CLAG Gleevec in Relapsed or Refractory Acute Myeloid Leukemia (AML)
The purpose of this study is to evaluate the safety of combined chemotherapy treatment regimen with cladribine (2-CDA), cytarabine, and granulocyte colony-stimulating factor (G-CSF) [CLAG] with Gleevec® (imatinib mesylate).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of CLAG Regimen in Combination With Imatinib Mesylate (Gleevec) in Relapsed or Refractory Acute Myeloid Leukemia|
- Participants' Overall Response (OR) [ Time Frame: 12 weeks per patient ] [ Designated as safety issue: No ]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.
- Number of Participants With Progression Free Survival (PFS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Number of Participants With Overall Survival (OS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||August 2009|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Experimental: CLAG Regimen with Gleevec®
Combined chemotherapy treatment (CLAG regimen) with Gleevec® (imatinib mesylate).
Drug: CLAG Regimen
Combination of chemotherapy drugs. Cladribine, Days 2 - 6, 2 hour infusion. Cytarabine, Days 2 - 6, 4 hour infusion. Neupogen, Days 1 - 6, Given 12 - 24 hours before 1st dose of cladribine.
Other Names:Drug: Gleevec®
Days 2 - 15, Pill taken twice a day
Other Name: imatinib mesylate
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 blast crisis.
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.
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Rami Komrokji, M.D.||H. Lee Moffitt Cancer Center and Research Institute|