Leukemia

Millenium C41005

INDICATION:
Leukemia

TITLE:
A Phase 2 Trial of MLN8237, an Oral Aurora-A Kinase Inhibitor, in Adult Patients With Acute Myelogenous Leukemia and High-grade Myelodysplastic Syndrome

IRB NAME:
Copernicus Group, IRB

STATUS:
Closed

PHASE:
2

PURPOSE:
To estimate the anticancer activity of MLN8237 measured by the response rate in subjects with acute myelogenous leukemia (AML) or high-grade myelodysplastic syndrome (MDS)

ELIGIBILITY:
Candidates must:

• Be male or female, aged 18 years or older
• Have one of the following diagnoses:
  • Acute myelogenous leukemia (defined in WHO criteria) with >10% bone marrow or peripheral blood blasts. This includes patients with leukemia secondary to prior chemotherapy or resulting from an antecedent hematologic disorder who have failed to achieve CR or relapse after prior therapy and who are not candidates for potentially curative treatment options. Patients who are age 60 years or more and have not received prior therapy also are eligible if they are not candidates for standard induction chemotherapy. Patients with acute promyelocytic leukemia (APL) are not eligible
  • High grade MDS, defined as >10% blasts on bone marrow examination

DURATION:
15 visits over 12 months

CONTACT/ADDITIONAL INFO:
Isabella Rodrigues, PhD
Clinical Research Coordinator
908-277-8630