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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
Closed 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.


Investigator
Pamela S. Becker, MD, PhD
Location    
Seattle Cancer Care Alliance 800-804-8824  
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
February 05, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

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.