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Sponsors and Collaborators: |
Masonic Cancer Center, University of Minnesota Pfizer |
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Information provided by: | Masonic Cancer Center, University of Minnesota |
ClinicalTrials.gov Identifier: | NCT00276159 |
The purpose of this study is to evaluate the anti-tumor activity of 852A when used to treat certain hematologic malignancies not responding to standard treatment.
Condition | Intervention | Phase |
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Acute Lymphoblastic Leukemia Acute Myeloid Leukemia Non-Hodgkin's Lymphoma Hodgkin's Lymphoma Multiple Myeloma Chronic Lymphocytic Leukemia |
Drug: 852A |
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 852A Administered Subcutaneously in Patients With Hematologic Malignancies Not Responding to Standard Treatment |
Enrollment: | 6 |
Study Start Date: | January 2006 |
Study Completion Date: | November 2008 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
852A will be administered as a subcutaneous injection (SC) 2 times per week for 12 weeks (24 doses) with provisions for dose escalation or reduction based on tolerability
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Subjects are eligible for the study if they meet all of the following
Inclusion Criteria:
Diagnosis of one of the following hematologic malignancies not responding to at least 2 standard treatment regimens. Any criteria for persistent or recurrent disease acceptable, i.e. ≥5% blasts for acute leukemia.
Subjects will be excluded from the study if they meet any of the following Exclusion Criteria:
Had/have the following prior/concurrent therapy:
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | 05US02IMP-852A [Miller], MT2005-20 |
Study First Received: | January 11, 2006 |
Last Updated: | June 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00276159 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Leukemia Lymphoma Myeloma Hematology |
852A IRM Oncology |
Leukemia, Lymphoid Hematologic Neoplasms Blood Protein Disorders Paraproteinemias Leukemia, Myeloid, Acute Hemostatic Disorders Lymphoma, Small Cleaved-cell, Diffuse Leukemia Acute Myelocytic Leukemia Hemorrhagic Disorders Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-cell, Chronic Hodgkin Disease Lymphoma Acute Lymphoblastic Leukemia |
Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Hodgkin Lymphoma, Adult Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Hodgkin's Disease Leukemia, Myeloid Multiple Myeloma Lymphatic Diseases Chronic Lymphocytic Leukemia Leukemia, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Leukemia, Lymphoid Hematologic Neoplasms Blood Protein Disorders Paraproteinemias Leukemia, Myeloid, Acute Hemostatic Disorders Leukemia Neoplasms by Site Hemorrhagic Disorders Leukemia, Lymphocytic, Chronic, B-Cell Cardiovascular Diseases Lymphoma Hodgkin Disease Precursor Cell Lymphoblastic Leukemia-Lymphoma |
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Hematologic Diseases Vascular Diseases Leukemia, Myeloid Multiple Myeloma Lymphatic Diseases Neoplasms Lymphoma, Non-Hodgkin Leukemia, B-Cell Lymphoproliferative Disorders Neoplasms, Plasma Cell |