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Sponsored by: |
MedImmune LLC |
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Information provided by: | MedImmune LLC |
ClinicalTrials.gov Identifier: | NCT00538096 |
Condition | Intervention | Phase |
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Lymphoma, B-Cell Lymphoma, Non-Hodgkin |
Drug: MEDI-538 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | A Phase I, Multicenter, Open-Label, Single-Arm, Dose-Escalation, Study to Evaluate the Safety, Tolerability, and Antitumor Activity of Continuous Intravenous Infusion of the Bispecific T-Cell Engager MEDI-538 in Adults With B-Cell Non-Hodgkin's Lymphoma Not Eligible for Curative Therapy |
Estimated Enrollment: | 18 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
MEDI-538
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Drug: MEDI-538
1 of 3 target doses of MEDI-538 (5,μg/m2/24h) as a continuous IV infusion through a central line catheter. The initial treatment period will be 4 weeks in duration (Study Days 0-27), unless the patient discontinues treatment.
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2: Experimental
MEDI-538
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Drug: MEDI-538
1 of 3 target doses of MEDI-538 (10,μg/m2/24h) as a continuous IV infusion through a central line catheter. The initial treatment period will be 4 weeks in duration (Study Days 0-27), unless the patient discontinues treatment.
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3: Experimental
MEDI-538
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Drug: MEDI-538
1 of 3 target doses of MEDI-538 (15,μg/m2/24h) as a continuous IV infusion through a central line catheter. The initial treatment period will be 4 weeks in duration (Study Days 0-27), unless the patient discontinues treatment.
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Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Histologically confirmed B-cell NHL of one of the following classifications:
Exclusion Criteria:
Responsible Party: | MedImmune Inc. ( Karen L. Kaucic, M.D. ) |
Study ID Numbers: | MI-CP137 |
Study First Received: | September 28, 2007 |
Last Updated: | September 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00538096 |
Health Authority: | United States: Food and Drug Administration |
B-cell Non-Hodgkin's Lymphoma |
Lymphoma, B-Cell Lymphatic Diseases Immunoproliferative Disorders B-cell lymphomas |
Lymphoma, small cleaved-cell, diffuse Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |