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Sponsors and Collaborators: |
Fondazione Intergruppo Italiano Linfomi Onlus Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica (CPO) Piemonte |
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Information provided by: | Fondazione Intergruppo Italiano Linfomi Onlus |
ClinicalTrials.gov Identifier: | NCT00784537 |
The purpose of this study is to define an improvement in patients:
Condition | Intervention | Phase |
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Hodgkin's Lymphoma |
Drug: ABVD |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Early Salvage With High Dose Chemotherapy and Stem Cell Transplantation in Advanced Stage Hodgkin's Lymphoma Patients With Positive PET After Two Courses of ABVD (PET-2 Positive) and Comparison of RT Versus no RT in PET-2 Negative Patients |
Estimated Enrollment: | 300 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | December 2014 |
Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 1: Active Comparator
PET-6 negative patients will be randomized to first arm: No radiotherapy. |
Drug: ABVD
ABVD courses are scheduled every 28 days (see Appendix F): Doxorubicin 25 mg/m2 i.v. day 1 and 15 Bleomycin 10 mg/m2 i.v. day 1 and 15 Vinblastine 6 mg/m2 i.v. day 1 and 15 Dacarbazine 375 mg/m2 i.v. day 1 and 15 |
Arm 2: Active Comparator
Two courses of ABVD. Early restaging with FDG-PET scan (PET-2) The subsequent treatment will be as it follows:
The following restaging procedures are planned as it follows:
PET-6 negative patients will be randomized to first arm: Adjuvant radiotherapy (30 Gy) on sites of initial bulky disease. |
Drug: ABVD
ABVD courses are scheduled every 28 days (see Appendix F): Doxorubicin 25 mg/m2 i.v. day 1 and 15 Bleomycin 10 mg/m2 i.v. day 1 and 15 Vinblastine 6 mg/m2 i.v. day 1 and 15 Dacarbazine 375 mg/m2 i.v. day 1 and 15 |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Daniela Gioia, PhD | 0131/206129 | dgioia@ospedale.al.it |
Contact: Antonella Ferranti, PhD | 0131/206129 | aferranti@ospedale.al.it |
Study Director: | Alessandro Levis, MD | Ospedale SS. Antonio, Biagio e Cesare Arrigo |
Responsible Party: | A.O. SS. Antonio e Biagio e Cesare Arrigo ( Alessandro Levis ) |
Study ID Numbers: | IIL-HD0801, EudracT Number 2008−002684−14 |
Study First Received: | November 3, 2008 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00784537 |
Health Authority: | Italy: National Monitoring Centre for Clinical Trials - Ministry of Health |
Hodgkin's lymphoma ABVD |
Lymphatic Diseases Dacarbazine Hodgkin's disease Immunoproliferative Disorders Hodgkin lymphoma, adult Vinblastine |
Lymphoproliferative Disorders Bleomycin Hodgkin Disease Lymphoma Doxorubicin |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |