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Sponsored by: |
International Extranodal Lymphoma Study Group (IELSG) |
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Information provided by: | International Extranodal Lymphoma Study Group (IELSG) |
ClinicalTrials.gov Identifier: | NCT00210327 |
The primary objective of this study is to assess the antitumor activity (in terms of overall response rate - ORR
Condition | Intervention | Phase |
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Lymphoma, Mucosa-Associated Lymphoid Tissue |
Drug: Bortezomib (drug) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of VELCADE in Patients With Extranodal Marginal Zone B-cell Lymphoma of MALT-type Pretreated With Prior Systemic Therapy Regimen (X05142) |
Estimated Enrollment: | 33 |
Study Start Date: | July 2005 |
Study Completion Date: | April 2009 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
for primary gastric localized H. pylori-positive disease at diagnosis:
Exclusion Criteria:
pregnant or lactating status, confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening.
Pregnancy testing is not required for post-menopausal or surgically sterilized women
Switzerland | |
Oncology Institute of Southern Switzerland (IOSI) | |
Bellinzona, Switzerland, 6500 |
Study Chair: | Franco Cavalli, MD | International Extranodal Lymphoma Study Group |
Responsible Party: | IELSG ( International Extranodal Lymphoma Study Group (IELSG) ) |
Study ID Numbers: | IELSG25A |
Study First Received: | September 13, 2005 |
Last Updated: | July 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00210327 History of Changes |
Health Authority: | Switzerland: Swissmedic |
Lymphoma, B-Cell Lymphatic Diseases Immunoproliferative Disorders B-cell Lymphomas Bortezomib |
Lymphoma, B-Cell, Marginal Zone Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |
Lymphoma, B-Cell Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Lymphoma, B-Cell, Marginal Zone Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |