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
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Condition or disease | Intervention/treatment | Phase |
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HODGKIN LYMPHOMA | Drug: ESCALATED BEACOPP Drug: CONVENTIONAL ABVD | Phase 2 |

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 |

Arm | Intervention/treatment |
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Experimental: PET pos
Patients With Interim Pet Positive Proceed To Escalated Beacopp Regimen
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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:
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PET negative
Patients With Interim-Pet Negative Continue The Conventional ABVD Regimen
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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:
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- progression-free survival (PFS) [ Time Frame: 3 year ]
- event-free survival (EFS) [ Time Frame: 3 year ]

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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

Study Chair: | ANDREA GALLAMINI, MD | A.S.O. S.CROCE E CARLE-HEMATOLOGY DEPT. - VIA M. COPPINO 26-12100 CUNEO ITALY |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Other Study ID Numbers: |
GITIL - HD0607 |
First Posted: | November 21, 2008 Key Record Dates |
Last Update Posted: | October 19, 2015 |
Last Verified: | October 2015 |
PET |
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 |