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Positron Emission Tomography (PET)-Adapted Chemotherapy In Advanced Hodgkin Lymphoma (HL) (HD0607)
This study is ongoing, but not recruiting participants.
Sponsor:
Ospedale Santa Croce-Carle Cuneo
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: October 16, 2015
Last verified: October 2015
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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 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 |
Resource links provided by NLM:
Further study details as provided by DR. ANDREA GALLAMINI, Ospedale Santa Croce-Carle Cuneo:
Primary Outcome Measures:
- progression-free survival (PFS) [ Time Frame: 3 year ]
Secondary Outcome Measures:
- event-free survival (EFS) [ Time Frame: 3 year ]
| Estimated Enrollment: | 450 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | October 2015 |
| Primary Completion Date: | November 2014 (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:
|
|
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:
|
Show Detailed Description
Eligibility| 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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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
Please refer to this study by its ClinicalTrials.gov identifier: 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
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: | October 16, 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 |
ClinicalTrials.gov processed this record on August 23, 2017