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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00044733 |
The primary objective of this study is to evaluate the safety of gemtuzumab ozogamicin in relapsed CD33-positive AML patients who received HSCT. If the MTD dose is not reached, 9 mg/m2 will be the maximum tested dose. A secondary objective is to assess efficacy in terms of the number of patients attaining a complete (CR) or morphological (CRp) remission.
Condition | Intervention | Phase |
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Acute Myelogenous Leukemia |
Drug: Mylotarg (gemtuzumab ozogamicin) Injection |
Phase II |
Study Type: | Interventional |
Study Design: | Open Label |
Official Title: | A Dose-Finding Study of the Safety of Gemtuzumab Ozogamicin as Single Agent Treatment of Patients With Relapsed Acute Myelogenous Leukemia After Autologous or Allogenic Hematopoietic Stem Cell Transplant (HSCT) |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
United States, Arkansas | |
Little Rock, Arkansas, United States, 72211 | |
United States, Connecticut | |
Hartford, Connecticut, United States, 06102 | |
United States, Florida | |
Jacksonville, Florida, United States, 32209 | |
United States, Hawaii | |
Honolulu, Hawaii, United States, 96813 | |
United States, Kansas | |
Olathe, Kansas, United States, 66061 | |
United States, New Jersey | |
Camden, New Jersey, United States, 08103 | |
Trenton, New Jersey, United States, 08629 | |
United States, New York | |
Rochester, New York, United States, 14642 | |
Buffalo, New York, United States, 14215 | |
United States, Ohio | |
Canton, Ohio, United States, 44708 | |
United States, Texas | |
Houston, Texas, United States, 77030 | |
United States, West Virginia | |
Charleston, West Virginia, United States, 25304 | |
United States, Wisconsin | |
Madison, Wisconsin, United States, 53792 |
Study Director: | Medical Monitor, MD | Wyeth |
Study ID Numbers: | 0903X-100374 |
Study First Received: | September 4, 2002 |
Last Updated: | May 17, 2006 |
ClinicalTrials.gov Identifier: | NCT00044733 |
Health Authority: | United States: Food and Drug Administration |
Leukemia Stem Cell Transplant |
Antibodies, Monoclonal Signs and Symptoms Leukemia Antibodies Acute myelogenous leukemia |
Leukemia, Myeloid Gemtuzumab Leukemia, Myeloid, Acute Acute myelocytic leukemia Immunoglobulins |
Neoplasms Neoplasms by Histologic Type Immunologic Factors Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Pharmacologic Actions |