Leukemia
Chemotherapy + AntiCXR4 for Relapsed or Refractory AML (UW09036)
A Phase 1, Open-label, Multicenter Study of MDX-1338 (BMS-936564) in Subjects With Relapsed/Refractory Acute Myelogenous Leukemia
| Status | Conditions | Phase | Study ID |
| Recruiting | Acute Myeloid Leukemia | Phase I |
UW09036 NCT01120457 |
Summary
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.
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Eligibility Criteria (must meet the following to participate in this study)
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Last Updated
November 07, 2012See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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