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Sponsored by: |
Ospedali Riuniti di Bergamo |
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Information provided by: | Ospedali Riuniti di Bergamo |
ClinicalTrials.gov Identifier: | NCT00354822 |
Pilot multicentric, open label study with the aim to evaluate antitumor activity in term of sum of complete and partial response (O.R.R.) of chemotherapy (cyclophosphamide and fludarabine) followed by Zevalin radioimmunotherapy and response duration (Time to relapse or progression)and to evaluate the safety of the treatment as acute and late toxicity.
Secondary objective is to evaluate the overall survival (OS) and the event-free survival (EFS).
Condition | Intervention | Phase |
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Lymphoma, Non-Hodgkin |
Drug: Zevalin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study for Use of Oral Fludarabine Plus Cyclophosphamide Followed by Zevalin in the Treatment of Non-Follicular Indolent Lymphomas Refractory or Relapsed After Conventional Front-Line Chemotherapy Not Containing Fludarabine. |
Estimated Enrollment: | 80 |
Study Start Date: | August 2005 |
Estimated Study Completion Date: | August 2009 |
Test medication:
Main parameters of activity: Activity of Yttrium-90 (90Y) ibritumomab tiuxetan after Cytoxan and Fludarabine combination
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Delaini Federica, Dr | 0039035 266148 | oro@ospedaliriuniti.bergamo.it |
Italy, BG | |
USC Ematologia Ospedali Riuniti di Bergamo | Recruiting |
Bergamo, BG, Italy, 24128 | |
Contact: Delaini Federica, Dr 00390350266148 oro@ospedaliriuniti.bergamo.it | |
Principal Investigator: Rambaldi Alessandro, MD | |
Italy, ME | |
Sergio Baldari | Recruiting |
Messina, ME, Italy, 98125 | |
Principal Investigator: Baldari Sergio, MD | |
Italy, to | |
Massimo Aglietta | Not yet recruiting |
Candiolo, to, Italy, 10060 | |
Principal Investigator: Aglietta Massimo, MD | |
Italy, TV | |
Filippo Gherlinzoni | Not yet recruiting |
Treviso, TV, Italy, 31100 | |
Principal Investigator: Gherlinzoni Filippo, MD |
Principal Investigator: | Cortelazzo Sergio, MD | Ospedale Centrale di Bolzano (Italy) |
Study ID Numbers: | EUDRACT 2005-000699-41 |
Study First Received: | July 19, 2006 |
Last Updated: | July 19, 2006 |
ClinicalTrials.gov Identifier: | NCT00354822 |
Health Authority: | Italy: Ministry of Health |
Zevalin Lymphoma, Non-Hodgkin |
Lymphatic Diseases Immunoproliferative Disorders Fludarabine Fludarabine monophosphate |
Cyclophosphamide Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |
Neoplasms by Histologic Type Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |