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Leukemia

Safety Study of SGN-CD33A Acute Myeloid Leukemia (2690)
A Phase 1 Trial of SGN-CD33A in Patients with CD33-Positive Acute Myeloid Leukemia
Status Conditions Phase Study ID
Recruiting Acute Myeloid Leukemia (AML) Phase I 2690
NCT01902329
Summary

This study will examine the safety profile of SGN-CD33A administered as a single agent. The main purpose of the study is to find the maximum tolerated dose (MTD, which is the highest dose that does not cause unacceptable side effects) of SGN-CD33A in patients with acute myeloid leukemia (AML). The MTD will be determined by observing the dose-limiting toxicities (the side effects that prevent further increases in dose) of SGN-CD33A. In addition, the pharmacokinetic profile and anti-leukemia activity of SGN-CD33A will be assessed.


Investigator
Roland Walter, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • Acute myeloid leukemia, positive for CD33
  • Eastern Cooperative Onocology Group status of 0 or 1
  • Adequate baseline renal and hepatic function
  • Central venous access
  • Either achieved complete remission (greater than 12 weeks in duration) with initial induction/consolidation and have experienced relapse of disease or declined treatment with high-dose induction/consolidation
  • Bone marrow blasts greater than or equal to 5% for relapsed patients, or greater than or equal to 20% for untreated patients
Exclusions (conditions that would prevent participation in this study)
  • Inadequate lung function
  • Prior stem cell transplant
  • High-dose chemotherapy within 4 weeks of study drug
  • Antileukemia treatment within 14 days of study drug (other than hydroxyurea or 6-mercaptopurine)
Last Updated
August 06, 2013
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.