Int)

Milan, 20133, Italy

Location

A.O. Universitaria Federico Ii

Napoli, 80131, Italy

Location

Azienda Ospedaliera

Padua, 35127, Italy

Location

Azienda Ospedaliera V. Cervello

Palermo, 90146, Italy

Location

Ospedale Silvestrini-S.Andrea Delle Fratte

Perugia, 06156, Italy

Location

Ospedale S. Carlo

Potenza, 85100, Italy

Location

A.O. Universitaria Policlinico Tor Vergata

Roma, 00133, Italy

Location

Azienda Ospedaliera San Camillo-Forlanini

Roma, 00149, Italy

Location

Ospedale Mauriziano Umberto I

Torino, 10128, Italy

Location

A.O. Universitaria S. Giovanni Battista-Molinette

Torino, 10134, Italy

Location

Ospedale Policlinico G.B. Rossi

Verona, 37134, Italy

Location

Ospedale Di Vicenza

Vicenza, 36100, Italy

Location

Related Publications (5)

• 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. doi: 10.1200/JCO.2007.11.6525. Epub 2007 Jul 23.

  PMID: 17646666 BACKGROUND

• 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.

  PMID: 16585014 BACKGROUND

• Kreuzberger N, Goldkuhle M, von Tresckow B, Kobe C, Sickinger MT, Monsef I, Skoetz N. Positron emission tomography-adapted therapy for first-line treatment in adults with Hodgkin lymphoma. Cochrane Database Syst Rev. 2025 Mar 26;3(3):CD010533. doi: 10.1002/14651858.CD010533.pub3.

  PMID: 40135712 DERIVED

• Gallamini A, Rossi A, Patti C, Picardi M, Romano A, Cantonetti M, Oppi S, Viviani S, Bolis S, Trentin L, Gini G, Battistini R, Chauvie S, Sorasio R, Pavoni C, Zanotti R, Cimminiello M, Schiavotto C, Viero P, Mule A, Fallanca F, Ficola U, Tarella C, Guerra L, Rambaldi A. Consolidation Radiotherapy Could Be Safely Omitted in Advanced Hodgkin Lymphoma With Large Nodal Mass in Complete Metabolic Response After ABVD: Final Analysis of the Randomized GITIL/FIL HD0607 Trial. J Clin Oncol. 2020 Nov 20;38(33):3905-3913. doi: 10.1200/JCO.20.00935. Epub 2020 Sep 18.

  PMID: 32946355 DERIVED

• Gallamini A, Tarella C, Viviani S, Rossi A, Patti C, Mule A, Picardi M, Romano A, Cantonetti M, La Nasa G, Trentin L, Bolis S, Rapezzi D, Battistini R, Gottardi D, Gavarotti P, Corradini P, Cimminiello M, Schiavotto C, Parvis G, Zanotti R, Gini G, Ferreri AJM, Viero P, Miglino M, Billio A, Avigdor A, Biggi A, Fallanca F, Ficola U, Gregianin M, Chiaravalloti A, Prosperini G, Bergesio F, Chauvie S, Pavoni C, Gianni AM, Rambaldi A. Early Chemotherapy Intensification With Escalated BEACOPP in Patients With Advanced-Stage Hodgkin Lymphoma With a Positive Interim Positron Emission Tomography/Computed Tomography Scan After Two ABVD Cycles: Long-Term Results of the GITIL/FIL HD 0607 Trial. J Clin Oncol. 2018 Feb 10;36(5):454-462. doi: 10.1200/JCO.2017.75.2543. Epub 2018 Jan 23.

  PMID: 29360414 DERIVED

Related Links

• Link of Consorzio Mario Negri Sud which gives some brief information about HD0607 clinical trial

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Etoposide; Cyclophosphamide; Procarbazine; deltacortene; Rituximab; Vinblastine

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• ANDREA GALLAMINI, MD

  A.S.O. S.CROCE E CARLE-HEMATOLOGY DEPT. - VIA M. COPPINO 26-12100 CUNEO ITALY

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: HEAD OF HAEMATOLOGY DEPT. A.S.O. S. CROCE AND CARLE

Study Record Dates

• First Submitted: November 19, 2008
• First Posted: November 21, 2008
• Study Start: June 1, 2008
• Primary Completion: November 1, 2014
• Study Completion: October 1, 2015
• Last Updated: October 19, 2015

Record last verified: 2015-10

Locations

IL (1); IT (23)