A Phase II Study of CLAG Regimen in Combination With Imatinib Mesylate (Gleevec) in Relapsed or Refractory Acute Myeloid Leukemia
In relapsed or resistant acute myeloid leukemia (a type of blood cancer where immature blood
cells are increased, blocking normal blood cell production), different types of chemotherapy
are used for treatment. Patients responded to all the chemotherapies in similar ways, but
most of the responses did not last long if further stem cell transplantation was not done.
Gleevec is believed to work by interfering with the abnormal protein by blocking it from
telling the body to keep making more white blood cells that are abnormal.
The CLAG regimen is the standard chemotherapy used for relapsed AML (Acute Myeloid
Leukemia). This study will add Gleevec® to the regimen for a period of 14 days. Gleevec®
is approved by the Food and Drug Administration (FDA) for the treatment of chronic myeloid
leukemia (CML) and some types of acute lymphoblastic leukemia (ALL). Its use in combination
with CLAG regimen is considered experimental for the treatment of Acute Myeloid Leukemia/CML
The goal of the study is to find out what effects (good and bad) Gleevec® (Imatinib
mesylate) combined with chemotherapy has on you and your acute myeloid leukemia.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Participants' Overall Response (OR)
The primary endpoint is to determine the overall response rate as well as toxicity of CLAG-Gleevec combination regimen (Cladribine, cytarabine, G-CSF, and Imatinib Mesylate) in treatment of refractory or relapsed acute myeloid leukemia.
12 weeks per patient
Rami Komrokji, M.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Institutional Review Board
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|