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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00283439 |
The purpose of this study is to identify a well-tolerated, effective dose and schedule of AMG 531 for the treatment of CIT in subjects with lymphoma receiving multi-cycle chemotherapy.
Condition | Intervention | Phase |
---|---|---|
Chemotherapy-Induced Thrombocytopenia Hodgkin's Lymphoma Non-Hodgkin's Lymphoma Cancer Oncology Thrombocytopenia |
Biological: AMG 531 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Supportive Care, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open Label Dose and Schedule Finding Trial to Evaluate the Safety and Efficacy of AMG 531 for Treatment of Severe Thrombocytopenia Due to Muli-Cycle Chemotherapy in Adult Subjects With Lymphoma. |
Enrollment: | 39 |
Study Start Date: | October 2005 |
Study Completion Date: | September 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Single Arm: AMG 531 Dose-Escalating Cohort Study: Experimental |
Biological: AMG 531
Planned Cohorts:
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20050144 |
Study First Received: | January 26, 2006 |
Last Updated: | October 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00283439 |
Health Authority: | United States: Food and Drug Administration |
NHL chemotherapy induced thrombocytopenia CIT ICE RICE Hodgkin's Lymphoma Non-Hodgkin's Lymphoma |
CHOP ESHAP DHAP R-CHOP R-ESHAP R-DHAP |
Immunoproliferative Disorders Hodgkin's disease Hematologic Diseases Blood Platelet Disorders Hodgkin lymphoma, adult Lymphoma, small cleaved-cell, diffuse Thrombocytopathy |
Signs and Symptoms Lymphatic Diseases Thrombocytopenia Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Hodgkin Disease |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |