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First in Human Study to Determine the Safety, Tolerability and Preliminary Effectiveness of MDX-1338 (BMS 936564) in Subjects With Acute Myelogenous Leukemia (AML)
Complete title: A Phase 1, Open-Label, Multicenter Study of MDX-1338/BMS936564 in Subjects with Relapsed/Refractory Acute Myelogenous Leukemia
| Research Study Number | 20100803 | ||
| Principal Investigator | Pamela Becker, MD, PhD | ||
| Phase | I |
Research Study Description
To determine 1) the safety and tolerability of multiple IV doses of MDX-1338 (BMS-936564) as monotherapy, and 2) the maximum tolerated dose (MTD) of MDX-1338 (BMS-936564) as monotherapy (monotherapy MTD) in subjects with relapsed/refractory AML.
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- Relapsed/refractory AML (M3 excluded) for which no standard therapies are anticipated to result in a durable remission or are unsuitable for standard therapy. If relapsed, no more than 2 relapses are allowed. If refractory, must be primary refractory to at least 1 induction regimen. Secondary AML subjects from MDS or prior chemotherapy are eligible. MDS-only subjects are not eligible
- Life expectancy at least 12 weeks
- ECOG Performance Status of 0-2
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- Myelodysplastic syndrome (MDS)
- Any other malignancy, excluding basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, localized prostate cancer, or superficial bladder cancer stage 0, from which the subject has not been disease-free for at least 3 years
- History of severe hypersensitivity reactions to other monoclonal antibodies
- Known central nervous system (CNS) involvement
Other exclusion criteria may apply.
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Keywords
Acute Myeloid Leukemia (AML); Hematologic Malignancies; Leukemia
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Please remember:
- Talk to your health care providers first before making decisions about your health care.
- Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.
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