Philadelphia Chromosome-Positive Leukemia Study

Principal Investigator: Kelly McCaul, MD

Sub-Investigators: R. Vinod Parameswaran, MD; Mark R. Huber, MD; Stephen C. Medlin, DO; Amy K. Krie, MD; Addison R. Tolentino, MD; Michael Robinson, MD; Tammie V. Smart, CNP; Kristen D. Hurley, CNP

Study Coordinator: Erika Meyer, RN

Study Description: Phase 1/2 study of SKI-606 in Philadelphia Chromosome Positive Leukemias

Overview: The purpose of this clinical drug study is to determine the safety and effectiveness of an investigational medication in treating patients with either Philadelphia Chromosome-positive Chronic Myelogenous Leukemia (Ph⁺ CML) or Philadelphia Chromosome-positive Acute Lymphocytic Leukemia (Ph⁺ ALL).

Participation in this study is expected to last approximately 12 months. All drug capsules, tests, procedures and office visits relating to participation in the study will be provided, at no cost.

Inclusion Criteria:

• Males and females, aged 18 and older
• Diagnosis of Ph⁺ CML or Ph⁺ ALL with resitance to full-dose imatinib (≥600 mg) or an intolerance of any dose of imatinib
• At least 3 months post allogeneic stem cell transplantation
• Able to take daily oral capsules reliably
• Adequate bone marrow, hepatic and renal functions

Exclusion Criteria:

• Women who are pregnant, breastfeeding or planning to become pregnant
• Diagnosis of Philadelphia chromosome and bcr-abl negative CML
• Evidence of serious active infection, or significant medical or psychiatric illness

Contact:  Erika Meyer, RN

                 (605) 322-3086

                 erika.meyer@avera.org