|Closed||Acute Myeloid Leukemia||Phase I||
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.
|Ages Eligible for Study:||18 Years and older|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
- 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
- Acute promyelocytic leukemia (M3)
- 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
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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